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A Study of CC-97540, CD-19-Targeted Nex-T CAR T Cells, in Participants With Severe, Refractory Autoimmune Diseases (Breakfree-1)

NCT05869955 · Status: RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 270

Last updated 2026-05-04

No results posted yet for this study

Summary

The purpose of this study is to establish the tolerability, preliminary efficacy, and pharmacokinetics of CC-97540 in participants with severe, refractory autoimmune diseases (Breakfree-1).

Conditions

Interventions

DRUG

CC-97540

Specified dose on specified days

DRUG

Fludarabine

Specified dose on specified days

DRUG

Cyclophosphamide

Specified dose on specified days

DRUG

Tocilizumab

Specified dose on specified days

Sponsors & Collaborators

  • Bristol-Myers Squibb Services Unlimited Company

    collaborator UNKNOWN

  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

    lead INDUSTRY

Principal Investigators

  • Bristol-Myers Squibb · Bristol-Myers Squibb

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-09-13
Primary Completion
2028-08-29
Completion
2028-08-29
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • France
  • Germany
  • Italy
  • Spain

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05869955 on ClinicalTrials.gov