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
M.D. Anderson Cancer Center
Summary
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.
Description
Primary Objective: 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. Secondary Objectives: To assess overall survival at 1 year. To quantify persistence of infused allogeneic donor iC9/CD5CAR/IL-15 NK cells in the recipient. To conduct comprehensive immune reconstitution studies. To establish the safety of this treatment.
Eligibility
- Age range
- 18–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion Criteria: 1. 18-80 years of age 2. Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry. 3. Patients must meet disease-specific eligibility criteria. a. Patients with a history of T-lymphoid malignancies, defined as T cell acute lymphoblastic leukemia/lymphoma (T-ALL/T-LBL), T-PLL, Peripheral T-cell lymphoma (PTCL-NOS), Hepatosplenic gamma/delta NHL, AITL, Alk negative/ DUSP22 negative ALCL, or other subtypes of T cell NHL with indication for autologous or allogeneic transplant in CR-1…
Interventions
- DrugC9/CD5CAR/IL-15 NK cells
Given PO or IV
- DrugRituximab
Given by IV
- DrugFludarabine
Given by IV
- DrugCyclophosphamide
Given by IV
Location
- The University of Texas M. D. Anderson Cancer CenterHouston, Texas