Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
- Registration Number
- NCT04511130
- Lead Sponsor
- 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).
- 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
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 92
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description MT-401 following HSCT MT-401 Treatment with MT-401 at 90 days following HSCT MT-401 following relapse MT-401 Treatment with MT-401 following relapse after first HSCT
- Primary Outcome Measures
Name Time Method Safety Lead-In Baseline through Cycle 1 (28 Days) Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Phase 2 Active Disease Group 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
Phase 2 Adjuvant Group 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
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
Scroll for more (8 remaining)University of Alabama at Birmingham🇺🇸Birmingham, Alabama, United States