This study is a multi-center study to evaluate the safety of KUR-502 in subjects with refractory/relapsed B-cell NHL or leukemia (ALL or CLL).
KUR-502 will be manufactured from leukapheresis products from healthy donors. Subjects will be enrolled into 2 parallel cohorts (Cohort A [non-ALL] and Cohort B [ALL]). Each cohort will undergo dose escalation independently.
Three (3) dose levels will be evaluated in the ANCHOR and ANCHOR2 studies combined (1×107/m2, 3×107/m2, 1×108/m2). Dose levels are defined based on the number of transduced KUR-502 cells. Body surface area (BSA) will be capped at 2.4 m2. Subjects will receive <1×104 allogeneic T cells/kg at any dose level.
The MTD will be determined once dose escalation is completed, and all subjects are evaluable for DLT. If there is no DLT that determines an MTD, a maximum dose level will be declared. Dose escalation will stop when 6 subjects have been treated at the MTD or highest dose level.
Sponsor
Athenex, Inc.
Status of enrollment
Accepting new patients
Ages Eligible for Study
Adults aged 18 and up
Genders Eligible for Study
Female and Male
Disease indication
Non-Hodgkin Lymphoma, Lymphoma, Leukemia Diffuse Large B-Cell Lymphoma, Acute Lymphoblastic Leukemia, Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma
Principal Investigator
Charalambos Andreadis, MD
Contact
Caleb Hwang
Additional study eligibility details can be found at UCSF Clinical Trials.