FT538 + Daratumumab for Acute Myeloid Leukemia

Recruiting in Palo Alto (17 mi)

Overseen by Joseph Maakaron, MD

Age: Any Age

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Masonic Cancer Center, University of Minnesota

No Placebo Group

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?

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.

Research Team

Joseph Maakaron, MD

Principal Investigator

Masonic Cancer Center, University of Minnesota

Eligibility Criteria

This trial is for people aged 12 and older with advanced acute myeloid leukemia (AML) or related diseases, weighing at least 50 kg. Participants must have a heart function of LVEF ≥ 40%, adequate organ function, and agree to use effective contraception. It excludes those with certain other medical conditions, recent treatments, active infections, cardiovascular disease requiring immunosuppression, or known allergies to study drugs.

Inclusion Criteria

I am 12 years old or older.

I weigh at least 50 kg.

I am using effective birth control and will continue for 12 months after my last treatment.

Exclusion Criteria

I have been diagnosed with acute promyelocytic leukemia.

Known seropositive for HIV or known active Hepatitis B or C infection with detectable viral load by PCR

My cancer returned less than 3 months after my stem cell transplant.

Treatment Details

Interventions

• Daratumumab/rHuPH20 (Monoclonal Antibodies)
• FT538 (CAR T-cell Therapy)

Trial Overview The trial tests the combination of FT538 cells with Daratumumab in patients with AML. The goal is to find the highest dose that's safe (MTD). Patients will receive escalating doses of FT538 alongside standard doses of Daratumumab as well as Fludarabine and Cyclophosphamide pre-treatment.

Participant Groups

Group I: Dose Level 4: FT538 at 1.5 x10^9 cells/dose Experimental Treatment 4 Interventions

FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15

Group II: Dose Level 3: FT538 at 1 x10^9 cells/dose Experimental Treatment 4 Interventions

FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15

Group III: Dose Level 2: FT538 at 3 x10^8 cells/dose Experimental Treatment 4 Interventions

FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15

Group IV: Dose Level 1: FT538 at 1 x10^8 cells/dose Experimental Treatment 4 Interventions

FT538 administered at assigned dose as an IV infusion via gravity on Day 1, Day 8, and Day 15

Daratumumab/rHuPH20 is already approved in Canada, Japan for the following indications:

Approved in Canada as Darzalex for:

• Multiple myeloma

Approved in Japan as Darzalex for:

• Multiple myeloma

Who Is Running the Clinical Trial?

Masonic Cancer Center, University of Minnesota

Lead Sponsor

Trials

285

Recruited

15,700+

Dr. Melissa A. Geller

Masonic Cancer Center, University of Minnesota

Chief Medical Officer since 2022

MD from University of Minnesota

Dr. Jeffrey Miller

Masonic Cancer Center, University of Minnesota

Chief Executive Officer

MD from University of Minnesota