Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-31 @ 9:48 PM
Study NCT ID:
NCT05850234
Status:
RECRUITING
Last Update Posted:
2025-08-06
First Post:
2023-04-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'GC012F (AZD0120) will be administrated in one infusion'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 80}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-07-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-08', 'completionDateStruct': {'date': '2028-11-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-05', 'studyFirstSubmitDate': '2023-04-18', 'studyFirstSubmitQcDate': '2023-04-28', 'lastUpdatePostDateStruct': {'date': '2025-08-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-05-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phase 1b Adverse Events (AEs)', 'timeFrame': '2 years', 'description': 'The incidence and severity of adverse events (AEs)'}, {'measure': 'Phase 1b Dose-limiting toxicities', 'timeFrame': '28 days', 'description': 'The DLT evaluation period is defined as the first 28 days of Cycle 1'}, {'measure': 'Phase 2 Overall response rate (ORR)', 'timeFrame': '2 years', 'description': 'Overall response rate (ORR) as defined by the International Myeloma Working Group (IMWG)'}], 'secondaryOutcomes': [{'measure': 'Phase 1b Pharmacokinetic - AUC', 'timeFrame': '2 years', 'description': 'Area under the curve of the GC012F (AZD0120) level'}, {'measure': 'Phase 1b Pharmacokinetic - Cmax', 'timeFrame': '2 years', 'description': 'Maximum GC012F (AZD0120) level'}, {'measure': 'Phase 1b Pharmacokinetic - half-life', 'timeFrame': '2 years', 'description': 'The elimination half-life of GC012F (AZD0120) level'}, {'measure': 'Phase 1b Pharmacokinetic - Tmax', 'timeFrame': '2 years', 'description': 'Time to reach Maximum GC012F (AZD0120) level'}, {'measure': 'Phase 2: Adverse Events (AEs)', 'timeFrame': '2 years', 'description': 'Further characterization of the safety of GC012F (AZD0120) by measuring the incidence and severity of AEs'}, {'measure': 'Phase 1b and 2: Overall Response Rate (ORR)', 'timeFrame': '2 years', 'description': 'ORR (sCR/CR/VGPR) is defined as the proportion of subjects who achieve sCR/CR/VGPR rate according to the IMWG criteria.'}, {'measure': 'Phase 1b and 2: MRD negative rate', 'timeFrame': '2 years', 'description': 'MRD negative rate as defined by the IMWG response criteria'}, {'measure': 'Phase 1b and 2: Duration of response (DOR)', 'timeFrame': '2 years', 'description': 'Duration of response (DOR) will be calculated among responders from the date of initial documentation of a response to the date of first documented evidence of progressive disease, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.'}, {'measure': 'Phase 1b and 2: PFS', 'timeFrame': '2 years', 'description': 'Progression-free survival (PFS) defined as the time from the date of the initial infusion of GC012F to the date of first documented disease progression, as defined in the IMWG criteria, or death due to any cause, whichever occurs first.'}, {'measure': 'Phase 1b and 2: OS', 'timeFrame': '2 years', 'description': "Overall survival (OS) is measured from the date of the initial infusion of GC012F to the date of the subject's death."}]}, 'oversightModule': {'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Multiple Myeloma, BCMA, CAR'], 'conditions': ['Relapsed/ Refractory Multiple Myeloma']}, 'descriptionModule': {'briefSummary': 'This trial is a phase 1b/2, open-label, multicenter study of GC012F (AZD0120), a CD19/BCMA dual CART-cell therapy, in adult subjects with relapsed/refractory Multiple Myeloma.', 'detailedDescription': 'For Phase Ib It aims to evaluate the safety, tolerability, pharmacokinetic characteristics, pharmacodynamic effect, immunogenicity in subjects with relapsed/ refractory Multiple Myeloma, and determine the recommended Phase 2 dose of GC012F (AZD0120).\n\nFor Phase 2, it aims to evaluate the efficacy, to further characterize the safety of GC012F (AZD0120), pharmacodynamic effect, and immunogenicity, changes from baseline for subject-reported health-related quality of life, overall health status in subjects with relapsed/ refractory Multiple Myeloma.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Males and females ≥18 years of age at the time of consent\n* Written informed consent in accordance with federal, local, and institutional guidelines\n* Have an ECOG performance status of 0 or 1\n* Documented diagnosis of MM per IMWG diagnostic criteria\n* Received at least three prior MM treatment lines of therapy\n* Have received as part of their previous therapy a PI and IMiD and an antiCD38 antibody.