Ignite Creation Date:
2025-12-25 @ 1:24 AM
Ignite Modification Date:
2025-12-31 @ 4:02 PM
Study NCT ID:
NCT03288493
Status:
TERMINATED
Last Update Posted:
2024-03-28
First Post:
2017-09-13
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-05-18', 'type': 'ACTUAL'}}}}, 'conditionBrowseModule': {'meshes': [{'id': 'D009101', 'term': 'Multiple Myeloma'}], 'ancestors': [{'id': 'D054219', 'term': 'Neoplasms, Plasma Cell'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D020141', 'term': 'Hemostatic Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D010265', 'term': 'Paraproteinemias'}, {'id': 'D001796', 'term': 'Blood Protein Disorders'}, {'id': 'D006402', 'term': 'Hematologic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D006474', 'term': 'Hemorrhagic Disorders'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'rbelani@poseida.com', 'phone': '858-779-3100', 'title': 'Rajesh Belani, MD, Vice President Clinical Development', 'organization': 'Poseida Therapeutics'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Baseline through Month 24', 'description': 'Treatment-emergent adverse events (TEAEs) are protocol-defined AEs that occur from the date of P-BCMA-101 infusion until study completion or subject withdrawal from study. Coded to system organ class and preferred term.', 'eventGroups': [{'id': 'EG000', 'title': 'Phase 1: P-BCMA-101 CAR-T Cells', 'description': 'Single administration dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 69, 'deathsNumAtRisk': 69, 'otherNumAffected': 63, 'seriousNumAtRisk': 69, 'deathsNumAffected': 23, 'seriousNumAffected': 39}, {'id': 'EG001', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells (Cohort A)', 'description': 'Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG002', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells (Cohort B)', 'description': 'Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 1, 'deathsNumAtRisk': 1, 'otherNumAffected': 1, 'seriousNumAtRisk': 1, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG003', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort R)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 8, 'deathsNumAtRisk': 8, 'otherNumAffected': 7, 'seriousNumAtRisk': 8, 'deathsNumAffected': 3, 'seriousNumAffected': 7}, {'id': 'EG004', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RP)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 5, 'seriousNumAtRisk': 5, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG005', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.', 'otherNumAtRisk': 16, 'deathsNumAtRisk': 16, 'otherNumAffected': 16, 'seriousNumAtRisk': 16, 'deathsNumAffected': 0, 'seriousNumAffected': 6}, {'id': 'EG006', 'title': 'Phase 2: P-BCMA-101 CAR-T Cells', 'description': 'CAR-T cells administered via intravenous infusion as a total dose', 'otherNumAtRisk': 3, 'deathsNumAtRisk': 3, 'otherNumAffected': 3, 'seriousNumAtRisk': 3, 'deathsNumAffected': 1, 'seriousNumAffected': 2}, {'id': 'EG007', 'title': 'Retreatment', 'description': "If a subject's disease progressed and sufficient P-BCMA-101 cells were available from initial manufacturing, a subject may have received an additional P-BCMA-101 infusion at up to the highest dose level that had completed DLT assessment.", 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 4, 'seriousNumAtRisk': 5, 'deathsNumAffected': 2, 'seriousNumAffected': 2}], 'otherEvents': [{'term': 'Neutropenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 189, 'numAffected': 48}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 12, 'numAffected': 5}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 32, 'numAffected': 13}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 6, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Thrombocytopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 132, 'numAffected': 32}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 8, 'numAffected': 5}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 8, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 4, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Anaemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 92, 'numAffected': 33}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 2}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 5}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 2}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Leukopenia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 49, 'numAffected': 20}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 6, 'numAffected': 3}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 5, 'numAffected': 3}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 10, 'numAffected': 6}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 8, 'numAffected': 2}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 3, 'numAffected': 3}], 'organSystem': 'Blood and lymphatic system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Nausea', 'stats': [{'groupId': 'EG000', 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 10, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Lymphocyte count decreased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 7}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 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'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Hypophosphataemia', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 29, 'numAffected': 15}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG002', 'numAtRisk': 1, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG003', 'numAtRisk': 8, 'numEvents': 3, 'numAffected': 1}, {'groupId': 'EG004', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG005', 'numAtRisk': 16, 'numEvents': 2, 'numAffected': 2}, {'groupId': 