Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-25 @ 9:38 PM
Study NCT ID:
NCT04650451
Status:
SUSPENDED
Last Update Posted:
2023-04-20
First Post:
2020-11-20
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2024-06-28', 'releaseDate': '2024-01-17'}], 'estimatedResultsFirstSubmitDate': '2024-01-17'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D001943', 'term': 'Breast Neoplasms'}, {'id': 'D013274', 'term': 'Stomach Neoplasms'}], 'ancestors': [{'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D001941', 'term': 'Breast Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D005770', 'term': 'Gastrointestinal Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D005767', 'term': 'Gastrointestinal Diseases'}, {'id': 'D013272', 'term': 'Stomach Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000076962', 'term': 'Receptors, Chimeric Antigen'}, {'id': 'D001336', 'term': 'Automobiles'}], 'ancestors': [{'id': 'D062165', 'term': 'Receptors, Artificial'}, {'id': 'D011956', 'term': 'Receptors, Cell Surface'}, {'id': 'D008565', 'term': 'Membrane Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D011948', 'term': 'Receptors, Antigen, T-Cell'}, {'id': 'D011946', 'term': 'Receptors, Antigen'}, {'id': 'D011971', 'term': 'Receptors, Immunologic'}, {'id': 'D018160', 'term': 'Receptors, Cytoplasmic and Nuclear'}, {'id': 'D018986', 'term': 'Motor Vehicles'}, {'id': 'D014186', 'term': 'Transportation'}, {'id': 'D013676', 'term': 'Technology, Industry, and Agriculture'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 220}}, 'statusModule': {'whyStopped': 'Due to a Dose Limiting Toxicity in another sister trial with same technology.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2020-12-07', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2027-01-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-04-18', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-12-01', 'lastUpdatePostDateStruct': {'date': '2023-04-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Proportion of subjects experiencing Dose Limiting Toxicities at increasing doses of BPX-603', 'timeFrame': '35 days from time of BPX-603 infusion', 'description': 'Dose limiting toxicities are defined as BPX-603-related adverse events.'}, {'measure': 'Maximum tolerated dose (MTD) and/or recommended dose for expansion (RDE)', 'timeFrame': 'through Phase 1 completion, up to 2 years', 'description': 'Identify the optimal dose of BPX-603 for Phase 2.'}], 'secondaryOutcomes': [{'measure': 'Persistence of HER2-CAR T cells (cell counts)', 'timeFrame': 'measured over time from baseline through study completion, up to 5 years', 'description': 'The persistence over time of BPX-603 CAR T cells in the peripheral blood as determined by flow cytometry (% CAR+ cells).'}, {'measure': 'Expansion of HER2-CAR T cells (vector copy number)', 'timeFrame': 'measured over time from baseline through study completion, up to 5 years', 'description': 'The expansion over time of BPX-603 CAR T cells in the peripheral blood as determined by qPCR (copies/ug gDNA).'}, {'measure': 'Antitumor activity of BPX-603', 'timeFrame': 'through study completion, up to 5 years', 'description': 'Overall response rate'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['HER2', 'CAR-T', 'breast cancer', 'solid tumors', 'gastric cancer'], 'conditions': ['HER-2 Gene Amplification', 'HER2-positive Gastric Cancer', 'HER2-positive Breast Cancer', 'HER-2 Protein Overexpression', 'Solid Tumor, Adult']}, 'descriptionModule': {'briefSummary': 'This is a Phase 1/2, open-label, multicenter, non-randomized study to investigate the safety, tolerability, and clinical activity of HER2-specific dual-switch CAR-T cells, BPX-603, administered with rimiducid to subjects with previously treated, locally advanced or metastatic solid tumors which are HER2 amplified/overexpressed.', 'detailedDescription': '* Phase 1: Cell dose escalation to identify the maximum dose of BPX-603 administered without or with rimiducid. The first subject in each dose cohort will receive BPX-603 alone (without rimiducid) in order to assess safety of the CAR-T monotherapy.