A Phase I/II Study of CAR.70-Engineered IL15-Transduced Cord Blood-Derived NK Cells With TGF-beta Receptor 2 (TGFBR2) Knock Out in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Myeloid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT06930651
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Myeloid Malignancies

Eligibility Criteria

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

Interventions

  • Dexamethasone — DRUG
    Given Orally
  • Cyclophosphamide — DRUG
    Given by IV
  • Fludarabine — DRUG
    Given by IV
  • Decitabine — DRUG
    Given by IV
  • TGFBR2 KO CAR27/IL-15 NK cells — BIOLOGICAL
    Given by Infusion

Study Details

The goal of this clinical research study is to find the recommended safe dose of TGFBR2 KO CAR27/IL-15 NK cells that can be given to patients with relapsed/refractory disease. The safety and effectiveness of this treatment will also be studied.

Key Dates

Start date
Sep 3, 2025
Status verified
May 2026
Primary completion
May 1, 2028
Completion
May 1, 2030

Study Design

Enrollment
42 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Phase 1: Dose Escalation with CAR.70
    Participants will receive lymphodepleting and primary chemotherapy, followed by a one-time infusion of TGFR KO-CAR27/IL-15 NK cells. Dose of the cells will be a different dose until a maximum tolerated dose is found.
  • Experimental: Phase 2A: Dose Expansion with CAR.70 for AML Patients
    Participants will receive lymphodepleting and primary chemotherapy, followed by a one-time infusion of TGFR KO-CAR27/IL-15 NK cells using the maximum tolerated dose found in escalation

Primary Outcome Measure

Safety and Adverse Events (AEs) [ Time Frame: Through study completion; an average of 1 year ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
The University of Texas M. D. Anderson Cancer CenterHoustonTexas77030
Nicholas Short, MD
[email protected]
713-563-4485
Nicholas Short, MD (PRINCIPAL_INVESTIGATOR)

Find similar trials in Houston, TX

By research site
The University of Texas M. D. Anderson Cancer Center· Houston, TX

Related Studies