Ignite Creation Date:
2025-12-25 @ 2:38 AM
Ignite Modification Date:
2025-12-26 @ 1:16 AM
Study NCT ID:
NCT05096234
Status:
TERMINATED
Last Update Posted:
2025-02-06
First Post:
2021-10-14
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008228', 'term': 'Lymphoma, Non-Hodgkin'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 2}}, 'statusModule': {'whyStopped': 'loss of sponsor support', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2021-09-28', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2023-10-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-03', 'studyFirstSubmitDate': '2021-10-14', 'studyFirstSubmitQcDate': '2021-10-14', 'lastUpdatePostDateStruct': {'date': '2025-02-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-10-27', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'First exploratory outcome measure', 'timeFrame': '≥ 3 months', 'description': 'correlation between changes in SUV \\[18F\\]F-AraG signal on PET imaging to the observed clinical benefit rate using RECISTv1.1 criteria.'}, {'measure': 'Second exploratory outcome measure', 'timeFrame': '≥ 3 months', 'description': 'Correlation between changes in \\[18F\\]F-AraG signal to the frequency and grade of two common CAR T cell toxicities, cytokine release syndrome (CRS) and neurotoxicity, if observed in this study population.'}], 'primaryOutcomes': [{'measure': 'Primary outcome measure', 'timeFrame': 'values obtained on Day 0 and Day 4 (± 2 days)', 'description': 'Spearman correlation between changes in SUV in \\[18F\\]F-AraG signal on PET imaging to changes in T-cell infiltrates in biopsy samples'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ["Non-Hodgkin's Lymphoma"]}, 'descriptionModule': {'briefSummary': 'This is a pilot study in adult subjects with aggressive B-cell lymphoma who will receive commercial or research CAR T cell therapy as anticancer treatment.', 'detailedDescription': 'Primary Objectives:\n\n\\* Explore the relationship of change in \\[18F\\]F-AraG PET signal following CAR T cell treatment with changes in T cell infiltration in tumor biopsies.\n\nExploratory Analyses:\n\n* Explore the relationship of change in \\[18F\\]F-AraG PET signal in tumor lesions following CAR T cell treatment with clinical benefit rate (defined as Complete Response (CR) + Partial Response (PR) + stable disease (SD) ≥ 3 months) using RECISTv1.1 criteria\n* Correlate the change in \\[18F\\]F-AraG PET signal in tumor lesions following CAR T cell therapy with maximum grade of Cytokine Release Syndrome (CRS) and neurotoxicity experienced.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age ≥ 18 years old\n* Histologically confirmed aggressive B cell NHL including the following types defined by WHO 2008:\n\n * DLBCL not otherwise specified; T cell/histiocyte rich large B cell lymphoma; DLBCL associated with chronic inflammation; Epstein Barr virus (EBV)+ DLBCL of the elderly; OR\n * primary mediastinal (thymic) large B cell lymphoma\n * transformation of follicular lymphoma, marginal zone lymphoma or chronic lymphocytic leukemia to DLBCL will also be included\n* Measurable disease by PET imaging (as defined by Cheson (2014)), that meets all the following criteria:\n\n * At least one measureable lesion away from head \\& neck, liver, kidneys, GI tract and bladder\n * At least one biopsy-accessible lesion or lymph node.\n* Express willingness to undergo low risk FNA or core biopsy of subcutaneous accessible lesion or lymph node.\n* Scheduled to receive commercial or research CAR T cell therapy with axicabtagene ciloleucel (Yescarta ®) as part of anticancer therapy.\n* Adequate renal and hepatic function, defined as:\n\n 1. Creatinine clearance (as estimated by Cockcroft Gault) ≥ 60 mL/min or Cr \\< 1.6 mg/dL\n 2. Serum alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤ 2.5x upper limit of normal (ULN)\n 3. Total bilirubin ≤ 1.5 mg/dL, except in cases of Gilbert's syndrome\n* Able to give informed consent. Subjects unable to give informed consent will not be eligible for this study\n\nExclusion Criteria:\n\n* Women who are pregnant or breastfeeding.\n* Subjects with significant GI disease involvement by PET imaging\n* In the investigator's judgment, have any medical condition likely to interfere with assessment of safety or efficacy, be unable to tolerate additional radiation, or be unlikely to complete all protocol-required visits and procedures."}, 'identificationModule': {'nctId': 'NCT05096234', 'briefTitle': '18F-F-AraG PET Imaging to Evaluate Immunological Response to CAR T Cell Therapy in Lymphoma', 'organization': {'class': 'OTHER', 'fullName': 'Stanford University'}, 'officialTitle': 'Pilot Study of [18F]F-AraG PET Imaging to Evaluate Immunological Response to Chimeric Antigen Receptor (CAR) T Cell Therapy in Lymphoma', 'orgStudyIdInfo': {'id': 'IRB-56655'}, 'secondaryIdInfos': [{'id': 'CCT5038', 'type': 'OTHER', 'domain': 'OnCore'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': '[18F]F-AraG PET', 'description': 'Subjects will undergo PET imaging at the following time points:\n\n* Baseline, prior to lymphodepleting chemotherapy: \\[18F\\]F-AraGPET/CT, followed the next day by FDG-PET/CT\n* At peak CAR expansion: Day 4 (± 2 days) post-CAR infusion:\n\n \\[18F\\]F-AraG PET\n* At Day +28 (± 4 days) post-CAR infusion: FDG-PET/CT Subjects will have a paired biopsy after each imaging time point, if possible. Subjects will be followed for safety of \\[18F\\]F-AraG for 30 days after last dose', 'interventionNames': ['Drug: [ 18F]F-AraG PET']}], 'interventions': [{'name': '[ 18F]F-AraG PET', 'type': 'DRUG', 'otherNames': ["[ 18F]F-AraG (2'-deoxy-2'-fluoro-9-β-D- arabinofuranosylguanine; trade name VisAcT)"], 'description': 'Dose: 5 mCi (±10%) Mode of Administration: Intravenous (IV)', 'armGroupLabels': ['[18F]F-AraG PET']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94305', 'city': 'Stanford', 'state': 'California', 'country': 'United States', 'facility': 'Stanford University, School of Medicine', 'geoPoint': {'lat': 37.42411, 'lon': -122.16608}}], 'overallOfficials': [{'name': 'David Miklos, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Stanford University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Stanford University', 'class': 'OTHER'}, 'collaborators': [{'name': 'CellSight Technologies, Inc.', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}