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

Acute Myeloid Leukemia Clinical Trial

— ARTEMIS  

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

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
• 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
• 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

Related Conditions & MeSH terms

• Acute Myeloid Leukemia
• Leukemia
• Leukemia, Myeloid
• Leukemia, Myeloid, Acute
• Stem Cell Transplantation

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