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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511130
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : November 14, 2022
Sponsor:
Information provided by (Responsible Party):
Marker Therapeutics, Inc.

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Myeloid Leukemia Stem Cell Transplantation Drug: MT-401 Phase 2

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

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 172 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : October 14, 2020
Estimated Primary Completion Date : July 2024
Estimated Study Completion Date : July 2027


Arm Intervention/treatment
Experimental: MT-401 following HSCT
Treatment with MT-401 at 90 days following HSCT
Drug: MT-401
MT-401 (zedenoleucel) 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 Name: zedenoleucel

No Intervention: Standard of Care following HSCT
Standard of Care
Experimental: MT-401 following relapse
Treatment with MT-401 following relapse after first HSCT
Drug: MT-401
MT-401 (zedenoleucel) 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 Name: zedenoleucel




Primary Outcome Measures :
  1. Safety Lead-In [ Time Frame: Baseline through Cycle 1 (28 Days) ]
    Number of participants with MT-401 Dose Limiting Toxicities (DLTs)

  2. Phase 2 Adjuvant Group [ Time Frame: Up to 24 months after the first participant is randomized ]
    Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.

  3. Phase 2 Active Disease Group [ Time Frame: Up to 12 months ]
    Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria

  4. Phase 2 Active Disease Group [ Time Frame: Up to 24 months ]
    Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04511130


Contacts
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Contact: Mythilli Koneru, MD, PhD 713.400.6400 mkoneru@markertherapeutics.com
Contact: Gerald Garrett 713.400.6400 ggarrett@markertherapeutics.com

Locations
Show Show 18 study locations
Sponsors and Collaborators
Marker Therapeutics, Inc.
Investigators
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Study Director: Mythili Koneru, MD, PhD Marker Therapeutics
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Responsible Party: Marker Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04511130    
Other Study ID Numbers: MRKR-19-401
First Posted: August 13, 2020    Key Record Dates
Last Update Posted: November 14, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Leukemia
Leukemia, Myeloid
Leukemia, Myeloid, Acute
Neoplasms by Histologic Type
Neoplasms