Spots Global Cancer Trial Database for Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
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Trial Identification
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
Study ID: NCT04511130
Interventions
Study Description
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).
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 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
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Locations
University of Alabama at Birmingham, Birmingham, Alabama, United States
City of Hope National Medical Center, Duarte, California, United States
Moores Cancer Center at University of Californa San Diego, La Jolla, California, United States
UCLA Department of Medicine, Los Angeles, California, United States
Yale Cancer Center, New Haven, Connecticut, United States
Mayo Clinical Cancer Center-Florida, Jacksonville, Florida, United States
Moffitt Cancer Center, Tampa, Florida, United States
Winship Cancer Institute of Emory University, Atlanta, Georgia, United States
University of Chicago, Chicago, Illinois, United States
University of Iowa Hospitals & Clinics, Iowa City, Iowa, United States
Mayo Clinic Cancer Center-Rochester, Rochester, Minnesota, United States
John Theurer Cancer Center at Hackensack UMC, Hackensack, New Jersey, United States
Montefiore Medical Center, Bronx, New York, United States
Weill Cornell Medicine | NewYork-Presbyterian, New York, New York, United States
Memorial Sloan Kettering Cancer Center, New York, New York, United States
Cleveland Clinic Taussig Cancer Center, Cleveland, Ohio, United States
Baylor College of Medicine, Houston, Texas, United States
MD Anderson Cancer Center, Houston, Texas, United States
Contact Details
Name: Mythili Koneru, MD, PhD
Affiliation: Marker Therapeutics
Role: STUDY_DIRECTOR
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