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

Not Applicable

Recruiting

• Conditions: Refractory Autoimmune Diseases
• Interventions: Genetic: BMS-986515; Drug: Fludarabine; Drug: Cyclophosphamide; Drug: Tocilizumab

• Registration Number: NCT07115745
• Lead Sponsor: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-02-07
• Study First Submitted QC: 2025-08-04
• Study First Posted: 2025-08-11
• Study Start: 2025-09-04
• Status Verified: 2025-10
• Last Update Submitted: 2025-10-06
• Last Update Posted: 2025-10-07
• Primary Completion: 2029-02-13
• Study Completion: 2030-08-16

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 125

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BMS-986515 Administration	BMS-986515	-
BMS-986515 Administration	Fludarabine	-
BMS-986515 Administration	Cyclophosphamide	-
BMS-986515 Administration	Tocilizumab	-

Primary Outcome Measures

Name	Time	Method
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 abnormalities	Up 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 period	28 days post-BMS-986515 infusion	All participants

Secondary Outcome Measures

Name	Time	Method
Maximum observed concentration (Cmax)	Up to 2 years	All participants
Area under the concentration-time curve (AUC)	Up to 2 years	All participants
Time of maximum observed concentration (Tmax)	Up to 2 years	All participants
Number of participants with interstitial lung disease (ILD) with no worsening of pulmonary function from baseline to Week 24	Up to 2 years	All participants
Number of participants who achieve definition of remission in systemic lupus erythematosus (DORIS) remission at Week 24	Up to Week 24	Systemic lupus erythematosus (SLE) participants
Number of participants who achieve Lupus Low Disease Activity State (LLDAS) at Week 24	Up to Week 24	SLE participants
Change in proteinuria measured by urine protein creatinine ratio (UPCR) from baseline to Week 24	Up to Week 24	SLE participants
Change in Health Assessment Questionnaire-Disability Index (HAQ-DI) from baseline to Week 24	Up to Week 24	SLE, systemic sclerosis (SSc), and rheumatoid arthritis (RA) participants
Number of participants who achieve Myositis Response Criteria Total Improvement Score (MRC TIS) at Week 24	Up to Week 24	Inflammatory myopathy (IIM) participants
Change in International Myositis Outcome Assessment Collaborative Study Group (IMACS) outcome measure set for disease activity at week 24 from baseline	Up to Week 24	IIM participants
Change in Cutaneous Dermatomyositis Disease Area and Severity Index (CDASI) at week 24 from baseline	Up to Week 24	Dermatomyositis (DM) participants only
Number of participants who achieve an minimal clinically important differences in SSc (MCID) from baseline of the modified Rodnan Skin Score (mRSS) at Week 24	Up to Week 24	SSc participants
Change from baseline of the Revised Composite Response Index in Systemic Sclerosis (CRISS) at Week 24	Up to Week 24	SSc participants
Number of participants with low disease activity at Week 24 from baseline	Up to Week 24	RA participants

Trial Locations

Locations (29)

Fundeni Clinical Institute; 🇷🇴 Bucharest, Romania

Local Institution - 0041; 🇺🇸 Boston, Massachusetts, United States

Local Institution - 0037; 🇺🇸 Durham, North Carolina, United States

Local Institution - 0033; 🇺🇸 Seattle, Washington, United States

Local Institution - 0007; 🇦🇺 Camperdown, New South Wales, Australia

Local Institution - 0008; 🇦🇺 Brisbane, Queensland, Australia

Local Institution - 0013; 🇦🇺 Clayton, Victoria, Australia

Local Institution - 0040; 🇧🇷 Salvador, Estado de Bahia, Brazil

Local Institution - 0039; 🇧🇷 Porto Alegre, Brazil

Local Institution - 0038; 🇧🇷 São Paulo, Brazil

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