A Phase 1 interventional study of ALLO-329 and Cyclophosphamide in Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy and Systemic Sclerosis, sponsored by Allogene Therapeutics. Recruiting at 17 sites in 2 countries. Open to participants aged 18 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-09-10.
Sponsored by Allogene Therapeutics · Phase 1, Interventional, and Treatment
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).
Exclusion Criteria:
Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide.
Genetic: ALLO-329 · Drug: Cyclophosphamide
Participants receive ALLO-329 without a lymphodepletion regimen.
Genetic: ALLO-329
Participants receive ALLO-329 following lymphodepletion regimen comprised of cyclophosphamide and fludarabine.
Genetic: ALLO-329 · Drug: Cyclophosphamide · Drug: Fludarabine
An allogeneic CAR T cell therapy targeting CD19 and CD70
Chemotherapy for lymphodepletion
Chemotherapy for lymphodepletion
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)
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by rates of achieving SRI-4, LLDAS and DORIS remission.
Time frame: Up to 60 months
Disease Response to Treatment - Systemic Lupus Erythematosus
Efficacy as assessed by change from baseline in SLEDAI-2K score.
Time frame: Up to 60 months
Disease Response to Treatment - Lupus Nephritis
Efficacy as assessed by complete renal response (CRR) and partial renal response (PRR).
Time frame: Up to 60 months
Disease Response to Treatment - Idiopathic Inflammatory Myopathy
Efficacy as assessed by ACR/EULAR myositis response criteria components.
Time frame: 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.
Time frame: 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).
Time frame: Up to 60 months
ALLO-329 Peak Expansion (Cmax)
Time frame: Up to 60 months
ALLO-329 Persistence Over Time Including Area Under the Expansion Curve (AUC)
Time frame: Up to 60 months
Plan to share: No
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Lupus Erythematosus, Systemic→
Allogene Therapeutics