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

Primary Purpose

Acute Myeloid Leukemia, Stem Cell Transplantation

Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
MT-401
Sponsored by
Marker Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Myeloid Leukemia

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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
  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

Sites / Locations

  • University of Alabama at BirminghamRecruiting
  • City of Hope National Medical CenterRecruiting
  • Moores Cancer Center at University of Californa San DiegoRecruiting
  • UCLA Department of MedicineRecruiting
  • Yale Cancer CenterRecruiting
  • Mayo Clinical Cancer Center-FloridaRecruiting
  • Moffitt Cancer CenterRecruiting
  • Winship Cancer Institute of Emory UniversityRecruiting
  • University of ChicagoRecruiting
  • University of Iowa Hospitals & ClinicsRecruiting
  • Mayo Clinic Cancer Center-RochesterRecruiting
  • John Theurer Cancer Center at Hackensack UMCRecruiting
  • Montefiore Medical CenterRecruiting
  • Weill Cornell Medicine | NewYork-PresbyterianRecruiting
  • Memorial Sloan Kettering Cancer CenterRecruiting
  • Cleveland Clinic Taussig Cancer CenterRecruiting
  • Baylor College of MedicineRecruiting
  • MD Anderson Cancer CenterRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Experimental

Arm Label

MT-401 following HSCT

Standard of Care following HSCT

MT-401 following relapse

Arm Description

Treatment with MT-401 at 90 days following HSCT

Standard of Care

Treatment with MT-401 following relapse after first HSCT

Outcomes

Primary Outcome Measures

Safety Lead-In
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Phase 2 Adjuvant Group
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
Phase 2 Active Disease Group
Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
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

Secondary Outcome Measures

Full Information

First Posted
July 30, 2020
Last Updated
March 20, 2023
Sponsor
Marker Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04511130
Brief Title
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
Acronym
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
Study Type
Interventional

2. Study Status

Record Verification Date
March 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 14, 2020 (Actual)
Primary Completion Date
July 2024 (Anticipated)
Study Completion Date
July 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Marker Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. 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).
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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Myeloid Leukemia, Stem Cell Transplantation

