FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia

PHASE1CompletedINTERVENTIONAL
Enrollment

9

Participants

Timeline

Start Date

November 3, 2021

Primary Completion Date

January 9, 2024

Study Completion Date

October 15, 2024

Conditions
Acute Myeloid LeukemiaMyeloid LeukemiaMonocytic Leukemia
Interventions
DRUG

Daratumumab/rHuPH20

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.

DRUG

FT538

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

DRUG

Fludarabine

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).

DRUG

Cyclophosphamide

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.

Trial Locations (1)

55455

Masonic Cancer Center, University of Minnesota, Minneapolis

All Listed Sponsors
lead

Masonic Cancer Center, University of Minnesota

OTHER

NCT04714372 - FT538 in Combination With Daratumumab in AML Acute Myeloid Leukemia | Biotech Hunter | Biotech Hunter