Acute Myeloid Leukemia Clinical Trial
— ARTEMISOfficial 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
Verified date | March 2024 |
Source | Marker Therapeutics, Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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).
Status | Active, not recruiting |
Enrollment | 180 |
Est. completion date | July 2027 |
Est. primary completion date | July 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | 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 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 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 |
Country | Name | City | State |
---|---|---|---|
United States | Winship Cancer Institute of Emory University | Atlanta | Georgia |
United States | University of Alabama at Birmingham | Birmingham | Alabama |
United States | Montefiore Medical Center | Bronx | New York |
United States | University of Chicago | Chicago | Illinois |
United States | Cleveland Clinic Taussig Cancer Center | Cleveland | Ohio |
United States | City of Hope National Medical Center | Duarte | California |
United States | John Theurer Cancer Center at Hackensack UMC | Hackensack | New Jersey |
United States | Baylor College of Medicine | Houston | Texas |
United States | MD Anderson Cancer Center | Houston | Texas |
United States | University of Iowa Hospitals & Clinics | Iowa City | Iowa |
United States | Mayo Clinical Cancer Center-Florida | Jacksonville | Florida |
United States | Moores Cancer Center at University of Californa San Diego | La Jolla | California |
United States | UCLA Department of Medicine | Los Angeles | California |
United States | Yale Cancer Center | New Haven | Connecticut |
United States | Memorial Sloan Kettering Cancer Center | New York | New York |
United States | Weill Cornell Medicine | NewYork-Presbyterian | New York | New York |
United States | Mayo Clinic Cancer Center-Rochester | Rochester | Minnesota |
United States | Moffitt Cancer Center | Tampa | Florida |
Lead Sponsor | Collaborator |
---|---|
Marker Therapeutics, Inc. |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Safety Lead-In | Number of participants with MT-401 Dose Limiting Toxicities (DLTs) | Baseline through Cycle 1 (28 Days) | |
Primary | Phase 2 Adjuvant Group | Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause. | Up to 24 months after the first participant is randomized | |
Primary | Phase 2 Active Disease Group | Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria | Up to 12 months | |
Primary | 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 | Up to 24 months |
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