Phase I/II Study of CAR.70- Engineered IL15-transduced Cord Blood-derived NK Cells in Conjunction With Lymphodepleting Chemotherapy for the Management of Relapse/Refractory Hematological Malignances
M.D. Anderson Cancer Center
Summary
The goal of this clinical research study is to learn about the safety of giving immune cells called natural killer (NK) cells with chemotherapy to patients with leukemia, lymphoma, or multiple myeloma. Immune system cells (such as NK cells) are made by the body to attack foreign or cancerous cells. Researchers think that NK cells you receive from a donor may react against cancer cells in your body, which may help to control the disease.
Description
Primary Objective: To determine the safety, efficacy and optimal cell dose of CAR.70/IL15-transduced CB-NK cells in patients with relapsed/refractory hematological malignances. The efficacy and optimal dose will be identified for individual diseases. Secondary Objectives: * To quantify persistence of infused allogeneic donor CAR-transduced CB-derived NK cells in the recipient. * To conduct comprehensive immune reconstitution studies.
Eligibility
- Age range
- 12–80 years
- Sex
- All
- Healthy volunteers
- No
Inclusion criteria: 1. Patients with hematological malignances with an expression of CD70 in the pre-enrollment tumor sample ≥ 10% measured by immunohistochemistry or flow cytometry. 2. Patients must meet diseases specific eligibility criteria (see below) 3. Patients at least 1 week from last cytotoxic chemotherapy at the time of starting lymphodepleting chemotherapy, except for Hydroxyurea which is allowed for peripheral blood count control in AML, CML, and MDS patients until the day prior to administration of lymphodepleting chemotherapy. Patients may continue tyrosine kinase inhibitors or…
Interventions
- DrugCyclophosphamide
Given by IV
- DrugCAR.70/IL15-transduced CB-NK cells
Given by IV
- DrugFludarabine phosphate
Given by IV
Location
- M D Anderson Cancer CenterHouston, Texas