Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:17 PM
Study NCT ID:
NCT06375993
Status:
RECRUITING
Last Update Posted:
2025-08-12
First Post:
2024-04-17
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Phase 1 Study of ADI-001 in Autoimmune Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D008181', 'term': 'Lupus Nephritis'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D012595', 'term': 'Scleroderma, Systemic'}, {'id': 'D008180', 'term': 'Lupus Erythematosus, Systemic'}, {'id': 'D056648', 'term': 'Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis'}, {'id': 'D009220', 'term': 'Myositis'}, {'id': 'D016750', 'term': 'Stiff-Person Syndrome'}], 'ancestors': [{'id': 'D005921', 'term': 'Glomerulonephritis'}, {'id': 'D009393', 'term': 'Nephritis'}, {'id': 'D007674', 'term': 'Kidney Diseases'}, {'id': 'D014570', 'term': 'Urologic Diseases'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D052801', 'term': 'Male Urogenital Diseases'}, {'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D056647', 'term': 'Systemic Vasculitis'}, {'id': 'D014657', 'term': 'Vasculitis'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D017445', 'term': 'Skin Diseases, Vascular'}, {'id': 'D009135', 'term': 'Muscular Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D009468', 'term': 'Neuromuscular Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D020274', 'term': 'Autoimmune Diseases of the Nervous System'}, {'id': 'D013118', 'term': 'Spinal Cord Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C024352', 'term': 'fludarabine'}, {'id': 'D003520', 'term': 'Cyclophosphamide'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL', 'interventionModelDescription': '3+3 Dose Escalation Design'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 180}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-11-10', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2027-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-07', 'studyFirstSubmitDate': '2024-04-17', 'studyFirstSubmitQcDate': '2024-04-17', 'lastUpdatePostDateStruct': {'date': '2025-08-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort', 'timeFrame': '28 Days', 'description': 'This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)'}, {'measure': 'Proportion of treatment emergent and treatment related adverse events', 'timeFrame': '2 year', 'description': 'This primary endpoint will be used to determine the MTD/MAD of ADI-001'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Lupus Nephritis', 'Autoimmune Diseases', 'Systemic Sclerosis (SSc)', 'Systemic Lupus Erythematosus (SLE)', 'ANCA-Associated Vasculitis (AAV)', 'Idiopathic Inflammatory Myopathies', 'Stiff Person Syndrome']}, 'descriptionModule': {'briefSummary': 'ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\nFor Cohort 1: Subjects with LN:\n\n1. Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019)\n2. Active kidney disease with biopsy-proven active LN Class III or IV (coexistent class V permitted) (per 2018 International Society of Nephrology \\[ISN\\]/Renal Pathology Society \\[RPS\\] criteria); biopsy should be performed within 6 months before enrolling in the study\n3. ECOG performance ≤ 2\n4. Proteinuria (or urine protein creatinine ratio \\[UPCR\\]) \\> 1g / 24 hours\n\nFor Cohort 1: Subjects with SLE with Extrarenal Involvement\n\n1. Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019).\n2. Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 with a clinical SLEDAI-2K score (SLEDAI-2K not including points for anti-dsDNA and/or low complement) ≥ 6 and/or ≥ 1 British Isles Lupus Assessment Group (BILAG)-2004 Category A\n3. Positive anti-nuclear antibody (ANA) test results and/or a positive anti-dsDNA and/or anti-Smith antibodies above the ULN\n4. Estimated creatinine clearance ≥ 60 mL/min\n5. Inadequate response in terms of active disease despite treatment with current standard of care for SLE including corticosteroids and at least 2 SLE therapy\n\nFor Cohort 2: Subjects with SSc\n\n1. Disease duration ≤ 6 years (from onset of first non-Raynaud manifestation)\n2. Participants with diffuse cutaneous SSc with worsening skin disease, must meet both of the following criteria: mRSS ≥ 15 at screening AND one of the following within 6 months prior to screening: (i) mRSS increase of ≥ 3 units in the total mRSS, OR (ii) Involvement of 1 new body area, OR (iii) Increase in mRSS ≥ 2 units in 1 body area\n3. Participants with diffuse or limited cutaneous SSc and ILD must meet both of the following criteria: ILD, i.e. fibrosis on HRCT within 4 months of screening AND Progression of ILD by FVC or HRCT in previous 24 months\n4. FVC ≥ 45% predicted, DLCO ≥ 40%\n5. Exclude PAH defined as RVSP ≥ 45 mmHg or right atrial or ventricular enlargement or dilatation, or renal crisis within 1 year of enrollment\n\nFor Cohort 3: Subjects with AAV\n\n1. Diagnosis of AAV defined as either GPA or MPA according to the 2012 Chapel Hill Consensus Conference\n2. Positive for PR3-ANCA or MPO-ANCA\n3. Relapsed or refractory AAV after at least 1 standard-of-care immunosuppressive regimen in addition to steroids.