Clinical Trials /

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

NCT04511130

Description:

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).

Related Conditions:
  • Acute Myeloid Leukemia
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
  • Official Title: 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

Clinical Trial IDs

  • ORG STUDY ID: MRKR-19-401
  • NCT ID: NCT04511130

Conditions

  • Acute Myeloid Leukemia
  • Stem Cell Transplantation

Interventions

DrugSynonymsArms
MT-401zelenoleucelMT-401 following HSCT

Purpose

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).

Detailed Description

      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
    

Trial Arms

NameTypeDescriptionInterventions
MT-401 following HSCTExperimentalTreatment with MT-401 at 90 days following HSCT
  • MT-401
Standard of Care following HSCTNo InterventionStandard of Care
    MT-401 following relapseExperimentalTreatment with MT-401 following relapse after first HSCT
    • MT-401

    Eligibility Criteria

            Inclusion Criteria
    
              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:
    
                   -  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
    
              2. Are ≥18 years of age
    
              3. Karnofsky/Lansky score of ≥60
    
              4. Life expectancy ≥12 weeks
    
              5. 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
    
              1. Clinically significant or severely symptomatic intercurrent infection
    
              2. Pregnant or lactating
    
              3. For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of
                 MT-401
    
              4. For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401
    
              5. 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
          
    Maximum Eligible Age:N/A
    Minimum Eligible Age:18 Years
    Eligible Gender:All
    Healthy Volunteers:No

    Primary Outcome Measures

    Measure:Safety Lead-In
    Time Frame:Baseline through Cycle 1 (28 Days)
    Safety Issue:
    Description:Number of participants with MT-401 Dose Limiting Toxicities (DLTs)

    Details

    Phase:Phase 2
    Primary Purpose:Interventional
    Overall Status:Recruiting
    Lead Sponsor:Marker Therapeutics, Inc.

    Last Updated

    April 22, 2021