A Phase 1/2 Study to Evaluate CHM-2101, an Autologous Cadherin 17 Chimeric Antigen Receptor (CAR) T Cell Therapy

Summary

Objectives

This is a Phase 1/2 open-label study to evaluate CHM-2101, an autologous CDH17 CAR T-cell
therapy for the treatment of advanced gastrointestinal (GI) cancers that are relapsed or
refractory to at least 1 standard treatment regimen in the metastatic or locally advanced
setting.

The study has 2 parts: Phase 1, Dose Escalation and Expansion, and Phase 2. Potential
participants will provide written consent and be screened for study eligibility prior to
undergoing any screening procedures, including leukapheresis. Protocol-specified criteria
must be met prior to the start of leukapheresis for collection of peripheral blood
mononuclear cells (PBMCs). Eligible participants will undergo leukapheresis to collect
PBMCs for product manufacturing, which comprises enrichment of T cells, lentiviral
transduction, ex vivo expansion, and cryopreservation of the CHM-2101 cell product.
Participants who have a leukapheresis or manufacturing failure may be permitted a second
attempt at leukapheresis.

Bridging chemotherapy (treatment between the time of leukapheresis and first dose of
lymphodepleting chemotherapy [LDC]) is permitted at the discretion of the investigator,
if needed to maintain disease stability during CHM-2101 manufacturing time. Bridging
chemotherapy is prohibited within the 2 weeks prior to leukapheresis and 2 weeks prior to
planned CHM-2101 infusion. Specific criteria to proceed should be reviewed prior to
leukapheresis, LDC, and CHM-2101 infusion. Participants will be followed in this study
for 18 months or until disease progression.