Phase I/II of Umbilical Cord Blood-Derived CAR-Engineered NK Cells in Conjunction with Lymphodepleting Chemotherapy in Patients with Relapsed/Refractory B-Lymphoid Malignancies
MD Anderson Study Status
Fludarabine, Cyclophosphamide, Mesna, iC9/CAR.19/IL15-Transduced CB-NK Cells, AP1903
If you are reading and signing this form on behalf of a potential participant, please note: Any time the words "you," "your," "I," or "me" appear, it is meant to apply to the potential participant. The goal of this clinical research study is to learn if giving genetically changed immune cells, called CAR-NK cells, after chemotherapy will improve the disease in stem cell transplant patients with relapsed (has returned) and/or refractory (has not responded to treatment) B-cell lymphoma or leukemia. Also, researchers want to find the highest tolerable dose of CAR-NK cells to give to patients with relapsed or refractory B-cell lymphoma or leukemia. The safety of this treatment will also be studied. This is an investigational study. The making of and infusion of genetically changed NK cells and the drug AP1903 (if you receive it, explained below) are not FDA approved or commercially available for use in this type of disease. They are currently being used for research purposes only. The chemotherapy drugs in this study (fludarabine, cyclophosphamide, and mesna) are commercially available and FDA approved. Up to 36 patients will take part in this study. All will be enrolled at MD Anderson.
Resources and Links
Phone Number: 1-877-MDA-6789
Information and next steps
B-Lymphoid Malignancies, Acute Lymphocytic Leukemia, Chronic Lymphocytic Leukemia, Non-hodgkin Lymphoma
Stem Cell Transplantation
For general questions about clinical trials:
Due to our response to COVID-19, all blood donations at MD Anderson
Blood Donor Center locations are being held by appointment only.