\n* Have documented evidence of progressive disease by the IMWG criteria.\n* Subjects must have measurable disease at screening, as defined by any of the following: serum monoclonal paraprotein (M-protein) ≥1.0g/dL (10 g/L); urine M-protein ≥200 mg/24 h; serum FLC assay: involved FLC level is ≥10 mg/dL (100 mg/L) and serum kappa lambda FLC ratio is abnormal.\n* Adequate bone marrow and organ function assessment at screening according to the hematological, hepatic, and renal parameters listed in the CSP\n\nExclusion Criteria :\n\n* Diagnosed or treated for invasive malignancy other than multiple myeloma, except: Malignancy treated with curative intent and with no known active disease present for ≥2 years before enrollment; or\n* Adequately treated non-melanoma skin cancer without evidence of disease.\n* The following cardiac conditions:\n* New York Heart Association (NYHA) stage III or IV congestive heart failure\n* Myocardial infarction or coronary artery bypass graft (CABG) ≤6 months prior to enrollment\n* History of clinically significant ventricular arrhythmia or unexplained syncope, not believed to be vasovagal in nature or due to dehydration\n* History of severe non-ischemic cardiomyopathy\n* Received either of the following:\n* An allogenic stem cell transplant within 6 months before apheresis. Subjects who received an allogeneic transplant must be off all immunosuppressive medications for 6 weeks without signs of graft-versus-host disease (GVHD).\n* An autologous stem cell transplant ≤12 weeks before apheresis\n* Known active, or prior history of central nervous system (CNS) involvement or exhibits clinical signs of meningeal involvement of multiple myeloma.\n* Plasma cell leukemia at the time of screening (\\>2.0×109 /L plasma cells by standard differential), Waldenström's macroglobulinemia, POEMS syndrome (polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes), or primary AL amyloidosis."}, 'identificationModule': {'nctId': 'NCT05850234', 'briefTitle': 'A Study of GC012F (AZD0120), a CAR T Therapy Targeting CD19 and BCMA in Subjects With Relapsed/Refractory Multiple Myeloma', 'organization': {'class': 'INDUSTRY', 'fullName': 'AstraZeneca'}, 'officialTitle': 'A Phase 1b/2 Study of GC012F (AZD0120), a Chimeric Antigen Receptor T-cell (CAR T) Therapy Targeting CD19 and B-cell Maturation Antigen (BCMA) in Subjects With Relapsed/Refractory Multiple Myeloma', 'orgStudyIdInfo': {'id': 'D8310C00001'}, 'secondaryIdInfos': [{'id': 'GC012F-CD19/BCMA-001', 'type': 'OTHER', 'domain': 'Gracell Biopharmaceuticals'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'GC012F (AZD0120)', 'description': 'GC012F (AZD0120) will be administrated in one infusion', 'interventionNames': ['Biological: GC012F (AZD0120)']}], 'interventions': [{'name': 'GC012F (AZD0120)', 'type': 'BIOLOGICAL', 'description': 'GC012F (AZD0120) is a BCMA/CD19 dual CAR product under investigation for the treatment of patients with RRMM.', 'armGroupLabels': ['GC012F (AZD0120)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35233', 'city': 'Birmingham', 'state': 'Alabama', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.52066, 'lon': -86.80249}}, {'zip': '85054', 'city': 'Phoenix', 'state': 'Arizona', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 33.44838, 'lon': -112.07404}}, {'zip': '92037', 'city': 'La Jolla', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 32.84727, 'lon': -117.2742}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94143', 'city': 'San Francisco', 'state': 'California', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 37.77493, 'lon': -122.41942}}, {'zip': '80045', 'city': 'Aurora', 'state': 'Colorado', 'status': 'NOT_YET_RECRUITING', 'country': 'United States', 'facility': 'Research Site', 'geoPoint': {'lat': 39.72943, 'lon': -104.83192}}, {'zip': '80218', 'city': 'Denver', 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For details of our timelines, please rerefer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.', 'ipdSharing': 'YES', 'description': 'Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.', 'accessCriteria': 'When a request has been approved AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org.\n\nSigned Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AstraZeneca', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}