Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2025-12-26 @ 2:35 AM
Study NCT ID:
NCT07285694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-12-16
First Post:
2025-12-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011471', 'term': 'Prostatic Neoplasms'}, {'id': 'D009362', 'term': 'Neoplasm Metastasis'}], 'ancestors': [{'id': 'D005834', 'term': 'Genital Neoplasms, Male'}, {'id': 'D014565', 'term': 'Urogenital Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D005832', 'term': 'Genital Diseases, Male'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D011469', 'term': 'Prostatic Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D009385', 'term': 'Neoplastic Processes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 190}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-12', 'completionDateStruct': {'date': '2031-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-12-10', 'studyFirstSubmitDate': '2025-12-10', 'studyFirstSubmitQcDate': '2025-12-10', 'lastUpdatePostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-12-16', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2029-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Phase 1 (Dose escalation and Backfill Cohorts): incidence of adverse events', 'timeFrame': 'From AB-3028 infusion up to 24 months post-infusion', 'description': 'Defined as dose-limiting toxicities based on a Bayesian optimal interval (BOIN) design'}, {'measure': 'Phase 2 (Cohort expansion): Objective response rate (ORR)', 'timeFrame': 'From AB-3028 infusion up to 24 months post-infusion', 'description': 'ORR based on Independent Review Committee (IRC) assessment, defined as the proportion of subjects who have achieved a best overall response of CR or PR according to RECIST v1.1'}], 'primaryOutcomes': [{'measure': 'Safety and tolerability of AB-3028', 'timeFrame': 'From AB-3028 infusion up to 24 months post-infusion', 'description': 'To assess safety and tolerability of increasing dose levels of AB-3028 in successive cohorts of subjects with metastatic CRPC to determine the maximum tolerated dose (MTD) and/or recommended Phase 2 dose (RP2D) of AB-3028'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['prostate cancer', 'metastatic', 'Programmable circuit T cell', 'CRPC', 'AB-3028', 'autologous Cell Therapy', 'Cell Therapy', 'CAR T', 'castration resistant'], 'conditions': ['Metastatic Castration Resistant Prostate Cancer (mCRPC)']}, 'descriptionModule': {'briefSummary': 'This is a multi-center, open-label Phase 1/2 trial evaluating the safety and efficacy of AB-3028 in subjects with metastatic castration resistant prostate cancer (mCRPC).', 'detailedDescription': "This study is intended for subjects diagnosed with metastatic castration-resistant prostate cancer (mCRPC) and whose disease progressed after treatment with an androgen receptor pathway inhibitor (ARPI). The purpose of this study is to test the safety and efficacy of AB-3028 cells in subjects with metastatic castration-resistant prostate cancer. This treatment has not been approved by the Food and Drug Administration.\n\nThe goal of the Phase I portion of this study is to evaluate safety profile of AB-3028 and to determine the maximum tolerated dose or recommended phase 2 dose of AB-3028. The Phase 2 portion of the study will investigate the efficacy of AB-3028. T cells are part of the immune system that protect the body from infection and may help fight cancer. The T cells given in this study will come from the subject and will have a DNA cassette put in them that makes them able to recognize a priming antigen as well as Prostate-Specific Membrane Antigen (PSMA), two proteins found on prostate cancer tumor cells. These logic-gated T cells may help the body's immune system identify and kill cancer cells while sparing normal healthy tissues from toxicity.\n\nThe AB-3028 cells are given as a single intravenous infusion.\n\nAfter completion of study treatment, subjects are followed with serial measurements of safety, tolerability and response.\n\nThis is a research study to obtain new information that may help people in the future."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': False, 'eligibilityCriteria': 'Key Inclusion Criteria:\n\n1. At least 18 years of age at time of signing informed consent form.\n2. Histologically confirmed adenocarcinoma of the prostate, meeting all of the following criteria:\n\n • Documented progressive metastatic castration-resistant prostate cancer (mCRPC) based on PCWG3 criteria.\n3. Prior prostate cancer treatment with at least 1 novel androgen receptor pathway inhibitor (ARPI) therapy.\n\n • PSMA+ by PSMA PET.\n * Measurable disease by RECIST 1.1 criteria, or evaluable disease via measurable PSA (≥ 1 ng/mL) per PCWG3 criteria.\n4. Adequate organ functions.\n\nKey Exclusion Criteria:\n\n1. Any prior systemic therapy for CRPC within 14 days prior to scheduled protocol required leukapheresis.\n2. Central nervous system (CNS) metastatic disease, leptomeningeal disease, or cord compression.\n3. Unwillingness to participate in an extended safety monitoring period.'}, 'identificationModule': {'nctId': 'NCT07285694', 'briefTitle': 'AB-3028, a Programmable Circuit T Cell Therapy in Patients With Castration Resistant Prostate Cancer (CRPC)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Arsenal Biosciences, Inc.'}, 'officialTitle': 'An Open-label, Multicenter Phase 1/2 Study to Evaluate the Safety and Efficacy of AB-3028 in Patients With Castration Resistant Prostate Cancer (CRPC)', 'orgStudyIdInfo': {'id': 'AB-3028-201'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'AB-3028', 'description': 'Patients receive a single dose of AB-3028 intravenously on day 0.', 'interventionNames': ['Biological: AB-3028']}], 'interventions': [{'name': 'AB-3028', 'type': 'BIOLOGICAL', 'description': 'autologous T cell therapy', 'armGroupLabels': ['AB-3028']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Arsenal Biosciences, Inc.', 'role': 'CONTACT', 'email': 'clinicaltrials@arsenalbio.com', 'phone': '650-446-4874'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Arsenal Biosciences, Inc.', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}