Ignite Creation Date:
2025-12-24 @ 10:56 PM
Ignite Modification Date:
2025-12-25 @ 8:24 PM
Study NCT ID:
NCT06149169
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-08-21
First Post:
2023-11-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D012008', 'term': 'Recurrence'}], 'ancestors': [{'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008232', 'term': 'Lymphoproliferative Disorders'}, {'id': 'D008206', 'term': 'Lymphatic Diseases'}, {'id': 'D006425', 'term': 'Hemic and Lymphatic Diseases'}, {'id': 'D007160', 'term': 'Immunoproliferative Disorders'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2023-08-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2025-03-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-08-19', 'studyFirstSubmitDate': '2023-11-14', 'studyFirstSubmitQcDate': '2023-11-19', 'lastUpdatePostDateStruct': {'date': '2024-08-21', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Pharmacokinetic(PK)-Cmax of Relma-cel', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Maximum observed concentration of Relma-cel in peripheral blood'}, {'measure': 'Pharmacokinetic(PK)-Tmax of Relma-cel', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Time to maximum concentration of Relma-cel in peripheral blood'}, {'measure': 'Pharmacokinetic(PK)-AUC of Relma-cel', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Area under the concentration vs time curve of Relma-cel'}], 'secondaryOutcomes': [{'measure': 'Objective response rate (ORR) in LBCL subjects', 'timeFrame': '3 months', 'description': 'Objective response rate (ORR) in 3 month evaluated by investigator of LBCL subjects.'}, {'measure': 'Best objective response rate ( Best ORR) in LBCL subjects', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Best objective response rate (ORR) evaluated by the investigator of LBCL subjects.'}, {'measure': 'Complete response rate (CRR) in LBCL subjects', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Complete response rate (CRR) at any time points evaluated by the investigator.'}, {'measure': 'Adverse events (AEs)', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'These adverse events would be measured by assessment scale method according to NCI-CTCAE v4.03 classification standard.'}, {'measure': 'Duration of response (DOR)', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Time from first response (PR or CR) to disease progression or death from any cause.'}, {'measure': 'Progression-free survival (PFS)', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Progression-free survival'}, {'measure': 'Overall survival (OS)', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'Overall survival'}, {'measure': 'Changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'The changes of serum cytokines-IL-2，IL-6，IL-8 and IFN- γ after Relma-cel infusion.'}, {'measure': 'Changes of inflammation biomarker-CRP', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'The changes of inflammation biomarker-CRP after Relma-cel infusion.'}, {'measure': 'Changes of inflammation biomarker-serum ferritin', 'timeFrame': 'up to 1 year after Relma-cel infusion', 'description': 'The changes of inflammation biomarker-serum ferritin after Relma-cel infusion.'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['JWCAR029', 'B-Cell Malignancies', 'CAR T cells', 'Chimeric antigen receptor', 'Relapsed/Refractory'], 'conditions': ['Lymphoma, Non-Hodgkin', 'Diffuse Large B Cell Lymphoma']}, 'descriptionModule': {'briefSummary': 'This is an open-label, single-arm study to treat the adult R/R Large B-cell Lymphoma subjects with Relmacabtagene autoleucel (relma-cel) in China.', 'detailedDescription': 'This is an open-label, single-arm study conducted in adult subjects with R/R LBCL in China to evaluate the pharmacokinetics(PK), safety and efficacy of relma-cel, monitor the immune response after relma-cel treatment.\n\nRelma-cel was approved by the China National Medical Products Administration(NMPA)in September 2021(Acceptance No:CXSS2000036)for the treatment of adult patients with R/R LBCL after second-line or more systemic therapy.The recommended dose is 1×10\\^8 CAR+T cells.The indication for this application is R/R LBCL(supplement study) and the recommended dose is 1×10\\^8 CAR+T cells.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years old;\n2. Sign on the informed consent;\n3. Subjects must have histologically confirmed Large B-cell Lymphoma;\n4. Subjects had been treated with anthracyclines and rituximab(or other CD20-targeted antibodies) and had relapsed, failed to respond, or progressed after at least two lines of therapy include autologous hematopoietic stem cell transplantation(auto-HSCT);\n5. Subjects have accessible PET-positive lesion and have measurable CT-positive lesion according to Lugano Classification;\n6. Eastern Cooperative Oncology Group(ECOG) performance status of 0 or 1;\n7. Adequate organ function;\n8. Adequate vascular access for leukapheresis procedur;\n9. Subjects who have previously received CD19 targeted therapy must confirm that lymphoma lesions still expresss CD19;\n10. Women of childbearing potential must agree to use highly effective methods of contraception for 1 year after the last dose of Relma-cel;\n11. Males who have partners of childbearing potential must agree to use an effective barrier contraceptive method for 1 year after the last dose of Relma-cel.\n\nExclusion Criteria:\n\n1. Central nervous system(CNS) only involvement by malignancy or primary CNS lymphoma;\n2. History of another primary malignancyn that has not been in remission for at least 2 years;\n3. Subjects has HBV,HCV,HIV or syphilis nefection at the time of screening;\n4. Active deep venous thrombosis(DVT)/Pulmonary embolism(PE),or active DVT/PE requires anti-coagulation within 3 months prior to signing the ICF;\n5. Subjects with uncontrolled systemic fungal,bacterial,viral or other infection;\n6. Presence of acute or chronic graft-versus-host disease(GVHD);\n7. History of any serious cardiovascular disease or presence of clinically relevant CNS pathology;\n8. Pregnant or nursing woman;\n9. Subjects using of any chemotherapy,corticisteriod,experiment agents,GVHD therapies,radiation,allo-HSCT or any other therapies for lymphoma must go through a specific wash-out period before leukapheresis;\n10. Uncontrolled conditions or unwillingness or inability to follow the procedures required in the protocol;\n11. Received CAR T-cell or other genetically-modified T-cell therapy previously.'}, 'identificationModule': {'nctId': 'NCT06149169', 'briefTitle': 'CD19-targeted CAR T Cells for Relapsed and Refractory (R/R) Large B-cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'Shanghai Ming Ju Biotechnology Co., Ltd.'}, 'officialTitle': 'An Open-Label, Single-Arm Study of Relma-cel, CD19-targeted Chimeric Antigen Receptor (CAR)T Cells for Relapsed and Refractory (R/R) LBCL', 'orgStudyIdInfo': {'id': 'JWCAR029-017'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Relma-cel', 'description': 'The PK, safety and efficacy of Relma-cel will be evaluated in 1 x 10\\^8 CAR+T cells dose level', 'interventionNames': ['Biological: CD19-targeted Chimeric Antigen Receptor(CAR) T Cells']}], 'interventions': [{'name': 'CD19-targeted Chimeric Antigen Receptor(CAR) T Cells', 'type': 'BIOLOGICAL', 'description': 'Relma-cel be administered at one dose level:1×10\\^8 CAR+T cells', 'armGroupLabels': ['Relma-cel']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300060', 'city': 'Tianjin', 'state': 'Tianjin Municipality', 'country': 'China', 'facility': 'Tianjin Cancer Hospital', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}], 'overallOfficials': [{'name': 'Huilai Zhang', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Tianjin Cancer Hospital'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shanghai Ming Ju Biotechnology Co., Ltd.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}