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
180 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
MT-401 following HSCT
Arm Type
Experimental
Arm Description
Treatment with MT-401 at 90 days following HSCT
Arm Title
Standard of Care following HSCT
Arm Type
No Intervention
Arm Description
Standard of Care
Arm Title
MT-401 following relapse
Arm Type
Experimental
Arm Description
Treatment with MT-401 following relapse after first HSCT
Intervention Type
Drug
Intervention Name(s)
MT-401
Other Intervention Name(s)
zedenoleucel
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety Lead-In
Description
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Time Frame
Baseline through Cycle 1 (28 Days)
Title
Phase 2 Adjuvant Group
Description
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
Time Frame
Up to 24 months after the first participant is randomized
Title
Phase 2 Active Disease Group
Description
Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
Time Frame
Up to 12 months
Title
Phase 2 Active Disease Group
Description
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
Time Frame
Up to 24 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria 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 Are ≥18 years of age Karnofsky/Lansky score of ≥60 Life expectancy ≥12 weeks 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 Clinically significant or severely symptomatic intercurrent infection Pregnant or lactating For Group 1, anti-neoplastic therapy after HSCT and prior to or during dosing of MT-401 For Group 2, concomitant anti-neoplastic therapy during or after dosing of MT-401 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mythilli Koneru, MD, PhD
Phone
713.400.6400
Email
mkoneru@markertherapeutics.com
First Name & Middle Initial & Last Name or Official Title & Degree
Gerald Garrett
Phone
713.400.6400
Email
ggarrett@markertherapeutics.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Mythili Koneru, MD, PhD
Organizational Affiliation
Marker Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Antonio Di Staci, MD
Phone
205-801-8415
Email
adistasi@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Lindsey Stephens, RN
Phone
205.975.2028
Email
lmeggs@uabmc.edu
First Name & Middle Initial & Last Name & Degree
Antonio Di Staci, MD
Facility Name
City of Hope National Medical Center
City
Duarte
State/Province
California
ZIP/Postal Code
91010
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Shukaib Arslan, MD
Phone
877-467-3411
Email
sarslan@coh.org
First Name & Middle Initial & Last Name & Degree
Shukaib Arslan, MD
Facility Name
Moores Cancer Center at University of Californa San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michelle Padilla
Phone
858-822-5223
Email
mlp002@health.ucsd.edu
First Name & Middle Initial & Last Name & Degree
Divya Koura, MD
Facility Name
UCLA Department of Medicine
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vladimir kustanovich
Phone
310-206-5756
Email
VKustanovich@mednet.ucla.edu
First Name & Middle Initial & Last Name & Degree
Gary Shiller, MD
Facility Name
Yale Cancer Center
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alexandra Dormal
Phone
203-737-4839
Email
alexandra.dormal@yale.edu
First Name & Middle Initial & Last Name & Degree
Iris Isufi, MD
Facility Name
Mayo Clinical Cancer Center-Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tammy Bicknese
Phone
507-266-6841
Email
Bicknese.Tammy@mayo.edu
First Name & Middle Initial & Last Name & Degree
Hemant Murthy, MD
Facility Name
Moffitt Cancer Center
City
Tampa
State/Province
Florida
ZIP/Postal Code
33612
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Maria Urdiales
Phone
813-745-1218
Email
Maria.Urdiales@moffitt.org
First Name & Middle Initial & Last Name & Degree
Michelle Burton, RN
Phone
813.745.1537
Email
Michelle.Burton@moffitt.org
First Name & Middle Initial & Last Name & Degree
Nelli Bejanyan, MD
Facility Name
Winship Cancer Institute of Emory University
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
303222
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ashley Trumbull
Phone
404-778-3969
Email
ashley.lynn.trumbull@emory.edu
First Name & Middle Initial & Last Name & Degree
Corey Williams
Phone
404-251-2014
Email
williams2@emory.edu
First Name & Middle Initial & Last Name & Degree
William Blum, MD
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
77027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hongtao Liu, MD
Phone
773-702-0589
Email
hliu2@medicine.bsd.uchicago.edu
First Name & Middle Initial & Last Name & Degree
Hongtao Liu, MD
Facility Name
University of Iowa Hospitals & Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Margarida Silverman, MD
Phone
319-356-1616
Email
margarida-silverman@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Karen Parrott, RN
Phone
319.353.6347
Email
karen-parrott@uiowa.edu
First Name & Middle Initial & Last Name & Degree
Margarida Silverman, MD
Facility Name
Mayo Clinic Cancer Center-Rochester
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mary Glatzmaier
Phone
507-422-4269
Email
Glatzmaier.Mary@mayo.edu
First Name & Middle Initial & Last Name & Degree
Shag Mithun, MD
Facility Name
John Theurer Cancer Center at Hackensack UMC
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Andrew McConnel
Phone
551-996-5949
Email
Andrew.mcconnell@hmhn.org
First Name & Middle Initial & Last Name & Degree
Michele Donato, MD
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Markenya Mirander
Email
mmirande@montefiore.org
First Name & Middle Initial & Last Name & Degree
Joel Victor
Email
jovictor@montefiore.org
First Name & Middle Initial & Last Name & Degree
Alejandro Sica, MD
Facility Name
Weill Cornell Medicine | NewYork-Presbyterian
City
New York
State/Province
New York
ZIP/Postal Code
10027
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Danielle Guarneri
Phone
212-746-0974
Email
dag2037@med.cornell.edu
First Name & Middle Initial & Last Name & Degree
Sebastian Mayer, MD
Facility Name
Memorial Sloan Kettering Cancer Center
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Daniella Burnetta
Email
burnetd2@mskcc.org
First Name & Middle Initial & Last Name & Degree
Theresa Elko, MPAS, PA-C
Phone
646.608.3851
Ext
pager 3456
First Name & Middle Initial & Last Name & Degree
Boglarka Gyurkocza, MD
Facility Name
Cleveland Clinic Taussig Cancer Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Nicolette Steigerwald
Phone
440-773-4810
Email
STEIGEN@ccf.org
First Name & Middle Initial & Last Name & Degree
Ronald Sobecks, MD
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Robertson
Phone
832-824-5494
Email
csrobert@texaschildrens.org
First Name & Middle Initial & Last Name & Degree
Premal Lulla, MD
Facility Name
MD Anderson Cancer Center
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jessica M McCarty
Phone
713-745-5228
Email
jmmccarty@mdanderson.org
First Name & Middle Initial & Last Name & Degree
Betul Oran, MD

12. IPD Sharing Statement

Plan to Share IPD
No

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

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