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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04511130
Recruitment Status : Recruiting
First Posted : August 13, 2020
Last Update Posted : December 5, 2022
Sponsor:
Information provided by (Responsible Party):
Marker Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE July 30, 2020
First Posted Date  ICMJE August 13, 2020
Last Update Posted Date December 5, 2022
Actual Study Start Date  ICMJE October 14, 2020
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2020)
  • Safety Lead-In [ Time Frame: Baseline through Cycle 1 (28 Days) ]
    Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
  • Phase 2 Adjuvant Group [ Time Frame: 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.
  • Phase 2 Active Disease Group [ Time Frame: Up to 12 months ]
    Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
  • Phase 2 Active Disease Group [ Time Frame: 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
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
Official Title  ICMJE 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
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 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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE
  • Acute Myeloid Leukemia
  • Stem Cell Transplantation
Intervention  ICMJE 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.
Other Name: zedenoleucel
Study Arms  ICMJE
  • Experimental: MT-401 following HSCT
    Treatment with MT-401 at 90 days following HSCT
    Intervention: Drug: MT-401
  • No Intervention: Standard of Care following HSCT
    Standard of Care
  • Experimental: MT-401 following relapse
    Treatment with MT-401 following relapse after first HSCT
    Intervention: Drug: MT-401
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 10, 2020)
172
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 2027
Estimated Primary Completion Date July 2024   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Mythilli Koneru, MD, PhD 713.400.6400 mkoneru@markertherapeutics.com
Contact: Gerald Garrett 713.400.6400 ggarrett@markertherapeutics.com
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04511130
Other Study ID Numbers  ICMJE MRKR-19-401
FD-R-7272 ( Other Grant/Funding Number: Office of Orphan Products Development )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Marker Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Marker Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Mythili Koneru, MD, PhD Marker Therapeutics
PRS Account Marker Therapeutics, Inc.
Verification Date March 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP