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.
Patients with hematological malignances with an expression of CD5 in the pre-enrollment tumor sample ≥ 30% measured by immunohistochemistry or flow cytometry.
Patients must meet diseases specific eligibility criteria (see below)
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 chemotherapy, with the last day of tyrosine kinase inhibitors or other targeted therapies no later than Day-9.
Localized radiotherapy to one or more disease sites are allowed prior the infusion provided that there are additional disease sites that are not irradiated.
Positive beta HCG in female of child-bearing potential defined as not postmenopausal for 24 months or no previous surgical sterilization or lactating females.
Presence of clinically significant Grade 3 or greater toxicity from the previous treatment, as determined by PI.
Presence of uncontrolled fungal, bacterial, viral, or other infection not responding to appropriate therapy.
Active hepatitis B or C.
Sequential
Fludarabine Phosphate
DrugGiven by IV
Cyclophosphamide
DrugGiven by IV
CAR.5/IL15-transduced CB-NK cells
DrugGiven by IV
Number of Participants With Treatment-Related Adverse Events as Assessed by 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
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