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A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
NCT07085104 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 1, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 54 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Allogene Therapeutics, which has 5 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT07085104 reports 10 study locations spanning 9 distinct geographic areas — top geographies include South Carolina, Arizona, Iowa. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07085104?
The interventions under investigation include: ALLO-329 (GENETIC), Cyclophophamide (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07085104?
This trial is sponsored by Allogene Therapeutics, which has 5 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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