\n4. Severe disease (i.e., presence of one or more major AAV sign or symptom per the BVAS or ≥ 3 minor items, or at least the 2 renal items of proteinuria and hematuria due to vasculitis)\n5. Adequate renal function: CrCl ≥ 30 mL/min\n6. Proteinuria ≤ 8 g/24 hour\n\nFor Cohort 4: Subjects with Idiopathic Inflammatory Myopathies\n\n1. Meets the 2017 ACR/EULAR classification criteria (Lundberg 2017) for probable/definite IIM\n2. Muscle weakness defined as Manual Muscle Testing (MMT)-8 score \\< 142/150, and ≥ 2 of the following abnormal core set measures: (i) Patient global assessment VAS ≥ 2 cm (on 10-cm VAS), (ii) Physician global assessment VAS ≥ 2 cm (10-cm VAS), (iii) HAQ-DI \\> 0.25 , (iv) Extra-muscular global activity VAS ≥ 2 cm (10-cm VAS)\n3. Active disease defined as ≥ 1 of the following signs in the past 4 months: a) Elevated serum CK or aldolase levels ≥ 3 times ULN; b) Active myositis by muscle biopsy, muscle MRI, or EMG; c) Active DM rash and CDASI \\>14; d) Active interstitial lung disease\n4. Positivity for ≥ 1 myositis-specific antibody or myositis-associated antibody at screening\n5. Inadequate response or intolerance/contraindication to glucocorticoids and to ≥ 2 immunosuppressants for 3 months/drug\n\nFor Cohort 4: Subjects with Stiff Person Syndrome\n\n1. Meets the 2009 criteria for diagnosis of stiff person syndrome (SPS) (Dalakas 2009): (a) Stiffness of the axial muscles, particularly the abdominal and thoraco-lumbar paraspinals, leading to hyperlordosis; (b) Superimposed painful spasms triggered by unexpected tactile or auditory stimuli; (c) Severe anxiety with task-specific phobias especially in anticipation of physically challenging tasks; (d) Electromyographic evidence of continuous motor unit activity of agonist and antagonist muscles; (e) Absence of other neurological findings that may suggest an alternative diagnosis; (f) Highly positive anti-GAD titer (\\> 10,000 IU/mL in serum by ELISA or detectable in CSF)\n2. Inadequate response or intolerance or contraindication to ≥ 1 treatment including chronic IVIG or other biologic\n\nExclusion Criteria:\n\nFor all Subjects:\n\n1. Presence of severe liver disease, Child-Pugh class B or C.\n2. Prior treatment with any gene therapy, genetically modified cell therapy, or adoptive T cell therapy.\n3. Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).\n4. Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)\n5. History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.'}, 'identificationModule': {'nctId': 'NCT06375993', 'briefTitle': 'A Phase 1 Study of ADI-001 in Autoimmune Disease', 'organization': {'class': 'INDUSTRY', 'fullName': 'Adicet Therapeutics'}, 'officialTitle': 'A Phase 1 Study of ADI-001 Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Autoimmune Disease', 'orgStudyIdInfo': {'id': 'ADI-202300103'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'ADI-001 Dose Escalation', 'description': 'ADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001.', 'interventionNames': ['Drug: ADI-001', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'ADI-001 Dose Extension', 'description': 'After dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001.', 'interventionNames': ['Drug: ADI-001', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}, {'type': 'EXPERIMENTAL', 'label': 'ADI-001 Dose Expansion', 'description': 'Dose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).', 'interventionNames': ['Drug: ADI-001', 'Drug: Fludarabine', 'Drug: Cyclophosphamide']}], 'interventions': [{'name': 'ADI-001', 'type': 'DRUG', 'description': 'Anti-CD20 CAR-T', 'armGroupLabels': ['ADI-001 Dose Escalation', 'ADI-001 Dose Expansion', 'ADI-001 Dose Extension']}, {'name': 'Fludarabine', 'type': 'DRUG', 'description': 'Chemotherapy for Lymphodepletion', 'armGroupLabels': ['ADI-001 Dose Escalation', 'ADI-001 Dose Expansion', 'ADI-001 Dose Extension']}, {'name': 'Cyclophosphamide', 'type': 'DRUG', 'description': 'Chemotherapy for Lymphodepletion', 'armGroupLabels': ['ADI-001 Dose Escalation', 'ADI-001 Dose Expansion', 'ADI-001 Dose Extension']}]}, 'contactsLocationsModule': {'locations': [{'zip': '94065', 'city': 'Redwood City', 'state': 'California', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Adicet Clinical Trials', 'role': 'CONTACT', 'email': 'clinicaltrials@adicetbio.com', 'phone': '650-503-9095'}], 'facility': 'Adicet Clinical Trials', 'geoPoint': {'lat': 37.48522, 'lon': -122.23635}}, {'zip': '14263', 'city': 'Buffalo', 'state': 'New York', 'status': 'RECRUITING', 'country': 'United States', 'contacts': [{'name': 'Clinical Research Coordinator', 'role': 'CONTACT', 'email': 'Laura.Ryan@RoswellPark.org', 'phone': '716-845-3057'}], 'facility': 'Roswell Park Comprehensive Cancer Center', 'geoPoint': {'lat': 42.88645, 'lon': -78.87837}}], 'centralContacts': [{'name': 'Adicet Medical Director', 'role': 'CONTACT', 'email': 'clinicaltrials@adicetbio.com', 'phone': '650-503-9095'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Adicet Therapeutics', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}