FT500 as Monotherapy and in Combination With Immune Checkpoint Inhibitors in Subjects With Advanced Solid Tumors

Part of paid clinical trials in San Diego, California.

Sponsor
Fate Therapeutics
Study ID
NCT03841110
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • FT500 — DRUG
    FT500 is an allogeneic, iPSC-derived Natural Killer (NK) cell cancer immunotherapy
  • Nivolumab — DRUG
    Immune Checkpoint Inhibitor
  • Pembrolizumab — DRUG
    Immune Checkpoint Inhibitor
  • Atezolizumab — DRUG
    Immune Checkpoint Inhibitor
  • Cyclophosphamide — DRUG
    Lympho-conditioning agent
  • Fludarabine — DRUG
    Lympho-conditioning agent
  • IL-2 — DRUG
    Biologic response modifier

Study Details

FT500 is an off-the-shelf, iPSC-derived NK cell product that can bridge innate and adaptive immunity, and has the potential to overcome multiple mechanisms of immune checkpoint inhibitor (ICI) resistance. The preclinical data provide compelling evidence supporting the clinical investigation of FT500 as monotherapy and in combination with ICI in participants with advanced solid tumors.

Key Dates

Start date
Feb 15, 2019
Status verified
Apr 2023
Primary completion
Nov 15, 2022
Completion
Nov 15, 2022

Study Design

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

Arms

  • Experimental: FT500 Monotherapy
    FT500 administered once weekly for 3 weeks as a monotherapy
  • Experimental: FT500 in Combination with Immune Checkpoint Inhibitor
    FT500 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.
  • Experimental: FT500 +IL-2 in Combination with Immune Checkpoint Inhibitor
    FT500 + IL-2 administered once weekly for 3 weeks in combination with one of the following immune checkpoint inhibitors: nivolumab, pembrolizumab or atezolizumab.

Primary Outcome Measure

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

Locations (4)

FacilityCityStateZIPSite coordinators
UCSD Moores Cancer CenterSan DiegoCalifornia92093-
University of Minnesota Masonic Cancer CenterMinneapolisMinnesota55455-
Hackensack University Medical Center/John Theurer Cancer CenterHackensackNew Jersey07601-
MD Anderson Cancer CenterHoustonTexas77030-

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By research site
UCSD Moores Cancer Center· San Diego, CAUniversity of Minnesota Masonic Cancer Center· Minneapolis, MNHackensack University Medical Center/John Theurer Cancer Center· Hackensack, NJMD Anderson Cancer Center· Houston, TX

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