Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

Active:	No
Cancer Type:	Leukemia	NCT ID:	NCT04511130
Trial Phases:	Phase II	Protocol IDs:	MRKR-19-401 (primary) NCI-2020-07647
Eligibility:	18 Years and older, Male and Female	Study Type:	Treatment
Study Sponsor:	Marker Therapeutics, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT04511130

Summary

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).

Objectives

This study is in patients aged =18 years old undergoing or having relapsed after their first
allogeneic HSCT (matched sibling, matched unrelated donor, or haploidentical transplants) for
AML.

Potential patients for the study may be screened/enrolled:

• Prior to their first allogeneic HSCT.

or

• Patients experiencing their first relapse post-allogeneic transplant.

Patients eligible for the study will be placed into one of two groups:

- Adjuvant (Group 1): Patients screened prior to their HSCT with CR without minimal
residual disease (CRMRD-) at 85-130 days post transplant will be randomized (1:1) in an
unblinded fashion to:

- MT-401 (Arm A)

- SOC (Arm B)

- Active Disease: (Group 2): Patients meeting the following criteria will be assigned to
Group 2 and will receive MT 401:

- Patients who experience relapse (patients with MRD [MRD+] or frank relapse) at or
prior to post-transplant Day 85-130

- Patients in Arm B of Group 1 (SOC) who develop relapse (MRD+ or frank relapse)
post-HSCT (crossover patients)

- Patients who do not consent prior to HSCT but are experiencing their first relapse
(MRD+ or frank relapse) and have the same donor available for manufacturing

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