Phase1 Basket Trial Of CAR.70-Engineered IL15-Transduced With TGFBR2 Knock Out Cord Blood-Derived NK Cells For Relapsed/Refractory Lymphoid Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07444632
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • Fludarabine — DRUG
    Given by IV
  • TGFBR2 KO CAR27/IL-15 NK cells — DRUG
    Given by IV
  • Cyclophosphamide — DRUG
    Given by IV

Study Details

This is a phase 1 basket trial of TGFBR2 KO CAR27/IL-15 NK cells after lymphodepleting chemotherapy for patients with R/R B-NHL, HL, T-NHL or B-ALL.

Key Dates

Start date
Aug 31, 2026
Status verified
May 2026
Primary completion
Sep 30, 2030
Completion
Sep 30, 2032

Study Design

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

Arms

  • Experimental: Cycle 1: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells
    Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.
  • Experimental: Cycle 2: Treatment with Fludarabine and Cyclophosphamide + TGFBR2 KO CAR27/IL-15 NK Cells
    Each treatment cycle will consist of lymphodepleting chemotherapy, followed by infusion of the TGFBR2 KO CAR27/IL-15 NK cells. Participants will be admitted to the inpatient service on day -6.

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
Yago Nieto, MD, PHD
713-794-1752
Yago Nieto, MD, PHD (PRINCIPAL_INVESTIGATOR)

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