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

  • Interventional
  • Recruiting
  • NCT04155749
Eligibility Details Visit Clinicaltrials.gov

Master Protocol for the Phase 1 Study of Cell Therapies for the Treatment of Patients With Relapsed Refractory Multiple Myeloma, Including Long-term Safety Follow-up

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.

Gender
All

Age Group
18 Years and up

Accepting Healthy Volunteers?
No

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

At a Glance

National Government IDNCT04155749

IRB#IRB19-0638

Lead SponsorArcellx, Inc.

Lead PhysicianMichael R. Bishop

Collaborator(s)N/A

EligibilityAll
18 Years and up
Recruiting