Master Protocol for the Phase 1 Study of Cell Therapies in Multiple Myeloma

What's the purpose of this trial?

Master protocol for cell therapy, Phase 1 proof-of-concept studies in relapsed and refractory multiple myeloma and includes long-term safety follow-up.

ARM 1 is a, non-randomized, open label, multi-site Phase 1 study. CART-ddBCMA is a BCMA directed CAR with a non-scFv binding domain that has been deimmunized.

This trial is currently open and accepting patients.


What will happen during the trial?

Additional Trial Information

Phase 1

Enrollment: 12 patients (estimated)

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Published Results

Arcellx Announces Presentation of Positive Clinical Results from Ongoing Phase 1 Study of CART-ddBCMA at the 2021 ASCO Annual Meeting

June 04, 2021

As previously announced, as of the April 14, 2021 data cutoff:

  • 12 of 12 patients achieved responses per IMWG criteria (median follow-up of 197 days; (Min – Max) 29-449 days)
    • 5 patients achieved stringent complete responses (sCR)
    • 1 patient achieved a complete response (CR)
    • 3 patients achieved very good partial responses (VGPR)
    • 3 patients achieved partial responses (PR)
  • One patient achieved VGPR despite prior progression on BCMA-targeted therapy
  • Responses in 11 patients are ongoing, with evidence that responses deepen over time

All patients enrolled in the study have poor prognostic factors with 10 of 12 patients penta-refractory and all 12 patients having had at least three prior treatments.

Trial Locations

All Trial Locations

View all clinical trial locations sorted by state.

Illinois

University of Chicago Medicine Comprehensive Cancer Center

Chicago, IL

Open and Accepting

Massachusetts

Massachusetts General Hospital

Boston, MA

Open and Accepting

Beth Israel Deaconess Medical Center

Boston, MA

Open and Accepting

Trial Links

Read the latest news and updates on this trial.

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