\n* Phase 2: Indication-specific dose expansion to assess the safety, pharmacodynamics (including BPX-603 persistence and response to temsirolimus as applicable), and clinical activity at the recommended dose for expansion (RDE) identified in Phase 1 in various HER2+ solid tumors.\n* During Phase 1 or 2, temsirolimus (single IV dose at 25 mg) may be administered following BPX-603 infusion in response to treatment-emergent toxicity in order to activate the iRC9 safety switch.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Documented evidence of HER2 amplification/overexpression by local testing.\n* Histologically or cytologically confirmed diagnosis of a locally advanced unresectable or metastatic HER2+ solid tumor malignancy for which standard treatment is no longer effective, does not exist, or subject is ineligible.\n* Subjects with a solid tumor malignancy for which HER2-targeted therapy is approved as a standard treatment (e.g., breast, gastric cancers) must have received prior treatment with approved HER2-directed therapy.\n* Measurable disease (at least one target lesion) per RECIST v1.1.\n* Life expectancy \\> 12 weeks.\n* ECOG 0-1.\n* Adequate organ function.\n\nExclusion Criteria:\n\n* Symptomatic, untreated, or actively progressing central nervous system metastases.\n* Prior CAR T cell or other genetically-modified T cell therapy.\n* Impaired cardiac function or clinically significant cardiac disease.\n* Symptomatic intrinsic lung disease or those with extensive tumor involvement of the lungs.\n* Severe intercurrent infection.\n* Pregnant or breastfeeding.\n* Known HIV positivity.'}, 'identificationModule': {'nctId': 'NCT04650451', 'briefTitle': 'Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) in Subjects With HER2-Positive Solid Tumors', 'organization': {'class': 'INDUSTRY', 'fullName': 'Bellicum Pharmaceuticals'}, 'officialTitle': 'A Phase 1/2, Open-Label, Multicenter, Non-Randomized, Safety and Activity Study of HER2-Targeted Dual Switch CAR-T Cells (BPX-603) In Subjects With Previously Treated Advanced HER2-Positive Solid Tumors', 'orgStudyIdInfo': {'id': 'BPX603-201A'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'HER2-targeted dual-switch CAR-T cells', 'description': 'Subjects will receive one dose of BPX-603 on Day 1, followed by rimiducid IV infusion weekly (as tolerated) starting on Day 8 and continued until treatment discontinuation criteria are met.', 'interventionNames': ['Biological: chimeric antigen receptor (CAR) T cell therapy']}], 'interventions': [{'name': 'chimeric antigen receptor (CAR) T cell therapy', 'type': 'BIOLOGICAL', 'otherNames': ['CAR-T', 'BPX-603', 'autologous CAR-T'], 'description': 'HER2-targeted dual-switch CAR-T cells', 'armGroupLabels': ['HER2-targeted dual-switch CAR-T cells']}]}, 'contactsLocationsModule': {'locations': [{'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '92093', 'city': 'La Jolla', 'state': 'California', 'country': 'United States', 'facility': 'University of California San Diego (UCSD)', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '322972', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Winship Cancer Institute at Emory University', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '07601', 'city': 'Hackensack', 'state': 'New Jersey', 'country': 'United States', 'facility': 'John Theurer Cancer Center, Hackensack University Medical Center', 'geoPoint': {'lat': 40.88593, 'lon': -74.04347}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Cancer Institute', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '77030', 'city': 'Houston', 'state': 'Texas', 'country': 'United States', 'facility': 'The University of Texas MD Anderson Cancer Center', 'geoPoint': {'lat': 29.76328, 'lon': -95.36327}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Bellicum Pharmaceuticals', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2024-01-17', 'type': 'RELEASE'}, {'date': '2024-06-28', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Bellicum Pharmaceuticals'}}}}