Safety of MT-401-OTS in Patients With Relapsed AML or MDS

Part of paid clinical trials in Duarte, California.

Sponsor
Marker Therapeutics, Inc.
Study ID
NCT06552416
Phase
PHASE1
Status
Recruiting
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Conditions

  • Acute Myeloid Leukemia, in Relapse
  • MDS

Eligibility Criteria

Sex
ALL
Age
65 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • MT-401-OTS — DRUG
    MT-401-OTS is an off the shelf cellular therapy product given by IV infusion through either a peripheral or central line.

Study Details

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.

Key Dates

Start date
Jun 16, 2025
Status verified
Dec 2025
Primary completion
Sep 30, 2029
Completion
Sep 30, 2029

Study Design

Enrollment
40 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort -1
    50 × 106 cells flat dose, 1 dose infused on Day 0
  • Experimental: Cohort 1
    100 × 106 cells flat dose, 1 dose infused on Day 0
  • Experimental: Cohort 2
    200 × 106 cells flat dose, 1 dose infused on Day 0
  • Experimental: Cohort 3
    400 × 106 cells flat dose, 1 dose infused on Day 0
  • Experimental: Cohort 4 (optional)
    up to 400 × 106 cells flat dose TBD based on data from Cohorts 1-3; may include split dosing, dosing with or without lymphodepleting conditioning regimen, or dosing with or without HMA

Primary Outcome Measure

Safety of MT-401-OTS [ Time Frame: Through study completion. Approximately 5 years ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)DuarteCalifornia91006
Stephanie Kasten
[email protected]
626-215-2835
Shukaib Arslan, MD (PRINCIPAL_INVESTIGATOR)
Moffitt Cancer CenterTampaFlorida33612
Sarah Starr
[email protected]
813-745-2690
Nelli Bejanyan (PRINCIPAL_INVESTIGATOR)
KU Cancer CenterKansas CityKansas66160
Rafaela Nelson
[email protected]
913-945-9226
Haitham Abdelhakim (PRINCIPAL_INVESTIGATOR)

Find similar trials in Duarte, CA

By research site
City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)· Duarte, CAMoffitt Cancer Center· Tampa, FLKU Cancer Center· Kansas City, KS

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