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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04511130
Other study ID # MRKR-19-401
Secondary ID FD-R-7272
Status Active, not recruiting
Phase Phase 2
First received
Last updated
Start date October 14, 2020
Est. completion date July 2027

Study information

Verified date March 2024
Source Marker Therapeutics, Inc.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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).


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 information / eligibility

Status Active, not recruiting
Enrollment 180
Est. completion date July 2027
Est. primary completion date July 2024
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 85-130 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

Study Design


Intervention

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.

Locations

Country Name City State
United States Winship Cancer Institute of Emory University Atlanta Georgia
United States University of Alabama at Birmingham Birmingham Alabama
United States Montefiore Medical Center Bronx New York
United States University of Chicago Chicago Illinois
United States Cleveland Clinic Taussig Cancer Center Cleveland Ohio
United States City of Hope National Medical Center Duarte California
United States John Theurer Cancer Center at Hackensack UMC Hackensack New Jersey
United States Baylor College of Medicine Houston Texas
United States MD Anderson Cancer Center Houston Texas
United States University of Iowa Hospitals & Clinics Iowa City Iowa
United States Mayo Clinical Cancer Center-Florida Jacksonville Florida
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 Memorial Sloan Kettering Cancer Center New York New York
United States Weill Cornell Medicine | NewYork-Presbyterian New York New York
United States Mayo Clinic Cancer Center-Rochester Rochester Minnesota
United States Moffitt Cancer Center Tampa Florida

Sponsors (1)

Lead Sponsor Collaborator
Marker Therapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Safety Lead-In Number of participants with MT-401 Dose Limiting Toxicities (DLTs) Baseline through Cycle 1 (28 Days)
Primary Phase 2 Adjuvant Group Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause. Up to 24 months after the first participant is randomized
Primary Phase 2 Active Disease Group Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria Up to 12 months
Primary Phase 2 Active Disease Group Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause Up to 24 months
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