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NCT07221032
FT836 CAR T-cell Therapy in Combination With Daratumumab in Patients With Relapsed and/or Refractory Multiple Myeloma
Conditions: Relapse Multiple Myeloma, Refractory Multiple Myeloma
Sex: All
Ages: 18 Years – 80 Years
Healthy volunteers: No
Phase: PHASE1
Enrollment: 12
Sponsor: Medical College of Wisconsin
Location: Froedtert & the Medical College of Wisconsin Milwaukee Wisconsin
Summary
This is a phase I, interventional, single-arm, open-label, dose-finding treatment study designed to evaluate the safety and preliminary efficacy of FT836 in combination with daratumumab in adult patients with relapsed and/or refractory myeloma who have failed prior therapies.
Eligibility Criteria
Inclusion Criteria:
1. Patients must ≥18 years and \< 80 years old.
2. Patients must have received \>=3 prior lines of therapies, including proteasome inhibitor, immunomodulator and a CD38 monoclonal antibody:
• International Myeloma Working Group (IMWG) criteria define refractory disease as disease progression on or within 60 days of receiving therapy.
3. Patients must have measurable disease, including at least one or more of the following criteria:
1. Serum M-protein ≥ 0.5 g/dl;
2. Urine M-protein ≥ 200 mg/24 hrs;
3. Involved serum light chain ≥100 mg/L with abnormal light chain ratio;
4. Karnofsky performance score ≥70.
5. Adequate hepatic function, defined as:
1. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), and alkaline phosphatase \
Source: ClinicalTrials.gov (NCT07221032). StuddyBuddy aggregates publicly available trial information.
