Dose Escalation and Expansion Study of TROP2 CAR Engineered IL-15- Transduced Cord Blood-derived NK Cells in Combination With Cetuximab in Patient With Colorectal Cancer (CRC) With Minimal Residual Disease (MRD)

Description

Primary Objective:

1. To determine the safety, tolerability, maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of TROP2-CAR-NK cells combined with cetuximab in patients with MRD CRC.
2. To evaluate circulating tumor DNA (ctDNA) clearance (undetectable) at 3 months

Secondary Objectives:

1. Determine progression-free survival.
2. To quantify the persistence of infused allogeneic donor TROP2-CAR-NK cells in the peripheral blood of the recipient.
3. To evaluate blood- and tissue-based biomarkers at baseline associated with response and resistance to TROP2-CAR-NK cell infusion in combination with cetuximab.

Exploratory Objectives:

1. To profile and assess dynamic immune changes in the tumor microenvironment.
2. Quantify the average circulating ctDNA change from TROP2-CAR-NK infusion to progression or initiation of a new cancer therapy and association with PFS.
3. To evaluate patient-reported quality of life (QoL).