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Trial Summary


Protocol No.CTO-FT576-101
StatusOPEN TO ACCRUAL
Principal InvestigatorAbonour, Rafat
ScopeNational
PhasePhase I
Age GroupAdult
TitleA Phase I Study of FT576 as Monotherapy and in Combination with Daratumumab in Subjects with Relapsed/Refractory Multiple Myeloma
DescriptionThis is a Phase I dose-finding study of FT576 as monotherapy and in combination with the monoclonal antibody daratumumab in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage.
Key Eligibility

In order to be eligible to take part in this trial, patients must meet the following criteria:

Diagnosis of r/r MM with measurable disease by at least one of the following:

  • Serum M-protein ≥1.0 g/dL
  • Urine M-protein ≥200 mg/24 hours
  • Involved serum free light chain level ≥10 mg/dL, with an abnormal kappa-lambda ratio if the serum M-protein <1.0 g/dL and/or urine M-protein <200 mg/24 hours
  • Regimens A and A1: MM relapsed or progressed after ≥3 prior approved therapies, including an IMiD, proteosome inhibitor, and anti-CD38 mAb
  • Regimens B and B1: MM relapsed or progressed after ≥2 prior approved therapies, including an IMiD and PI

For a full list of participation criteria, please visit clinicaltrials.gov.

Applicable Disease SitesMultiple Myeloma
Participating InstitutionsIndiana University (IU)
    Treatment TypeTreatment
    ContactPhone: (317) 278-5632
    Email: iutrials@iu.edu