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A Study of BMS-986515 for Severe, Refractory Autoimmune Diseases

This study is testing a new treatment called BMS-986515, which uses healthy donor CAR T-cells (a type of immune cell engineered to fight disease), for people with severe autoimmune diseases that haven't responded to other treatments. You might also receive other medications like Fludarabine, Cyclophosphamide, and Tocilizumab. The main goal is to see how safe BMS-986515 is and if it causes any side effects. Researchers will also look at how well it works. To join, you must be at least 18 years old and have a diagnosis of Systemic Lupus Erythematosus (SLE) with specific antibodies detected in your blood. This study is currently recruiting about 125 participants.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It plans to enroll 125 participants.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for side effects for up to 24 months after receiving BMS-986515.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT07115745

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

Recruiting
PHASE1Ages 18+InterventionalTreatment
Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
~125 participants
Updated 2026-07-14 on ClinicalTrials.gov
What's tested:BMS-986515FludarabineCyclophosphamideTocilizumab

At a glance

Recruiting sites
19 of 28 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Number of participants with treatment-emergent adverse events (TEAEs)
Measured over Up to 24 months post BMS-986515 infusion
+5 more outcomes measured

Conditions

Refractory Autoimmune Diseases

Explore related trials

Idiopathic Inflammatory MyopathyRheumatoid ArthritisSystemic Lupus ErythematosusSystemic Scleroderma

Where it's being run

28 sites across 24 states
Germany3
Brazil2
Silesian Voivodeship2
Massachusetts1
North Carolina1
New South Wales1
Queensland1
Victoria1

Study leadership

  • Bristol-Myers Squibb · STUDY_DIRECTOR · Bristol-Myers Squibb

Who to contact

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
[email protected]
855-907-3286
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Exclusion

SLE population:.
IIM population:.
SSc population:.
RA population:.

What this trial measures

  • Number of participants with treatment-emergent adverse events (TEAEs)Up to 24 months post BMS-986515 infusion

    All participants

  • Number of participants with serious AEs (SAEs)Up to 24 months post BMS-986515 infusion

    All participants

  • Number of participants with AEs of special interest (AESIs)Up to 24 months post BMS-986515 infusion

    All participants

  • Number of participants with laboratory abnormalitiesUp to 24 months post BMS-986515 infusion

    All participants

  • Number of participants with Dose-Limiting Toxicities (DLTs)Up to 24 months post BMS-986515 infusion

    All participants

  • Number of participants with DLTs that occur during the DLT evaluation period28 days post-BMS-986515 infusion

    All participants