FT576 in Subjects With Multiple Myeloma

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Fate Therapeutics
Study ID
NCT05182073
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • FT576 (Allogenic CAR NK cells with BCMA expression) — DRUG
    Experimental Interventional Therapy: FT576 comprises allogeneic natural killer (NK) cells, derived from a clonal, CD38-knockout, human-induced pluripotent stem cell line (iPSC) that expresses anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR), high-affinity, non-cleavable CD16 (hnCD16), and IL-15/IL-15 receptor fusion protein (IL-15RF).
  • Cyclophosphamide — DRUG
    Conditioning Agent
  • Fludarabine — DRUG
    Conditioning Agent
  • Daratumumab — DRUG
    Anti-CD38 Monoclonal Antibody
  • Bendamustine — DRUG
    Conditioning Agent

Study Details

This 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 Dates

Start date
Nov 10, 2021
Status verified
Sep 2025
Primary completion
Sep 20, 2024
Completion
Oct 18, 2024

Study Design

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

Arms

  • Experimental: Regimens A-A4
    FT576 single dose monotherapy in subjects with r/r MM
  • Experimental: Regimen A1
    FT576 multiple dose monotherapy in subjects with r/r MM
  • Experimental: Regimens B-B4
    FT576 single dose in combination with daratumumab in subjects with r/r MM
  • Experimental: Regimen B1
    FT576 multiple dose in combination with daratumumab in subjects with r/r MM

Primary Outcome Measure

Incidence and nature of DLTs within each dose-escalation cohort to determine the MTD or MAD [ Time Frame: Cycle 1 Day -5 to Day 29 for Regimen A and A1; Cycle 1 Day -11 to Day 29 (each cycle is 40 days) for Regimen B and B1 ]

Locations (14)

FacilityCityStateZIPSite coordinators
University of Alabama at BirminghamBirminghamAlabama35205-
City of HopeDuarteCalifornia91010-
Scri-CbciDenverColorado80218-
Medical Oncology Hematology ConsultantsNewarkDelaware19713-
Indiana UniversityIndianapolisIndiana46202-
University of MinnesotaSaint PaulMinnesota55108-
Washington UniversitySt LouisMissouri63130-
Roswell ParkBuffaloNew York14263-
Levine Cancer InstituteCharlotteNorth Carolina28204-
Oncology Hematology Care, IncCincinnatiOhio45226-
Tennessee Oncology - NashvilleNashvilleTennessee37203-
Texas Oncology-Medical City DallasDallasTexas75230-
Virginia Oncology AssociatesNorfolkVirginia23502-
Medical College of WisconsinMilwaukeeWisconsin53226-

Find similar trials in Birmingham, AL

By condition
Multiple myeloma
By specialty
OncologyBlood cancer
By research site
University of Alabama at Birmingham· Birmingham, ALCity of Hope· Duarte, CAScri-Cbci· Denver, COMedical Oncology Hematology Consultants· Newark, DEIndiana University· Indianapolis, INUniversity of Minnesota· Saint Paul, MN

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