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).
Brief Title
Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant
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
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
Categories
Completion Date
Completion Date Type
Actual
Conditions
Acute Myeloid Leukemia
Stem Cell Transplantation
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 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
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
Inclusion 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 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
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
Gender
All
Gender Based
false
Healthy Volunteers
No
Last Update Post Date
Last Update Post Date Type
Actual
Last Update Submit Date
Minimum Age
18 Years
NCT Id
NCT04511130
Org Class
Industry
Org Full Name
Marker Therapeutics, Inc.
Org Study Id
MRKR-19-401
Overall Status
Completed
Phases
Phase 2
Primary Completion Date
Primary Completion Date Type
Actual
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
Primary Outcomes
Outcome Description
Number of participants with MT-401 Dose Limiting Toxicities (DLTs)
Outcome Measure
Safety Lead-In
Outcome Time Frame
Baseline through Cycle 1 (28 Days)
Outcome Description
Relapse Free Survival (RFS), defined as the time from randomization to first disease recurrence or death from any cause.
Outcome Measure
Phase 2 Adjuvant Group
Outcome Time Frame
Up to 24 months after the first participant is randomized
Outcome Description
Complete Remission (CR), per European LeukemiaNet (ELN) 2017 criteria
Outcome Measure
Phase 2 Active Disease Group
Outcome Time Frame
Up to 12 months
Outcome Description
Duration of CR (DOCR), defined as the time from the first observation of CR through disease recurrence or death from any cause
Outcome Measure
Phase 2 Active Disease Group
Outcome Time Frame
Up to 24 months
Secondary Ids
Secondary Id
FD-R-7272
Start Date
Start Date Type
Actual
Status Verified Date
First Post Date
First Post Date Type
Actual
First Submit Date
First Submit QC Date
Std Ages
Adult
Older Adult
Maximum Age Number (converted to Years and rounded down)
999
Minimum Age Number (converted to Years and rounded down)
18
Investigators
Investigator Type
Principal Investigator
Investigator Name
Roberto Alejandro Sica
Investigator Email
asica@montefiore.org
Categories Mesh Debug
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID, ACUTE
Blood & Bone Marrow Cancers --- LEUKEMIA, MYELOID
Cancer --- LEUKEMIA
Blood & Bone Marrow Cancers --- LEUKEMIA
Cancer --- NEOPLASMS
Blood Disorders --- HEMATOLOGIC DISEASES
Blood & Bone Marrow Cancers --- HEMATOLOGIC DISEASES
MeSH Terms
LEUKEMIA, MYELOID, ACUTE
LEUKEMIA, MYELOID
LEUKEMIA
NEOPLASMS BY HISTOLOGIC TYPE
NEOPLASMS
HEMATOLOGIC DISEASES
HEMIC AND LYMPHATIC DISEASES