'EG006', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG007', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Metabolism and nutrition disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 23.0'}, {'term': 'Decreased appetite', 'stats': [{'groupId': 'EG000', 'numAtRisk': 69, 'numEvents': 13, 'numAffected': 12}, {'groupId': 'EG001', 'numAtRisk': 3, 'numEvents': 0, 'numAffected': 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Response Criteria for Multiple Myeloma:\n\nOverall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nTime to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nDuration of Response 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'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies', 'timeFrame': 'Baseline through Month 24', 'description': 'Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)', 'timeFrame': 'Baseline through Month 24', 'description': 'Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 2: Evaluate Efficacy Endpoints (IL-6)', 'timeFrame': 'Baseline through Month 24', 'description': 'Rate of IL-6 antagonist', 'reportingStatus': 'NOT_POSTED', 'denomUnitsSelected': 'Participants'}, {'type': 'SECONDARY', 'title': 'Phase 2: Evaluate Efficacy Endpoints 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Rimiducid may be administered as indicated.'}, {'id': 'BG005', 'title': 'Phase 1 P-BCMA-101 CAR-T Cells With Comb.Therapy (Cohort RIT)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. 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'groupId': 'BG007'}]}, {'title': '>=65 years', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '8', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '45', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '7', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '39', 'groupId': 'BG007'}]}, {'title': 'Male', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '9', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '66', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '7', 'groupId': 'BG007'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '14', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '92', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '1', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '6', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '1', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '3', 'groupId': 'BG007'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Black or African American', 'measurements': [{'value': '13', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '2', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '3', 'groupId': 'BG005'}, {'value': '1', 'groupId': 'BG006'}, {'value': '20', 'groupId': 'BG007'}]}, {'title': 'White', 'measurements': [{'value': '48', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '6', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}, {'value': '10', 'groupId': 'BG005'}, {'value': '2', 'groupId': 'BG006'}, {'value': '71', 'groupId': 'BG007'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}, {'value': '0', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '0', 'groupId': 'BG007'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '2', 'groupId': 'BG004'}, {'value': '2', 'groupId': 'BG005'}, {'value': '0', 'groupId': 'BG006'}, {'value': '11', 'groupId': 'BG007'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '8', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}, {'value': '16', 'groupId': 'BG005'}, {'value': '3', 'groupId': 'BG006'}, {'value': '105', 'groupId': 'BG007'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-09-20', 'size': 1036384, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-04-19T17:12', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': 'Phase 1: open label, 3 + 3 design of dose-escalating cohorts Phase 2: open label, administered as a total dose'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 105}}, 'statusModule': {'whyStopped': 'Phase I portion of the study was completed. The phase II portion of the study was terminated early to focus on an Allogeneic BCMA CAR-T program.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-03-26', 'studyFirstSubmitDate': '2017-09-13', 'resultsFirstSubmitDate': '2023-04-25', 'studyFirstSubmitQcDate': '2017-09-18', 'lastUpdatePostDateStruct': {'date': '2024-03-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-26', 'studyFirstPostDateStruct': {'date': '2017-09-20', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-27', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1: Assess the Safety of P-BCMA-101', 'timeFrame': 'Baseline through Day 28', 'description': 'Incidence and severity of treatment-emergent adverse events'}, {'measure': 'Phase 1: Maximum Tolerated Dose of P-BCMA-101', 'timeFrame': 'Baseline through Day 28', 'description': 'Rate of dose limiting toxicities (DLT)'}, {'measure': 'Phase 2: Assess the Safety of P-BCMA-101', 'timeFrame': 'Baseline through 24 months', 'description': 'Incidence and severity of treatment-emergent adverse events'}, {'measure': 'Phase 2: Assess the Efficacy of P-BCMA-101 (ORR)', 'timeFrame': 'Baseline through 24 months', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nOverall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).'}, {'measure': 'Phase 2: Assess the Efficacy of P-BCMA-101 (DOR)', 'timeFrame': 'Baseline through 24 months', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nDuration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.'}], 'secondaryOutcomes': [{'measure': 'Phase 1:Assess the Safety of P-BCMA-101', 'timeFrame': 'Baseline through Month 24', 'description': 'Incidence and severity of treatment-emergent adverse events'}, {'measure': 'Phase 1:Assess the Feasibility P-BCMA-101', 'timeFrame': 'Baseline through Month 24', 'description': 'Ability to generate protocol-prescribed doses of P-BCMA-101.'