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NCT07115745 · ClinicalTrials.gov registry record · Phase 1

A Study of Healthy Donor CD19-targeted Allogeneic CAR T Cells in Participants With Severe, Refractory Autoimmune Diseases

A Phase 1 study of Refractory Autoimmune Diseases, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

Recruiting
Registry status
Phase 1
Development phase
125
Enrollment target
20
Study locations

NCT07115745: Recruiting Phase 1 study of Refractory Autoimmune Diseases, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

NCT07115745 is a Phase 1 study of Refractory Autoimmune Diseases that is actively recruiting participants, run by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company. The registered enrollment target is 125 participants, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher). The trial reports 20 study locations across 14 states. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT07115745, a Phase 1 study of Refractory Autoimmune Diseases, is actively recruiting participants, sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company.

RECRUITING
Registry status
Phase 1
Development phase
125 participants
Enrollment target
20
Study locations

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.

Primary Outcome

All participants

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

FieldValue
Enrollment Target 125 participants
Start Date 2025-09-04
Est. Completion 2030-08-16
Phase Phase 1

What NCT07115745 shows while recruiting

NCT07115745 is an interventional study that assigns participants to a tested intervention. The registered 125 participants enrollment target is mid-sized for trials with a published cap, above the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (108% higher).

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.

NCT07115745 names 20 study sites across 14 states, led by Other, Massachusetts, North Carolina.

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.

What interventions are being tested in trial NCT07115745?

The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), Tocilizumab (DRUG), BMS-986515 (GENETIC).

Who is sponsoring clinical trial NCT07115745?

This trial is sponsored by Juno Therapeutics, Inc., a Bristol-Myers Squibb Company, which has 14 total clinical trials registered on ClinicalTrials.gov.

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.

How this trial's enrollment target compares

Where NCT07115745's enrollment target sits among peer trials

125 467th of 2000 higher than 1,530 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 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.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT07115745, the US trial registry maintained by the National Library of Medicine. NCT07115745 (mid enrollment · wide site footprint · recruiting) retrieved and formatted by PlainTrial, see methodology.