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This is a first-in-human, single-arm, open-label study evaluating the safety, tolerability, and preliminary efficacy of ALLO-329 in adults with autoimmune diseases: systemic lupus erythematosus (SLE) with and without renal involvement, idiopathic inflammatory myopathy (IIM), and systemic sclerosis (SSc).The purpose of this trial is to evaluate the safety and tolerability of ALLO-329, an allogeneic anti-CD19, anti-CD70 dual chimeric antigen receptor (CAR) T cell therapy, in adults with autoimmune disorders, provide initial evidence of biological activity and clinical response to the treatment and determine the recommended Phase 2 regimen (RP2R).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ALLO-329, Cyclophosphamide | Experimental | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide. |
|
| ALLO-329 | Experimental | Participants receive ALLO-329 without a lymphodepletion regimen. |
|
| ALLO-329, Cyclophosphamide, Fludarabine | Experimental | Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ALLO-329 | Genetic | An allogeneic CAR T cell therapy targeting CD19 and CD70 |
|
| Measure | Description | Time Frame |
|---|---|---|
| Incidence of Dose Limiting toxicities (DLTs) and Other Safety Parameters | The incidence of dose limiting toxicities (DLTs) and other safety parameters (including but not limited to treatment emergent adverse events [AEs], serious adverse events [SAEs], and clinical laboratory abnormalities) | Up to 60 months |
| Measure | Description | Time Frame |
|---|---|---|
| Disease Response to Treatment - Systemic Lupus Erythematosus | Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission. | Up to 60 months |
| Disease Response to Treatment - Systemic Lupus Erythematosus |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Allogene Therapeutics, Inc. | Contact | +1 415-604-5696 | clinicaltrials@allogene.com |
| Name | Affiliation | Role |
|---|---|---|
| Allogene Study Director | Allogene Therapeutics, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic | Recruiting | Phoenix | Arizona | 85054 | United States |
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| Cyclophosphamide | Drug | Chemotherapy for lymphodepletion |
|
| Fludarabine | Drug | Chemotherapy for lymphodepletion |
|
Efficacy as assessed by change from baseline in SLEDAI-2K score.
| Up to 60 months |
| Disease Response to Treatment - Lupus Nephritis | Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR). | Up to 60 months |
| Disease Response to Treatment - Idiopathic Inflammatory Myopathy | Efficacy as assessed by ACR/EULAR myositis response criteria components. | Up to 60 months |
| Disease Response to Treatment - Systemic Sclerosis | Efficacy as assessed by change from baseline in the European Scleroderma Trials and Research Group (EUSTAR) activity index. | Up to 60 months |
| Disease Response to Treatment - Systemic Sclerosis | Efficacy as assessed by change from baseline in the American College of Rheumatology Composite Response Index in Diffuse Cutaneous Systemic Sclerosis (ACR-CRISS). | Up to 60 months |
| ALLO-329 Peak Expansion (Cmax) | Up to 60 months |
| ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC) | Up to 60 months |
| Loma Linda University Medical Center | Recruiting | Loma Linda | California | 92354 | United States |
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| University of Colorado Denver | Recruiting | Aurora | Colorado | 80045 | United States |
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| Mayo Clinic | Recruiting | Jacksonville | Florida | 32224 | United States |
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| The University of Chicago Medical Center | Recruiting | Chicago | Illinois | 60637 | United States |
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| University of Iowa | Recruiting | Iowa City | Iowa | 52242 | United States |
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| Norton Cancer Institute, St. Matthews Campus | Recruiting | Louisville | Kentucky | 40207 | United States |
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| Astera Cancer Care | Recruiting | East Brunswick | New Jersey | 08816 | United States |
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| Icahn School of Medicine at Mount Sinai | Recruiting | New York | New York | 10029 | United States |
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| Duke University Medical Center | Recruiting | Durham | North Carolina | 27710 | United States |
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| Medical University of South Carolina | Recruiting | Charleston | South Carolina | 29605 | United States |
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| Prisma Health | Recruiting | Greenville | South Carolina | 29425 | United States |
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| LDS Hospital - lntermountain Health | Recruiting | Salt Lake City | Utah | 84143 | United States |
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| Hôpital Maisonneuve Rosemont | Recruiting | Montreal | Quebec | H1T 2M4 | Canada |
|
| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| D009220 | Myositis |
| D012595 | Scleroderma, Systemic |
| D008181 | Lupus Nephritis |
| D003882 | Dermatomyositis |
| D045743 | Scleroderma, Diffuse |
| D001327 | Autoimmune Diseases |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D007154 | Immune System Diseases |
| D009135 | Muscular Diseases |
| D009140 | Musculoskeletal Diseases |
| D009468 | Neuromuscular Diseases |
| D009422 | Nervous System Diseases |
| D012871 | Skin Diseases |
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D017285 | Polymyositis |
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| ID | Term |
|---|---|
| D003520 | Cyclophosphamide |
| C024352 | fludarabine |
| ID | Term |
|---|---|
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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