}, {'measure': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (ORR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nOverall Response Rate (ORR)-Percentage of patients with complete response (CR), very good partial response (VGPR), or partial response (PR).'}, {'measure': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (TTR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nTime to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.'}, {'measure': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (DOR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nDuration of Response (DOR)-Time from complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.'}, {'measure': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (PFS)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nProgression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.'}, {'measure': 'Phase 1: Anti-myeloma Effect of P-BCMA-101 (OS)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nOverall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.'}, {'measure': 'Phase 1: The Effect of Cell Dose to Guide Selection of Doses for Further Assessment in Phase 2/3 Studies', 'timeFrame': 'Baseline through Month 24', 'description': 'Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)'}, {'measure': 'Phase 2: Incidence and Severity of Cytokine Release Syndrome (CRS)', 'timeFrame': 'Baseline through Month 24', 'description': 'Incidence and severity of CRS events graded using Lee criteria (Lee, 2014)'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (IL-6)', 'timeFrame': 'Baseline through Month 24', 'description': 'Rate of IL-6 antagonist'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (C)', 'timeFrame': 'Baseline through Month 24', 'description': 'Corticosteroid Use'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (R)', 'timeFrame': 'Baseline through Month 24', 'description': 'Rimiducid Use'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (OS)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nOverall Survival (OS)-Duration of survival from time of treatment with P-BCMA-101.'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (PFS)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nProgression Free Survival (PFS)-Time from P-BCMA-101 treatment to progressive disease.'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (TTR)', 'timeFrame': 'Baseline through Month 24', 'description': 'According to the International Myeloma Working Group (IMWG) Uniform Response Criteria for Multiple Myeloma:\n\nTime to Response (TTR)-Time to complete response (CR), very good partial response (VGPR), or partial response (PR) to progressive disease.'}, {'measure': 'Phase 2: Evaluate Efficacy Endpoints (MRD)', 'timeFrame': 'Baseline through Month 24', 'description': 'Minimum residual disease negative rate'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['CAR-T cells'], 'conditions': ['Multiple Myeloma']}, 'referencesModule': {'references': [{'pmid': '31215818', 'type': 'DERIVED', 'citation': 'Miah KM, Hyde SC, Gill DR. Emerging gene therapies for cystic fibrosis. Expert Rev Respir Med. 2019 Aug;13(8):709-725. doi: 10.1080/17476348.2019.1634547. Epub 2019 Jun 27.'}]}, 'descriptionModule': {'briefSummary': 'Phase 1 of the study is comprised of an open-label, single ascending dose (SAD), multiple cohort study; a multiple dose cycle administration cohort study; and a combination administration study of P-BCMA-101 autologous T stem cell memory (Tscm) CAR-T cells in patients with relapsed / refractory MM. Followed by a Phase 2, open-label, efficacy and safety study. Rimiducid may be administered as indicated.', 'detailedDescription': 'Phase 1 follows a 3 + 3 design of dose-escalating cohorts. Phase 2 of the study is an open-label multi-center efficacy and safety study. After a patient enrolls, leukapheresis will be performed to obtain peripheral blood mononuclear cells which will be sent to a manufacturing site to produce P-BCMA-101 CAR-T cells. The cells will then be returned to the investigational site and, after a standard chemotherapy based conditioning regimen, will be administered to the patient across 1-3 infusions, with or without combination therapy. Treated patients will undergo serial measurements of safety, tolerability and response. Rimiducid may be administered as indicated.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males or females, ≥18 years of age\n* Must have a confirmed diagnosis of active MM\n* Must have measurable MM\n* Must have relapsed / refractory MM, having received treatment with proteasome inhibitor and IMiD \\[Phase 2: Must have relapsed / refractory MM, and refractory to last line of therapy, having received treatment with proteasome inhibitor, an IMiD, CD38 targeted therapy and undergone autologous stem cell transplant (ASCT) or not a candidate for ASCT.\\]\n* Must have adequate hepatic, renal, cardiac and hematopoietic function\n\nExclusion Criteria:\n\n* Is pregnant or lactating\n* Has inadequate venous access and/or contraindications to leukapheresis\n* Has active hemolytic anemia, plasma cell leukemia, Waldenstrom's macroglobulinemia, POEMS syndrome, disseminated intravascular coagulation, leukostasis, amyloidosis, significant autoimmune, CNS or other malignant disease\n* Has an active second malignancy (not disease-free for at least 5 years) in addition to MM, excluding low-risk neoplasms such as non-metastatic basal cell or squamous cell skin carcinoma.\n* Has active autoimmune disease\n* Has a history of significant central nervous system (CNS) disease, such as stroke, epilepsy, etc.\n* Has an active systemic infection\n* Has hepatitis B or C virus, human immunodeficiency virus (HIV), or human T-lymphotropic virus (HTLV) infection, or any immunodeficiency syndrome.