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

• ClinicalTrials.gov Identifier: NCT04511130
• Recruitment Status: Recruiting
• First Posted: August 13, 2020
• Last Update Posted: December 5, 2022
• Sponsor: Marker Therapeutics, Inc.
• Information provided by (Responsible Party): Marker Therapeutics, Inc.

Tracking Information

• First Submitted Date: July 30, 2020
• First Posted Date: August 13, 2020
• Last Update Posted Date: December 5, 2022
• Actual Study Start Date: October 14, 2020
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (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: Same as current
• Current Secondary Outcome Measures: Not Provided
• Original Secondary Outcome Measures: Not Provided
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
• 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
• 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: Interventional
• Study Phase: Phase 2
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: None (Open Label); Primary Purpose: Treatment

Condition

• Acute Myeloid Leukemia
• 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.

Other Name: zedenoleucel

Study Arms

• 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

Recruitment Information

• Recruitment Status: Recruiting
• Estimated Enrollment (submitted: August 10, 2020): 172
• Original Estimated Enrollment: Same as current
• Estimated Study Completion Date: July 2027
• Estimated Primary Completion Date: July 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

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

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Contacts

Contact: Mythilli Koneru, MD, PhD; 713.400.6400; mkoneru@markertherapeutics.com

Contact: Gerald Garrett; 713.400.6400; ggarrett@markertherapeutics.com

• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT04511130
• Other Study ID Numbers: 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

• Plan to Share IPD: No

• Current Responsible Party: Marker Therapeutics, Inc.
• Original Responsible Party: Same as current
• Current Study Sponsor: Marker Therapeutics, Inc.
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

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

• PRS Account: Marker Therapeutics, Inc.
• Verification Date: March 2022