Ignite Creation Date:
2025-12-25 @ 4:14 AM
Ignite Modification Date:
2025-12-26 @ 3:13 AM
Study NCT ID:
NCT05972720
Status:
TERMINATED
Last Update Posted:
2025-05-15
First Post:
2023-07-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D012008', 'term': 'Recurrence'}, {'id': 'D008223', 'term': 'Lymphoma'}, {'id': 'D016393', 'term': 'Lymphoma, B-Cell'}, {'id': 'D016403', 'term': 'Lymphoma, Large B-Cell, Diffuse'}, {'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], 'ancestors': [{'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}, {'id': 'D015507', 'term': 'Drugs, Investigational'}], 'ancestors': [{'id': 'D010752', 'term': 'Phosphoramide Mustards'}, {'id': 'D009588', 'term': 'Nitrogen Mustard Compounds'}, {'id': 'D009150', 'term': 'Mustard Compounds'}, {'id': 'D006846', 'term': 'Hydrocarbons, Halogenated'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D063088', 'term': 'Phosphoramides'}, {'id': 'D009943', 'term': 'Organophosphorus Compounds'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 101}}, 'statusModule': {'whyStopped': 'Company decision to stop trial, withdraw the IND and close down operations.', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2023-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-05', 'completionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-05-13', 'studyFirstSubmitDate': '2023-07-25', 'studyFirstSubmitQcDate': '2023-07-25', 'lastUpdatePostDateStruct': {'date': '2025-05-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-08-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Objective response rate - Blinded independent review', 'timeFrame': 'Up to 24 months', 'description': 'Percentage of patients with complete or partial response determined by a blinded independent review committee'}], 'secondaryOutcomes': [{'measure': 'Objective response rate - Investigator assessment', 'timeFrame': 'Up to 24-months', 'description': 'Percentage of patients with complete or partial response determined by the investigator'}, {'measure': 'Complete response rate', 'timeFrame': 'Up to 24-months', 'description': 'Percentage of patients who achieve a Complete Response determined by independent review committee and investigators assessment'}, {'measure': 'Duration of response', 'timeFrame': 'Up to 24-months', 'description': 'Duration of response (the time from the date of the first occurrence of complete response or partial response to the date of progression, relapse, or death from any cause) determined by independent review committee and investigators'}, {'measure': 'Duration of complete response', 'timeFrame': 'Up to 24-months', 'description': 'Time from the date of the first occurrence of CR to the date of progression, relapse, or death from any cause determined by independent review committee and investigators.'}, {'measure': 'Progression-free survival', 'timeFrame': 'Up to 24-months', 'description': 'Progression-free survival (the time from CRG-022 infusion until the first occurrence of disease progression or relapse) determined by independent review committee and investigator assessment'}, {'measure': 'Overall Survival', 'timeFrame': 'Up to 24-months', 'description': 'Overall Survival (the period from the date of CRG-022 infusion until the date of death from any cause) documented by the Investigator.'}, {'measure': 'Incidence rate of adverse events', 'timeFrame': 'From Screening up to 15 years at protocol-defined timepoints', 'description': 'Percentage of patients with treatment-related adverse events is assessed by CTCAEv5.0, CRS, ICANS, and IEC-HS graded by ASTCT criteria.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Lymphoma', 'CD-22 Expressing Tumor', 'Chimeric Antigen Receptor', 'Adoptive Immunotherapy', 'Lymphoma, B-Cell', 'Lymphoma, Large B-Cell, Diffuse', 'Lymphoma, Primary Mediastinal B-cell', 'Lymphoma, Transformed', 'Lymphoma, Transformed Non-Hodgkin', 'Lymphoma, Non-Hodgkin', 'CAR T', 'CAR T-cell therapy', 'Cell Therapy', 'Cellular Immuno-therapy', 'CRG-022', 'CD22', 'FIRCE-1', 'firicabtagene autoleucel', 'firi-cel'], 'conditions': ['Cancer', 'Relapsed/Refractory Large B-cell Lymphoma (LBCL)']}, 'descriptionModule': {'briefSummary': 'This is a prospective, open-label, multi-center clinical study designed to evaluate the safety, tolerability, efficacy, pharmacokinetics, pharmacodynamics, and immunogenicity of firicabtagene autoleucel (firi-cel), a CD22-directed autologous Chimeric Antigen Receptor (CAR) T-cell therapy for the treatment of relapsed or refractory large B-cell lymphoma (LBCL).', 'detailedDescription': 'Firicabtagene autoleucel (firi-cel) is an autologous CAR T-cell therapy targeting CD22, a common B-cell antigen widely expressed in LBCL. This Phase 2 study is designed to evaluate the safety and the efficacy of firi-cel in patients with R/R LBCL that has progressed after CD19-directed CAR T-cell therapy. The study is designed to treat up to 123 patients with a single infusion of firi-cel.