deltatrials
Recruiting PHASE1 INTERVENTIONAL 1-arm NCT05869955

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

A Phase 1, Multicenter, Open-Label Study Of CC-97540 (BMS-986353), CD19-Targeted Nex-T Chimeric Antigen Receptor (CAR) T Cells, in Participants With Severe, Refractory Autoimmune Diseases: Systemic Lupus Erythematosus, Idiopathic Inflammatory Myopathy, Systemic Sclerosis, or Rheumatoid Arthritis (Breakfree-1)

Sponsor: Bristol-Myers Squibb Services Unlimited Company

Updated 29 times since 2023 Last updated: Jan 12, 2026 Started: Sep 13, 2023 Primary completion: Aug 29, 2028 Completion: Aug 29, 2028
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT05869955, this PHASE1 trial focuses on Idiopathic Inflammatory Myopathy and Rheumatoid Arthritis and remains actively recruiting participants. Sponsored by Bristol-Myers Squibb Services Unlimited Company, it has been updated 29 times since 2023, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~Jun 2023 – ~Jul 2023 · 30 days · monthly snapshot~Jul 2023 – ~Aug 2023 · 31 days · monthly snapshot~Aug 2023 – ~Oct 2023 · 2 months · monthly snapshot~Oct 2023 – ~Nov 2023 · 31 days · monthly snapshot~Nov 2023 – ~Dec 2023 · 30 days · monthly snapshot~Dec 2023 – ~Jan 2024 · 31 days · monthly snapshot~Jan 2024 – ~Feb 2024 · 31 days · monthly snapshot~Feb 2024 – ~Mar 2024 · 29 days · monthly snapshot~Mar 2024 – ~Apr 2024 · 31 days · monthly snapshot~Apr 2024 – ~May 2024 · 30 days · monthly snapshot~May 2024 – ~Jun 2024 · 31 days · monthly snapshot~Jun 2024 – ~Jul 2024 · 30 days · monthly snapshot~Jul 2024 – ~Aug 2024 · 31 days · monthly snapshot~Aug 2024 – ~Sep 2024 · 31 days · monthly snapshot~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshot~Nov 2024 – ~Dec 2024 · 30 days · monthly snapshot~Dec 2024 – ~Jan 2025 · 31 days · monthly snapshot~Jan 2025 – ~Feb 2025 · 31 days · monthly snapshot~Feb 2025 – ~Mar 2025 · 28 days · monthly snapshot~Mar 2025 – ~Apr 2025 · 31 days · monthly snapshot~Apr 2025 – ~May 2025 · 30 days · monthly snapshot~May 2025 – ~Jun 2025 · 31 days · monthly snapshot~Jun 2025 – ~Jul 2025 · 30 days · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – ~Nov 2025 · 2 months · monthly snapshot~Nov 2025 – ~Dec 2025 · 30 days · monthly snapshot~Dec 2025 – ~Jan 2026 · 31 days · monthly snapshot~Jan 2026 – ~Feb 2026 · 31 days · monthly snapshot~Feb 2026 – present · 7 months · monthly snapshot

Change History

29 versions recorded
  1. Feb 2026 — Present [monthly]

    Recruiting PHASE1

  2. Jan 2026 — Feb 2026 [monthly]

    Recruiting PHASE1

  3. Dec 2025 — Jan 2026 [monthly]

    Recruiting PHASE1

  4. Nov 2025 — Dec 2025 [monthly]

    Recruiting PHASE1

  5. Sep 2025 — Nov 2025 [monthly]

    Recruiting PHASE1

Show 24 earlier versions
  1. Jul 2025 — Sep 2025 [monthly]

    Recruiting PHASE1

  2. Jun 2025 — Jul 2025 [monthly]

    Recruiting PHASE1

  3. May 2025 — Jun 2025 [monthly]

    Recruiting PHASE1

  4. Apr 2025 — May 2025 [monthly]

    Recruiting PHASE1

  5. Mar 2025 — Apr 2025 [monthly]

    Recruiting PHASE1

  6. Feb 2025 — Mar 2025 [monthly]

    Recruiting PHASE1

  7. Jan 2025 — Feb 2025 [monthly]

    Recruiting PHASE1

  8. Dec 2024 — Jan 2025 [monthly]

    Recruiting PHASE1

  9. Nov 2024 — Dec 2024 [monthly]

    Recruiting PHASE1

  10. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE1

  11. Aug 2024 — Sep 2024 [monthly]

    Recruiting PHASE1

  12. Jul 2024 — Aug 2024 [monthly]

    Recruiting PHASE1

  13. Jun 2024 — Jul 2024 [monthly]

    Recruiting PHASE1

  14. May 2024 — Jun 2024 [monthly]

    Recruiting PHASE1

  15. Apr 2024 — May 2024 [monthly]

    Recruiting PHASE1

  16. Mar 2024 — Apr 2024 [monthly]

    Recruiting PHASE1

  17. Feb 2024 — Mar 2024 [monthly]

    Recruiting PHASE1

  18. Jan 2024 — Feb 2024 [monthly]

    Recruiting PHASE1

  19. Dec 2023 — Jan 2024 [monthly]

    Recruiting PHASE1

  20. Nov 2023 — Dec 2023 [monthly]

    Recruiting PHASE1

  21. Oct 2023 — Nov 2023 [monthly]

    Recruiting PHASE1

  22. Aug 2023 — Oct 2023 [monthly]

    Recruiting PHASE1

    Status: Not Yet RecruitingRecruiting

  23. Jul 2023 — Aug 2023 [monthly]

    Not Yet Recruiting PHASE1

  24. Jun 2023 — Jul 2023 [monthly]

    Not Yet Recruiting PHASE1

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Bristol-Myers Squibb Services Unlimited Company
  • Juno Therapeutics, Inc., a Bristol-Myers Squibb Company
Data source: Juno Therapeutics, Inc., a Bristol-Myers Squibb Company

For direct contact, visit the study record on ClinicalTrials.gov .