Actively Recruiting
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Led by Marker Therapeutics, Inc. · Updated on 2025-12-16
40
Participants Needed
3
Research Sites
219 weeks
Total Duration
On this page
Sponsors
M
Marker Therapeutics, Inc.
Lead Sponsor
U
University of Kansas Medical Center
Collaborating Sponsor
AI-Summary
What this Trial Is About
This study is a Phase 1 multicenter, open-label study evaluating the safety and efficacy of escalating doses of MT-401-OTS in 2 participant populations: 1) Those with intermediate or high-risk AML per 2022 ELN criteria who have evidence of MRD and/or \</= 10% blast following prior induction therapy or at least 4 cycles of nonintensive therapy and 2) those with high- or very-high-risk MDS per 2023 IWG criteria and who have residual disease with \</= 10% blasts following treatment with an HMA-based therapy.
CONDITIONS
Official Title
Safety of MT-401-OTS in Patients With Relapsed AML or MDS
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 65 years of age or older and able to give informed consent
- Life expectancy of at least 12 weeks
- ECOG performance status between 0 and 2
- Available MT-401-OTS product with at least a 2/8 HLA match
- For AML patients: confirmed diagnosis per 2022 WHO or ICC criteria
- Intermediate or high-risk AML by 2022 ELN criteria
- Prior standard therapy including at least 4 cycles of HMA or cytarabine induction if no targetable mutation
- If targetable mutation present, received targeted therapy unless intolerant or declined
- Bone marrow blasts ≤10% and peripheral blasts ≤5% or evidence of minimal residual disease
- For MDS patients: confirmed diagnosis per 2022 WHO or ICC criteria
- High-risk or very-high-risk MDS by IPSS-M, not evolved to AML
- Received at least 4 cycles of HMA with evidence of persistent disease
- Bone marrow blasts ≤10% at screening
- Adequate coagulation, liver, kidney, and heart function meeting specified lab criteria
- Women of childbearing potential agree to use highly effective contraception and not donate eggs during and for 1 year after treatment
- Male participants agree to refrain from sperm donation and use contraception or abstinence during and for 6 months after treatment
You will not qualify if you...
- Leukemic involvement in the central nervous system
- Extramedullary disease except hepatosplenic involvement
- Acute promyelocytic leukemia
- Primary immunodeficiency
- Severe or uncontrolled autoimmune disorders
- Clinically relevant CNS pathology including epilepsy, stroke, dementia, psychosis, etc.
- Active malignancies progressing or treated within last 24 months, with some exceptions
- Active systemic infections including HIV
- Active hepatitis B or C infection or other active liver diseases
- Class III or IV congestive heart failure
- Unstable angina or uncontrolled arrhythmias
- Oxygen saturation ≤92% on room air
- Significant nonhematologic toxicities from prior therapy not recovered to baseline
- Prior treatments not allowed except specified in inclusion
- Prior hematopoietic stem cell transplant
- Concurrent therapies other than HMA as per study design
- Hematopoietic growth factors within 2 days of lymphodepletion
- Severe allergies or intolerance to study interventions or components
- Major surgery within 14 days (except central line placement)
- Systemic steroids or immunosuppressive therapies within 14 days prior to lymphodepletion
- Unable to be matched with MT-401-OTS product
- Pregnant or breastfeeding
- Any other condition making participation or compliance unsuitable per physician judgment
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)
Duarte, California, United States, 91006
Actively Recruiting
2
Moffitt Cancer Center
Tampa, Florida, United States, 33612
Actively Recruiting
3
KU Cancer Center
Kansas City, Kansas, United States, 66160
Actively Recruiting
Research Team
P
Patricia Allison, BS
CONTACT
B
Beth Lepping, BSN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
5
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