To determine the safety and efficacy (1-year PFS) of iC9/CD5CAR/IL-15 NK cells as consolidation in patients with aggressive T-cell malignances in first remission.
18-80 years of age
Patients with hematological malignancies with an expression of CD5 in the tumor sample of ≥ 30% measured by immunohistochemistry or flow cytometry.
Patients must meet disease-specific eligibility criteria.
Patients should be at least 1 week 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.
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.
Single group
C9/CD5CAR/IL-15 NK cells
DrugGiven PO or IV
Rituximab
DrugGiven by IV
Fludarabine
DrugGiven by IV
Cyclophosphamide
DrugGiven by IV
Safety and Adverse Events (AEs)
Incidence of Adverse Events, Graded According to National Cancer Institute Common Terminology Criteria for Adverse Events (NCI CTCAE) Version (v) 5.0
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