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n* Aged ≥18 years\n* Relapsed or refractory, histologically confirmed large B-cell lymphoma.\n* Must have relapsed or refractory diseae after last therapy.\n* For enrollment in cohort 1, patients must have previously received a CD19-directed CAR T-cell therapy\n* For enrollment in cohort 3, patients must have received at least two prior lines of therapy including a bispecific T-cel engaging antibody therapy.\n* Must have at least one radiographically measurable lesion.\n* Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1\n* Adequate hematological, renal, and liver function\n* Willing and able to remain within 1 hour of the treating center for at least 4 weeks after infusion.\n\nKey Exclusion Criteria:\n\n* Clinically significant concurrent medical illness\n* Active fungal, bacterial, viral or other infection.\n* Prior allogeneic stem cell transplant or allogeneic cell therapy\n\nNote: Other protocol defined Inclusion/Exclusion criteria may apply.'}, 'identificationModule': {'nctId': 'NCT05972720', 'acronym': 'FIRCE-1', 'briefTitle': 'A Phase 2 Study of Firi-cel in Patients With Relapsed/Refractory Large B-cell Lymphoma', 'organization': {'class': 'INDUSTRY', 'fullName': 'CARGO Therapeutics'}, 'officialTitle': 'An Open-label, Multicenter Phase 2 Study Evaluating the Efficacy and Safety of Firi-cel, a CD22-directed Autologous Chimeric Antigen Receptor (CAR) T-cell Therapy in Patients With Relapsed/Refractory Large B-Cell Lymphoma After CD19-directed CAR T-cell Therapy', 'orgStudyIdInfo': {'id': 'CRG-022-101'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental Drug (Cohort 1)', 'description': 'Single infusion of firi-cel following conditioning chemotherapy', 'interventionNames': ['Drug: Fludarabine (Conditional therapy)', 'Drug: Cyclophosphamide Monohydrate (Conditional therapy)', 'Drug: firi-cel (Experimental drug)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Drug (Cohort 2: non-conforming product)', 'description': 'Single infusion of firi-cel following conditioning chemotherapy (patients in this cohort will receive non-conforming firi-cel that is deemed safe to administer).', 'interventionNames': ['Drug: Fludarabine (Conditional therapy)', 'Drug: Cyclophosphamide Monohydrate (Conditional therapy)', 'Drug: firi-cel (Experimental drug)']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Drug (Cohort 3)', 'description': 'Patients with relapsed or refractory Large B-cell lymphoma who have previously been treated with bispecific T-cell engaging antibody therapy will receive a single infusion of firi-cel following conditioning chemotherapy.', 'interventionNames': ['Drug: Fludarabine (Conditional therapy)', 'Drug: Cyclophosphamide Monohydrate (Conditional therapy)', 'Drug: firi-cel (Experimental drug)']}], 'interventions': [{'name': 'Fludarabine (Conditional therapy)', 'type': 'DRUG', 'description': 'Lymphodepletion chemotherapy', 'armGroupLabels': ['Experimental Drug (Cohort 1)', 'Experimental Drug (Cohort 2: non-conforming product)', 'Experimental Drug (Cohort 3)']}, {'name': 'Cyclophosphamide Monohydrate (Conditional therapy)', 'type': 'DRUG', 'description': 'Lymphodepletion chemotherapy', 'armGroupLabels': ['Experimental Drug (Cohort 1)', 'Experimental Drug (Cohort 2: non-conforming product)', 'Experimental Drug (Cohort 3)']}, {'name': 'firi-cel (Experimental drug)', 'type': 'DRUG', 'description': 'Investigational agent', 'armGroupLabels': ['Experimental Drug (Cohort 1)', 'Experimental Drug (Cohort 2: non-conforming product)', 'Experimental Drug (Cohort 3)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72205', 'city': 'Little Rock', 'state': 'Arkansas', 'country': 'United States', 'facility': 'University of Arkansas Medical Sciences', 'geoPoint': {'lat': 34.74648, 'lon': -92.28959}}, {'zip': '91010', 'city': 'Duarte', 'state': 'California', 'country': 'United States', 'facility': 'City of Hope National Medical Center', 'geoPoint': {'lat': 34.13945, 'lon': -117.97729}}, {'zip': '90095', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': 'UCLA Division of Hematology Oncology', 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University Hospital