Trials / Recruiting
RecruitingNCT07085104
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
A Phase 1 Study Evaluating the Safety and Preliminary Efficacy of ALLO-329, a Dual Anti-CD19/Anti-CD70 Allogeneic CAR T Cell Product in Autoimmune Disease
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 66 (estimated)
- Sponsor
- Allogene Therapeutics · Industry
- Sex
- All
- Age
- 18 Years – 69 Years
- Healthy volunteers
- Not accepted
Summary
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).
Conditions
- Systemic Lupus Erythematosus (With and Without Nephritis)
- Idiopathic Inflammatory Myopathy
- Systemic Sclerosis
Interventions
| Type | Name | Description |
|---|---|---|
| GENETIC | ALLO-329 | An allogeneic CAR T cell therapy targeting CD19 and CD70 |
| DRUG | Cyclophosphamide | Chemotherapy for lymphodepletion |
Timeline
- Start date
- 2025-11-13
- Primary completion
- 2028-02-01
- Completion
- 2032-10-01
- First posted
- 2025-07-25
- Last updated
- 2026-04-07
Locations
13 sites across 2 countries: United States, Canada
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT07085104. Inclusion in this directory is not an endorsement.