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NCT07085104 · ClinicalTrials.gov registry record · Phase 1
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 of Systemic Sclerosis and Idiopathic Inflammatory Myopathy, sponsored by Allogene Therapeutics.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 54
- Enrollment target
- 10
- Study locations
NCT07085104 is a Phase 1 study of Systemic Sclerosis and Idiopathic Inflammatory Myopathy that is actively recruiting participants, run by Allogene Therapeutics. The registered enrollment target is 54 participants, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (81% lower). The trial reports 10 study locations across 9 states.
The verdict
NCT07085104, a Phase 1 study of Systemic Sclerosis and Idiopathic Inflammatory Myopathy, is actively recruiting participants, sponsored by Allogene Therapeutics.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 54 participants
- Enrollment target
- 10
- Study locations
Study 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 Studied
Interventions
- GENETIC ALLO-329
- DRUG Cyclophophamide
Study Locations (10)
South Carolina
- Medical University of South Carolina - Charleston
- Prisma Health - Greenville
Arizona
- Mayo Clinic - Phoenix
Iowa
- University of Iowa - Iowa City
Kentucky
- Norton Cancer Institute, St. Matthews Campus - Louisville
New Jersey
- Astera Cancer Care - East Brunswick
New York
- Icahn School of Medicine at Mount Sinai - New York
North Carolina
- Duke University Medical Center - Durham
Utah
- LDS Hospital - lntermountain Health - Salt Lake City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 54 participants |
| Start Date | 2025-11-13 |
| Est. Completion | 2032-10 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07085104
The ClinicalTrials.gov registry entry for NCT07085104 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (81% lower). The listed sponsor is Allogene Therapeutics, which has 8 total studies on file at ClinicalTrials.gov.
The record links to 3 conditions, with Systemic Sclerosis appearing as the primary indexed condition, and to 2 interventions - of which ALLO-329 is the first listed.
NCT07085104 reports 10 study locations spanning 9 distinct geographic areas - top geographies include South Carolina, Arizona, Iowa.
Frequently Asked Questions
What is clinical trial NCT07085104 about?
NCT07085104 is a clinical study titled "A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease". 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 (...
What is the current status of trial NCT07085104?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 54 participants. The study started on 2025-11-13. Estimated completion is 2032-10.
What conditions does trial NCT07085104 study?
This clinical trial studies the following conditions: Systemic Sclerosis, Idiopathic Inflammatory Myopathy, Systemic Lupus Erythematosus (With and Without Nephritis).
What interventions are being tested in trial NCT07085104?
The interventions under investigation include: ALLO-329 (GENETIC), Cyclophophamide (DRUG).
Who is sponsoring clinical trial NCT07085104?
This trial is sponsored by Allogene Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT07085104 being conducted?
This trial has 10 study locations across Arizona, Iowa, Kentucky, New Jersey, New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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