Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : June 3, 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

Layout table for study information
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 2022
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 (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 Name: zelenoleucel

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 (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 Name: zelenoleucel




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

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
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
Layout table for location contacts
Contact: Mythilli Koneru, MD, PhD 713.400.6400 mkoneru@markertherapeutics.com
Contact: Gerald Garrett 713.400.6400 ggarrett@markertherapeutics.com

Locations
Layout table for location information
United States, Alabama
University of Alabama at Birmingham Recruiting
Birmingham, Alabama, United States, 35249
Contact: Antonio Di Staci, MD    205-801-8415    adistasi@uabmc.edu   
Contact: Lindsey Stephens, RN    205.975.2028    lmeggs@uabmc.edu   
Principal Investigator: Antonio Di Staci, MD         
United States, California
City of Hope National Medical Center Recruiting
Duarte, California, United States, 91010
Contact: Shukaib Arslan, MD    877-467-3411    sarslan@coh.org   
Principal Investigator: Shukaib Arslan, MD         
Moores Cancer Center at University of Californa San Diego Recruiting
La Jolla, California, United States, 92093
Contact: Michelle Padilla    858-822-5223    mlp002@health.ucsd.edu   
Principal Investigator: Divya Koura, MD         
UCLA Department of Medicine Not yet recruiting
Los Angeles, California, United States, 90095
Contact: Vladimir kustanovich    310-206-5756    VKustanovich@mednet.ucla.edu   
Principal Investigator: Gary Shiller, MD         
United States, Connecticut
Yale Cancer Center Recruiting
New Haven, Connecticut, United States, 06519
Contact: Alexandra Dormal    203-737-4839    alexandra.dormal@yale.edu   
Principal Investigator: Iris Isufi, MD         
United States, Florida
Moffitt Cancer Center Recruiting
Tampa, Florida, United States, 33612
Contact: Maria Urdiales    813-745-1218    Maria.Urdiales@moffitt.org   
Contact: Michelle Burton, RN    813.745.1537    Michelle.Burton@moffitt.org   
Principal Investigator: Nelli Bejanyan, MD         
United States, Georgia
Winship Cancer Institute of Emory University Recruiting
Atlanta, Georgia, United States, 303222
Contact: Ashley Trumbull    404-778-3969    ashley.lynn.trumbull@emory.edu   
Contact: Corey Williams    404-251-2014    williams2@emory.edu   
Principal Investigator: William Blum, MD         
United States, Illinois
University of Chicago Recruiting
Chicago, Illinois, United States, 77027
Contact: Hongtao Liu, MD    773-702-0589    hliu2@medicine.bsd.uchicago.edu   
Principal Investigator: Hongtao Liu, MD         
United States, Iowa
University of Iowa Hospitals & Clinics Recruiting
Iowa City, Iowa, United States, 52242
Contact: Margarida Silverman, MD    319-356-1616    margarida-silverman@uiowa.edu   
Contact: Karen Parrott, RN    319.353.6347    karen-parrott@uiowa.edu   
Principal Investigator: Margarida Silverman, MD         
United States, New Jersey
John Theurer Cancer Center at Hackensack UMC Recruiting
Hackensack, New Jersey, United States, 07601
Contact: Andrew McConnel    551-996-5949    Andrew.mcconnell@hmhn.org   
Principal Investigator: Michele Donato, MD         
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Markenya Mirander       mmirande@montefiore.org   
Contact: Joel Victor       jovictor@montefiore.org   
Principal Investigator: Alejandro Sica, MD         
Weill Cornell Medicine | NewYork-Presbyterian Recruiting
New York, New York, United States, 10021
Contact: Raymond Mitto    917-755-0286    am9073@med.cornell.edu   
Contact: Alina Surkanova       als2086@med.cornell.edu   
Principal Investigator: Jing-Mei Hsu, MD         
Memorial Sloan Kettering Cancer Center Recruiting
New York, New York, United States, 10065
Contact: Daniella Burnetta       burnetd2@mskcc.org   
Contact: Theresa Elko, MPAS, PA-C    646.608.3851 ext pager 3456      
Principal Investigator: Boglarka Gyurkocza, MD         
United States, Ohio
Cleveland Clinic Taussig Cancer Center Recruiting
Cleveland, Ohio, United States, 44195
Contact: Nicolette Steigerwald    440-773-4810    STEIGEN@ccf.org   
Principal Investigator: Ronald Sobecks, MD         
United States, Texas
Baylor College of Medicine Recruiting
Houston, Texas, United States, 77030
Contact: Catherine Robertson    832-824-5494    csrobert@texaschildrens.org   
Principal Investigator: Premal Lulla, MD         
MD Anderson Cancer Center Recruiting
Houston, Texas, United States, 77030
Contact: Jessica M McCarty    713-745-5228    jmmccarty@mdanderson.org   
Principal Investigator: Betul Oran, MD         
Sponsors and Collaborators
Marker Therapeutics, Inc.
Investigators
Layout table for investigator information
Study Director: Mythili Koneru, MD, PhD Marker Therapeutics
Layout table for additonal information
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: June 3, 2022
Last Verified: March 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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