FT516 in Subjects With Advanced Hematologic Malignancies

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
Fate Therapeutics
Study ID
NCT04023071
Phase
PHASE1
Status
Terminated

Conditions

  • Acute Myelogenous Leukemia
  • B-cell Lymphoma

Eligibility Criteria

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

Interventions

  • FT516 — DRUG
    Experimental Interventional Therapy
  • Rituximab — DRUG
    Monoclonal Antibody
  • Obinutuzumab — DRUG
    Monoclonal Antibody
  • Cyclophosphamide — DRUG
    Conditioning agent
  • Fludarabine — DRUG
    Conditioning agent
  • IL-2 — DRUG
    Biologic response modifier
  • Bendamustine — DRUG
    Conditioning agent

Study Details

This is a Phase 1/1b dose-finding study of FT516 as monotherapy in acute myeloid leukemia (AML) and in combination with CD20 directed monoclonal antibodies in B-cell lymphoma. The study includes three stages: dose escalation, safety confirmation, and dose expansion.

Key Dates

Start date
Oct 4, 2019
Status verified
Oct 2023
Primary completion
Oct 23, 2023
Completion
Oct 23, 2023

Study Design

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

Arms

  • Experimental: FT516 Monotherapy
    FT516 monotherapy in adult subjects with r/r AML.
  • Experimental: FT516 in Combination with Monoclonal Antibodies
    FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
  • Experimental: FT516 in Combination with Monoclonal Antibodies on an Extended-Dosing Schedule
    FT516 on an extended-dosing schedule in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.
  • Experimental: FT516 in Combination with Monoclonal Antibodies following Bendamustine Conditioning
    Bendamustine conditioning followed by FT516 in combination with one of the following monoclonal antibodies in adult subjects with r/r B-cell lymphoma: rituximab or obinutuzumab.

Primary Outcome Measure

The incidence of subjects with Dose Limiting Toxicities within each dose level cohort. [ Time Frame: Day 29 ]

Locations (7)

FacilityCityStateZIPSite coordinators
Mayo ClinicPhoenixArizona85054-
UC San DiegoSan DiegoCalifornia92037-
University of Colorado, DenverDenverColorado80045-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-
UT SouthwesternDallasTexas75390-
MD Anderson Cancer CenterHoustonTexas77030-
Swedish Cancer InstituteSeattleWashington98104-

Find similar trials in Phoenix, AZ

By research site
Mayo Clinic· Phoenix, AZUC San Diego· San Diego, CAUniversity of Colorado, Denver· Denver, COUniversity of Minnesota Masonic Cancer Center· Minneapolis, MNUT Southwestern· Dallas, TXMD Anderson Cancer Center· Houston, TX

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