A Safety and Efficacy Study of CD-19 t-haNK in Patients With B-cell Acute Lymphoblastic Leukemia

Up to 20 participants may be screened to enroll up to 10 patients who will receive at least 1 dose of study drug. The initial three participants will receive study drug in a staggered fashion, with a 7-day interval between each participant to evaluate the safety profile of the investigational product.

Patients will receive two 4-week cycles of IV CD19 t-haNK IV as a single agent regimen. Following a 1-week safety pause, patients will then receive 1 additional cycle of CD19 t-haNK given twice a week on an outpatient basis. Patients with no evidence of disease progression may be eligible to receive 2 additional cycles of treatment. Bone marrow aspirate will be performed for bone marrow analysis on day 22( +/- 3 days), and every 8 weeks( +/-1 week) thereafter. If there is no evidence of abnormal blasts present in bone marrow, measurable residual( MRD) testing will be performed. Treatment will be discontinued if a participant has confirmed progressive disease or unacceptable toxicity. Safety will be assessed for all participants.