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.
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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
80
M D Anderson Cancer Center
Houston, Texas, United States
RECRUITINGNumber of Participants With Treatment-Related Adverse Events as Assessed by CTCAE Version 5.0.
CTCAE Version 5.0 - General grading: Grade 1: Mild: discomfort present with no disruption of daily activity, no treatment required beyond prophylaxis. Grade 2: Moderate: discomfort present with some disruption of daily activity, require treatment. Grade 3: Severe: discomfort that interrupts normal daily activity, not responding to first line treatment. Grade 4: Life Threatening: discomfort that represents immediate risk of death
Time frame: through study completion, an average of 1 year
Number of Participants with Complete or Partial Response
Time frame: Up to 30 days after the last treatment
Number of Participants who are Alive and in Remission
Number of Participants who are Alive and in Remission after 6 months.
Time frame: Up to 180 days
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