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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: Recruiting Phase 1 study of Systemic Sclerosis and Idiopathic Inflammatory Myopathy, sponsored by Allogene Therapeutics.
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. According to ClinicalTrials.gov, the official US trial registry.
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).
Primary Outcome
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)
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 |
What NCT07085104 shows while recruiting
NCT07085104 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 54 participants, a relatively small participant target, below the 277-participant average among 26 other Systemic Sclerosis trials with a reported enrollment target (81% lower).
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 lists 10 locations in 9 states (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.
Learn More About Clinical Trials
Similar trials for Systemic Sclerosis
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT07085104's enrollment target sits among peer trials
54 13th of 26 higher than 14 of 26 other Systemic Sclerosis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Systemic Sclerosis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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