Title

Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation
  • Phase

    Phase 2
  • Study Type

    Interventional
  • Status

    Recruiting
  • Intervention/Treatment

    MT-401
  • Study Participants

    172
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).
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 90 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 90
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
Study Started
Oct 14
2020
Primary Completion
Jul 31
2022
Anticipated
Study Completion
Jul 31
2027
Anticipated
Last Update
Jun 03
2022

Drug MT-401

MT-401 (zelenoleucel) is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells obtained from apheresis.

  • Other names: zelenoleucel

MT-401 following HSCT Experimental

Treatment with MT-401 at 90 days following HSCT

Standard of Care following HSCT No Intervention

Standard of Care

MT-401 following relapse Experimental

Treatment with MT-401 following relapse after first HSCT

Criteria

Inclusion Criteria

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:

Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD; or

Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as

First relapse (MRD+ or frank relapse) post-HSCT
Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
Safety Lead-in defined as patients who fit all the criteria for Group 2 only
Are ≥18 years of age
Karnofsky/Lansky score of ≥60
Life expectancy ≥12 weeks

Adequate blood, liver, and renal function

Blood: Hemoglobin ≥7.0 g/dL (can be transfused)
Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal
Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min

7. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.

8. 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

Exclusion Criteria

Clinically significant or severely symptomatic intercurrent infection
Pregnant or lactating
For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401
For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
Evidence of acute or chronic GVHD ≥Grade 2 (exception: acute or chronic Grade 2 GVHD of skin allowed if stable) within one week prior to receiving MT-401
No Results Posted