FT538 in Subjects With Advanced Hematologic Malignancies

Part of paid clinical trials in Denver, Colorado.

Sponsor
Fate Therapeutics
Study ID
NCT04614636
Phase
PHASE1
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • FT538 — DRUG
    Experimental Interventional Therapy, Allogeneic Cell Therapy NK Cell
  • Cyclophosphamide — DRUG
    Lympho-conditioning Agent
  • Fludarabine — DRUG
    Lympho-conditioning Agent
  • Daratumumab — DRUG
    Monoclonal Antibody, CD38, Anti-CD38
  • Elotuzumab — DRUG
    Monoclonal Antibody

Study Details

This is a Phase I dose-finding study of FT538 as monotherapy in acute myeloid leukemia (AML) and in combination with monoclonal antibodies in multiple myeloma (MM). The study will consist of a dose-escalation stage and an expansion stage where participants will be enrolled into indication-specific cohorts.

Key Dates

Start date
Oct 17, 2020
Status verified
Sep 2023
Primary completion
Jul 13, 2023
Completion
Aug 8, 2023

Study Design

Enrollment
42 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: FT538 Monotherapy
    FT538 monotherapy in subjects with r/r AML
  • Experimental: FT538 in Combination with Daratumumab
    FT538 in combination with daratumumab in subjects with r/r MM
  • Experimental: FT538 in Combination with Elotuzumab
    FT538 in combination with elotuzumab in subjects with r/r MM

Primary Outcome Measure

Incidence of dose-limiting toxicities (DLTs) within each dose level cohort [ Time Frame: Cycle 1, Up to Day 29 ]

Locations (8)

FacilityCityStateZIPSite coordinators
Colorado Blood Cancer InstituteDenverColorado80218-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-
Washington UniversitySt LouisMissouri63110-
Memorial Sloan Kettering Cancer CenterNew YorkNew York10065-
Sarah Cannon Research Institute at Tennessee OncologyNashvilleTennessee37203-
St. David's South Austin Medical CenterAustinTexas78704-
MD Anderson Cancer CenterHoustonTexas77030-
Texas Transplant InstituteSan AntonioTexas78229-

Find similar trials in Denver, CO

By condition
Leukemia (other)Multiple myeloma
By specialty
OncologyBlood cancer
By research site
Colorado Blood Cancer Institute· Denver, COUniversity of Minnesota Masonic Cancer Center· Minneapolis, MNWashington University· St Louis, MOMemorial Sloan Kettering Cancer Center· New York, NYSarah Cannon Research Institute at Tennessee Oncology· Nashville, TNSt. David's South Austin Medical Center· Austin, TX

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