MT-401 for Acute Myeloid Leukemia Post-Stem Cell Transplant (ARTEMIS Trial)

Recruiting in Palo Alto (17 mi)

+18 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Marker Therapeutics, Inc.

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?This study is a Phase 2 multicenter study with a Safety Lead-in evaluating safety and efficacy of MT-401 administration to patients with AML, who have received their first allogeneic HSCT. The dose administered is 50 x 10\^6 cells (flat dosing).

Eligibility Criteria

This trial is for adults over 18 with Acute Myeloid Leukemia (AML) who've had their first stem cell transplant and are in remission without detectable disease. They must have good performance status, adequate organ function, and a life expectancy of at least 12 weeks. Those with severe graft-versus-host disease or significant infections can't participate.

Inclusion Criteria

My cancer has returned after my stem cell transplant.

My AML has returned after my first bone marrow transplant.

I am about to have my first stem cell transplant and my cancer is not detectable before the transplant.

I am 18 years old or older.

I can care for myself but may need occasional help.

My liver tests are within the required range.

My kidney function is within the required range.

Exclusion Criteria

I am receiving other cancer treatments alongside or after MT-401.

I am currently suffering from a severe infection.

Participant Groups

The study tests MT-401's safety and effectiveness in AML patients post-first allogeneic stem cell transplant. It's a Phase 2 trial where participants receive a set dose of MT-401 to see if it helps prevent leukemia from returning.

3Treatment groups

Experimental Treatment

Active Control

Group I: MT-401 following relapseExperimental Treatment1 Intervention

Treatment with MT-401 following relapse after first HSCT

Group II: MT-401 following HSCTExperimental Treatment1 Intervention

Treatment with MT-401 at 90 days following HSCT

Group III: Standard of Care following HSCTActive Control1 Intervention

Standard of Care