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

  • STATUS
    Recruiting
  • End date
    Nov 1, 2035
  • participants needed
    65
  • sponsor
    Arcellx, Inc.
Updated on 25 March 2022

Summary

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

Description

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.

ARM 2 is a non-randomized, open label, multi-site Phase 1 study. Using the bivalent BCMA-Specific Adapter (SPRX001) and Universal CAR-Modified T cell (ARC-T Cells)

Details
Condition Relapsed and Refractory Multiple Myeloma
Treatment CART-ddBCMA, ARC-T Plus Anti-BCMA SparX
Clinical Study IdentifierNCT04155749
SponsorArcellx, Inc.
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Relapsed and refractory Multiple Myeloma treated with at least 3 prior regimens of system therapy including Proteosome Inhibitor (PI), immunomodulatory drugs (IMiD), and anti-CD38 antibody (CD38mab); or has "triple-refractory" disease
Documented measurable disease
Adequate organ function
Life expectancy > 12 weeks, Eastern Cooperative Group Performance Status 0-1

Exclusion Criteria

Plasma Cell Leukemia or History of Plasma Cell Leukemia
Patients with a history of severe hypersensitivity to DMSO should be excluded
Contraindication to fludarabine or cyclophosphamide
Severe uncontrolled intercurrent illness (e.g., infection) or laboratory abnormalities
Active central nervous system disease involvement by malignancy or active CNS pathology
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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