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

• Sponsor: Marker Therapeutics, Inc. (Industry)
• Overall Status: Recruiting
• CT.gov ID: NCT04511130
• Collaborator: (none)
• Enrollment: 172
• Locations: 16
• Arms: 3
• Anticipated Duration (Months): 80.5
• Patients Per Site: 10.8
• Patients Per Site Per Month: 0.1

Study Details

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).

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

Study Design

• Study Type: Interventional
• Anticipated 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: Oct 14, 2020
• Anticipated Primary Completion Date: Jul 1, 2024
• Anticipated Study Completion Date: Jul 1, 2027

Arms and Interventions

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 Names: 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 Names: zelenoleucel

Outcome Measures

Primary Outcome Measures

1. Safety Lead-In [Baseline through Cycle 1 (28 Days)]

   Number of participants with MT-401 Dose Limiting Toxicities (DLTs)

2. 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.

3. Phase 2 Active Disease Group [Up to 12 months]

   Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria

4. 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

1. Are ≥18 years of age

2. Karnofsky/Lansky score of ≥60

3. Life expectancy ≥12 weeks

4. 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

1. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.

2. 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of Alabama at Birmingham	Birmingham	Alabama	United States	35249
2	City of Hope National Medical Center	Duarte	California	United States	91010
3	Moores Cancer Center at University of Californa San Diego	La Jolla	California	United States	92093
4	UCLA Department of Medicine	Los Angeles	California	United States	90095
5	Yale Cancer Center	New Haven	Connecticut	United States	06519
6	Moffitt Cancer Center	Tampa	Florida	United States	33612
7	Winship Cancer Institute of Emory University	Atlanta	Georgia	United States	303222
8	University of Chicago	Chicago	Illinois	United States	77027
9	University of Iowa Hospitals & Clinics	Iowa City	Iowa	United States	52242
10	John Theurer Cancer Center at Hackensack UMC	Hackensack	New Jersey	United States	07601
11	Montefiore Medical Center	Bronx	New York	United States	10467
12	Weill Cornell Medicine | NewYork-Presbyterian	New York	New York	United States	10021
13	Memorial Sloan Kettering Cancer Center	New York	New York	United States	10065
14	Cleveland Clinic Taussig Cancer Center	Cleveland	Ohio	United States	44195
15	Baylor College of Medicine	Houston	Texas	United States	77030
16	MD Anderson Cancer Center	Houston	Texas	United States	77030

Sponsors and Collaborators

• Marker Therapeutics, Inc.

Investigators

• Study Director: Mythili Koneru, MD, PhD, Marker Therapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marker Therapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04511130
• Other Study ID Numbers: MRKR-19-401
• First Posted: Aug 13, 2020
• Last Update Posted: Aug 24, 2022
• Last Verified: Mar 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Leukemia; Leukemia, Myeloid; Leukemia, Myeloid, Acute

Study Results

No Results Posted as of Aug 24, 2022