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

Status
Active
Cancer Type
Leukemia
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT04511130
Protocol IDs
MRKR-19-401 (primary)
NCI-2020-07647
Study Sponsor
Marker Therapeutics

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

Eligibility

  1. First allogeneic HSCT, in = CR2, and MRD negative prior to transplant (including matched sibling, MUD with at least 6 of 8 HLA markers, or haploidentical with at least 5 of 10 HLA markers) as:
  2. Adjuvant therapy for AML (Group 1) at 85-130 days post-HSCT defined as patients with CRMRD; or
  3. Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
  4. First relapse (MRD+ or frank relapse) post-HSCT
  5. Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
  6. Safety Lead-in defined as patients who fit all the criteria for Group 2 only
  7. Are =18 years of age
  8. Karnofsky/Lansky score of =60
  9. Life expectancy =12 weeks
  10. Adequate blood, liver, and renal function
  11. Blood: Hemoglobin =7.0 g/dL (can be transfused)
  12. Liver: Bilirubin =2X upper limit of normal; aspartate aminotransferase =3X upper limit of normal
  13. Renal: Serum creatinine =2X upper limit of normal or measured or calculated creatinine clearance =45mL/min
  14. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.
  15. In Group 2, patients may receive bridging therapy at the investigators' discretion in situations where MT-401 is not ready for administration or the treating physician believes the patient would benefit
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