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A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases
NCT07115745 · View on ClinicalTrials.gov ↗
Study Summary
The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG Tocilizumab
- GENETIC BMS-986515
Study Locations (20)
Other
- Local Institution - 0039 — Porto Alegre
- Local Institution - 0038 — São Paulo
- Revmatologicky ustav — Prague
- Charité - Universitaetsmedizin Berlin - Campus Bejnamin Franklin — Berlin
- Universitätsklinikum Carl Gustav Carus an der TU Dresden — Dresden
- Local Institution - 0031 — Hamburg
- Hadassah Medical Center — Jerusalem
Massachusetts
- Local Institution - 0041 — Boston
North Carolina
- Local Institution - 0037 — Durham
New South Wales
- Local Institution - 0007 — Camperdown
Queensland
- Local Institution - 0008 — Brisbane
Victoria
- Local Institution - 0013 — Clayton
Estado de Bahia
- Local Institution - 0040 — Salvador
Praha 5
- Local Institution - 0004 — Prague
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 125 participants |
| Start Date | 2025-09-04 |
| Est. Completion | 2030-08-16 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07115745
The ClinicalTrials.gov registry entry for NCT07115745 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 125 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 12 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Refractory Autoimmune Diseases appearing as the primary indexed condition, and to 4 interventions — of which Cyclophosphamide 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: NCT07115745 reports 20 study locations spanning 14 distinct geographic areas — top geographies include Other, Massachusetts, North Carolina. 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 NCT07115745 about?
NCT07115745 is a clinical study titled "A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases". The purpose of this study is to determine the safety, tolerability, optimal dose, and preliminary efficacy of BMS-986515, a healthy donor (HD) allogeneic CD19-targeted CART cell product, in participants with severe, refractory autoimmune diseases.
What is the current status of trial NCT07115745?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 125 participants. The study started on 2025-09-04. Estimated completion is 2030-08-16.
What conditions does trial NCT07115745 study?
This clinical trial studies the following conditions: Refractory Autoimmune Diseases. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT07115745?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tocilizumab (DRUG), BMS-986515 (GENETIC). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT07115745?
This trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 12 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT07115745 being conducted?
This trial has 20 study locations across Massachusetts, North Carolina, New South Wales, Queensland, Victoria. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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