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 weeks from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or other targeted therapies until at least three days prior to administration of lymphodepleting chemotherapy. 4. Localized radiotherapy to one or more disease sites are…
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