and Clinics', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}, {'zip': '80218', 'city': 'Denver', 'state': 'Colorado', 'country': 'United States', 'facility': 'Colorado Blood Cancer Institute', 'geoPoint': {'lat': 39.73915, 'lon': -104.9847}}, {'zip': '06511', 'city': 'New Haven', 'state': 'Connecticut', 'country': 'United States', 'facility': 'Yale University', 'geoPoint': {'lat': 41.30815, 'lon': -72.92816}}, {'zip': '33136', 'city': 'Miami', 'state': 'Florida', 'country': 'United States', 'facility': 'University of Miami Hospital Sylvester Comprehensive Cancer Center', 'geoPoint': {'lat': 25.77427, 'lon': -80.19366}}, {'zip': '33612-941', 'city': 'Tampa', 'state': 'Florida', 'country': 'United States', 'facility': 'H. Lee Moffitt Cancer Center and Research Institute', 'geoPoint': {'lat': 27.94752, 'lon': -82.45843}}, {'zip': '30342', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': 'Northside Hospital', 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}, {'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Robert H. Lurie Comprehensive Cancer Center of Northwestern University', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '60637', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Chicago Medical Center', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '52242', 'city': 'Iowa City', 'state': 'Iowa', 'country': 'United States', 'facility': 'University of Iowa Hopitals & Clinics', 'geoPoint': {'lat': 41.66113, 'lon': -91.53017}}, {'zip': '66205', 'city': 'Westwood', 'state': 'Kansas', 'country': 'United States', 'facility': 'University of Kansas Medical Center Research Institute, Inc', 'geoPoint': {'lat': 39.04056, 'lon': -94.6169}}, {'zip': '21201', 'city': 'Baltimore', 'state': 'Maryland', 'country': 'United States', 'facility': 'University of Maryland Medical Center', 'geoPoint': {'lat': 39.29038, 'lon': -76.61219}}, {'zip': '20892', 'city': 'Bethesda', 'state': 'Maryland', 'country': 'United States', 'facility': 'National Cancer Institute', 'geoPoint': {'lat': 38.98067, 'lon': -77.10026}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Beth Israel Deaconess Medical Center', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '02215', 'city': 'Boston', 'state': 'Massachusetts', 'country': 'United States', 'facility': 'Dana-Farber Cancer Institute', 'geoPoint': {'lat': 42.35843, 'lon': -71.05977}}, {'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan Rogel Cancer Center', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}, {'zip': '63110', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Washington University School of Medicine in St. Louis', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'country': 'United States', 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}, {'zip': '10016', 'city': 'New York', 'state': 'New York', 'country': 'United States', 'facility': 'New York University Medical Center', 'geoPoint': {'lat': 40.71427, 'lon': -74.00597}}, {'zip': '44195', 'city': 'Cleveland', 'state': 'Ohio', 'country': 'United States', 'facility': 'Cleveland Clinic Foundation', 'geoPoint': {'lat': 41.4995, 'lon': -81.69541}}, {'zip': '43210', 'city': 'Columbus', 'state': 'Ohio', 'country': 'United States', 'facility': 'The Ohio State University Comprehensive Cancer Center', 'geoPoint': {'lat': 39.96118, 'lon': -82.99879}}, {'zip': '19104', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'University of Pennsylvania', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '19107', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Thomas Jefferson University', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '37232', 'city': 'Nashville', 'state': 'Tennessee', 'country': 'United States', 'facility': 'Vanderbilt University Medical Center', 'geoPoint': {'lat': 36.16589, 'lon': -86.78444}}, {'zip': '75390-9020', 'city': 'Dallas', 'state': 'Texas', 'country': 'United States', 'facility': 'UT Southwestern Medical Center', 'geoPoint': {'lat': 32.78306, 'lon': -96.80667}}, {'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 Medical Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '98109', 'city': 'Seattle', 'state': 'Washington', 'country': 'United States', 'facility': 'UW-Fred Hutchinson Cancer Center', 'geoPoint': {'lat': 47.60621, 'lon': -122.33207}}, {'zip': '53226-1222', 'city': 'Milwaukee', 'state': 'Wisconsin', 'country': 'United States', 'facility': 'Medical College of Wisconsin', 'geoPoint': {'lat': 43.0389, 'lon': -87.90647}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'CARGO Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}