Phase I/II Study of CD5 CAR Engineered IL15-Transduced Cord Blood-Derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapsed/Refractory Hematological Malignances
M.D. Anderson Cancer Center
Summary
To determine the safety, efficacy and optimal cell dose of CAR 5/IL15-transduced CB-NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases.
Description
Primary objective: To determine the safety, tolerability and optimal cell dose of iC9/CD5CAR/IL-15 NK cells in patients with relapsed/refractory T-cell malignances, mantle cell lymphoma, and chronic lymphocytic leukemia. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives: * To assess the overall response rate (complete and partial response rates) * To quantify persistence of infused allogeneic donor iC9/CD5CAR/IL-15 NK cells in the recipient. * To conduct comprehensive immune reconstitution studies.
Eligibility
- Age range
- 18+ years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria 1. Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry. 2. Patients must meet diseases specific eligibility criteria (see below) 3. Patients should be at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, with the last day of cytotoxic chemotherapy no later than Day-13. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemothe…
Interventions
- DrugFludarabine Phosphate
Given by IV
- DrugCyclophosphamide
Given by IV
- DrugCAR.5/IL15-transduced CB-NK cells
Given by IV
Location
- M D Anderson Cancer CenterHouston, Texas