\n* Has any psychiatric or medical disorder that would preclude safe participation in and/or adherence to the protocol\n* Has receiving immunosuppressive or other contraindicated therapies within the excluded time frame from entry\n* Has CNS metastases or symptomatic CNS involvement\n* Has a history of having undergone allogeneic stem cell transplantation, or any other allogeneic or xenogeneic transplant, or has undergone autologous transplantation within 90 days.\n* Unable to take acetylsalicylic acid (ASA) daily as prophylactic anticoagulation. (Cohorts R and RP only).\n* History of thromboembolic disease within the past 6 months, regardless of anticoagulation (Cohorts R and RP only)."}, 'identificationModule': {'nctId': 'NCT03288493', 'briefTitle': 'P-BCMA-101 Tscm CAR-T Cells in the Treatment of Patients With Multiple Myeloma (MM)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Poseida Therapeutics, Inc.'}, 'officialTitle': 'Open-Label, Multicenter, Phase 1 Study to Assess the Safety of P BCMA-101 in Subjects With Relapsed / Refractory Multiple Myeloma (MM) Followed by a Phase 2 Assessment of Response and Safety (PRIME)', 'orgStudyIdInfo': {'id': 'P-BCMA-101-001'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Phase 1: P-BCMA-101 CAR-T cells', 'description': 'Single ascending dose cohorts, given in a single intravenous infusion of CAR-T cells. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells (Cohort A)', 'description': 'Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells (Cohort B)', 'description': 'Single dose given across three intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells (Cohort C)', 'description': 'Single dose given across two intravenous infusions of CAR-T cells. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before apheresis. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)', 'description': 'Single intravenous infusion of CAR-T cells, with combination therapy, beginning one week before CAR-T infusion. Rimiducid may be administered as indicated.', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}, {'type': 'EXPERIMENTAL', 'label': 'Phase 2: P-BCMA-101 CAR-T Cells', 'description': 'CAR-T cells administered via intravenous infusion as a total dose', 'interventionNames': ['Biological: P-BCMA-101 CAR-T cells', 'Drug: Rimiducid']}], 'interventions': [{'name': 'P-BCMA-101 CAR-T cells', 'type': 'BIOLOGICAL', 'description': 'P-BCMA-101 is an autologous, principally Tscm, CAR-T cell product (also called called a CARTyrin T cell product) targeting the myeloma selective protein BCMA. P-BCMA-101 cells are produced using a non-viral vector carrying the gene for an anti-BCMA Centyrin-based (small, fully human binding domain, designed to increase T cell persistence and decrease exhaustion) chimeric antigen receptor (CAR). Secondary to the large carrying capacity of the non-viral vector, P-BCMA-101 cells carry two additional genes, a selection gene used to manufacture a purified product and a "safety switch" gene to allow the cells to be eliminated if desired. Rimiducid (safety switch activator) may be administered as indicated.', 'armGroupLabels': ['Phase 1 P-BCMA-101 CAR-T cells (Cohort A)', 'Phase 1 P-BCMA-101 CAR-T cells (Cohort B)', 'Phase 1 P-BCMA-101 CAR-T cells (Cohort C)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)', 'Phase 1: P-BCMA-101 CAR-T cells', 'Phase 2: P-BCMA-101 CAR-T Cells']}, {'name': 'Rimiducid', 'type': 'DRUG', 'description': 'Rimiducid (safety switch activator) may be administered as indicated.', 'armGroupLabels': ['Phase 1 P-BCMA-101 CAR-T cells (Cohort A)', 'Phase 1 P-BCMA-101 CAR-T cells (Cohort B)', 'Phase 1 P-BCMA-101 CAR-T cells (Cohort C)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort R)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RIT)', 'Phase 1 P-BCMA-101 CAR-T cells with Comb.Therapy (Cohort RP)', 'Phase 1: P-BCMA-101 CAR-T cells', 'Phase 2: P-BCMA-101 CAR-T Cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85234', 'city': 'Gilbert', 'state': 'Arizona', 'country': 'United States', 'facility': 'Banner MD Anderson Cancer Center', 'geoPoint': {'lat': 33.35283, 'lon': -111.78903}}, {'zip': '95618', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '92093', 'city': 'San Diego', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego', 'geoPoint': {'lat': 32.71571, 'lon': -117.16472}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Francisco', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Cancer Center', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Greenebaum Comprehensive Cancer Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '21231', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'Johns Hopkins University', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '48201', 'city': 'Detroit', 'state': 'Michigan', 'country': 'United States', 'facility': 'Wayne State - Karmanos Cancer Institute', 'geoPoint': {'lat': 42.33143, 'lon': -83.04575}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37203', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Sarah Cannon Research Institute at Tennessee Oncology', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}, {'zip': '98104', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'Swedish Cancer Institute', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}], 'overallOfficials': [{'name': 'Rajesh Belani, M.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Sponsor Executive Medical Director'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Poseida Therapeutics, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'California Institute for Regenerative Medicine (CIRM)', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}