FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia

Part of paid clinical trials in Minneapolis, Minnesota.

Sponsor
Masonic Cancer Center, University of Minnesota
Study ID
NCT04714372
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • Daratumumab/rHuPH20 — DRUG
    Daratumumab 1800 mg co-formulated with 30,000 units of hyaluronidase (rHuPH20) given subcutaneously into subcutaneous tissue of the abdomen approximately 3 inches \[7.5 cm\] to the right or left of the navel over approximately 3-5 minutes on Day -12 and Day -5 prior to the 1st FT538 infusion, and on Day +3, Day+10, and Day+17 approximately 48 hours after each FT538 infusion.
  • FT538 — DRUG
    FT538 is administered as an IV infusion via gravity using an IV administration set with an in-line filter at the patient's assigned dose levels (DL) on Day 1, Day 8, and Day 15
  • Fludarabine — DRUG
    Fludarabine 25 mg/m\^2 is administered as a 1 hour intravenous (IV) infusion per institutional guidelines once a day on 2 consecutive days (Day -4, and Day -3).
  • Cyclophosphamide — DRUG
    Cyclophosphamide 300 mg/m\^2 is administered as a 2 hour intravenous (IV) infusion per institutional guidelines once a day on the same days that fludarabine is given.

Study Details

This Phase I open-label dose escalation study is conducted in two stages with a primary endpoint to identify the maximum tolerated dose (MTD) of FT538 when administered with daratumumab in patients 12 years and older with advanced acute myeloid leukemia (AML) and related myeloid diseases.

Key Dates

Start date
Nov 3, 2021
Status verified
Oct 2024
Primary completion
Jan 9, 2024
Completion
Oct 15, 2024

Study Design

Enrollment
9 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Dose Level 1: FT538 at 1 x10^8 cells/dose
    FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
  • Experimental: Dose Level 2: FT538 at 3 x10^8 cells/dose
    FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
  • Experimental: Dose Level 3: FT538 at 1 x10^9 cells/dose
    FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15
  • Experimental: Dose Level 4: FT538 at 1.5 x10^9 cells/dose
    FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15

Primary Outcome Measure

Number of Participants Experiencing Dose Limiting Toxicity (DLT) Events [ Time Frame: 42 days from the 1st FT538 infusion ]

Locations (1)

FacilityCityStateZIPSite coordinators
Masonic Cancer Center, University of MinnesotaMinneapolisMinnesota55455-

Find similar trials in Minneapolis, MN

By condition
Leukemia (other)
By specialty
OncologyBlood cancer
By research site
Masonic Cancer Center, University of Minnesota· Minneapolis, MN

Related Studies