Phase I/II Study of Engineered T Cell Receptor-Modified NK Cells Targeting PRAME in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Myeloid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06383572
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Lymphodepleting Chemotherapy
  • Myeloid Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • Cyclophosphamide — DRUG
    Given by IV
  • Fludarabine phosphate — DRUG
    Given by IV
  • Decitabine — DRUG
    Given by IV
  • Dexamethasone — DRUG
    Given by mouth

Study Details

To find a recommended dose of PRAME-TCR-NK cells that can be given to patients with AML or MDS.

Key Dates

Start date
Jun 26, 2024
Status verified
Dec 2025
Primary completion
Apr 1, 2027
Completion
Apr 1, 2029

Study Design

Enrollment
44 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1 (Dose Escalation and Dose Expansion)
    Participants will be assigned to a dose level of the NK cell treatment based on when you join this study. Up to 4 dose levels of the treatment will be tested. The first group of participants will receive the lowest dose level. Each new group will receive a higher dose than the group before it, if no intolerable side effects were seen. This will continue until the highest tolerable dose of the NK cell treatment is found.

Primary Outcome Measure

Safety and adverse events (AEs) [ Time Frame: Through study completion; an average of 1 year. ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
MD Anderson Cancer CenterHoustonTexas77030
Jeremy Ramdial, MD
[email protected]
713-745-0146
Jeremy Ramdial, MD (PRINCIPAL_INVESTIGATOR)

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By research site
MD Anderson Cancer Center· Houston, TX

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