Phase II Study of CD5 CAR Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Aggressive T Cell Hematological Malignancies

Part of paid clinical trials in Houston, Texas.

Sponsor
M.D. Anderson Cancer Center
Study ID
NCT07137481
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

  • Hematological Malignancies

Eligibility Criteria

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

Interventions

  • C9/CD5CAR/IL-15 NK cells — DRUG
    Given PO or IV
  • Rituximab — DRUG
    Given by IV
  • Fludarabine — DRUG
    Given by IV
  • Cyclophosphamide — DRUG
    Given by IV

Study Details

To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.

Key Dates

Start date
Feb 28, 2027
Status verified
Mar 2026
Primary completion
Jul 31, 2030
Completion
Jul 31, 2032

Study Design

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

Arms

  • Experimental: Cohort 1 and Cohort 2: Treatment with Rituximab + iC9/CD5CAR/IL-15 NK Cells
    Participants will recived treatment on an inpatient/outpatient basis at PI's discretion

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
Chitra Hosing, MD
[email protected]
713-745-3219
Chitra Hosing, MD (PRINCIPAL_INVESTIGATOR)

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

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