Summary

Eligibility
for people ages 18 years and up (full criteria)
Location
at UCLA UCSD
Dates
study started
estimated completion
Principal Investigator
by Divya Koura, MD (ucsd)Gary Shiller (ucla)
Headshot of Divya Koura
Divya Koura

Description

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 106 cells (flat dosing).

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

Details

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

Keywords

Acute Myeloid Leukemia Stem Cell Transplantation Leukemia Leukemia, Myeloid Leukemia, Myeloid, Acute MT-401 following HSCT MT-401 following relapse

Eligibility

You can join if…

Open to people ages 18 years and up

  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:
  2. Adjuvant therapy for AML (Group 1) at 90 days (±10 days) post-HSCT defined as patients with CRMRD; or
  3. Treatment for refractory/relapsed AML (first relapse post-HSCT) when disease occurs after transplant (Group 2) defined as
  4. First relapse (MRD+ or frank relapse) post-HSCT
  5. Patients in Arm 1B (SOC) who experience first relapse (MRD+ or frank relapse) post HSCT
  6. Safety Lead-in defined as patients who fit all the criteria for Group 2 only
  7. Are ≥18 years of age
  8. Karnofsky/Lansky score of ≥60
  9. Life expectancy ≥12 weeks
  10. Adequate blood, liver, and renal function
  11. Blood: Hemoglobin ≥7.0 g/dL (can be transfused)
  12. Liver: Bilirubin ≤2X upper limit of normal; aspartate aminotransferase ≤3X upper limit of normal
  13. Renal: Serum creatinine ≤2X upper limit of normal or measured or calculated creatinine clearance ≥45mL/min
  14. Patients are allowed to be on experimental conditioning regimens prior to transplant if no planned maintenance therapy post-transplant.
  15. 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

You CAN'T join if...

  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

Locations

  • Moores Cancer Center at University of Californa San Diego accepting new patients
    La Jolla California 92093 United States
  • UCLA Department of Medicine not yet accepting patients
    Los Angeles California 90095 United States
  • City of Hope National Medical Center accepting new patients
    Duarte California 91010 United States

Lead Scientists at University of California Health

  • Divya Koura, MD (ucsd)
    Associate Clinical Professor, Medicine, Vc-health Sciences-schools. Authored (or co-authored) 12 research publications
  • Gary Shiller (ucla)

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Marker Therapeutics, Inc.
ID
NCT04511130
Phase
Phase 2 research study
Study Type
Interventional
Participants
Expecting 172 study participants
Last Updated