Allogeneic NK T-Cells Expressing CD19 Specific CAR in B-Cell Malignancies

Active:	Yes
Cancer Type:	Leukemia	NCT ID:	NCT05487651
Trial Phases:	Phase I	Protocol IDs:	ATX-K502-001 (primary) NCI-2022-07299 ATX K502-001
Eligibility:	3 - 75 Years, Male and Female	Study Type:	Treatment
Study Sponsor:	Athenex, Inc.
NCI Full Details:	http://clinicaltrials.gov/show/NCT05487651

Summary

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).

Objectives

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.

Treatment Sites in Georgia

Winship Cancer Institute of Emory University
1365 Clifton Road NE
Building C
Atlanta, GA 30322
winshipcancer.emory.edu

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