Spots Global Cancer Trial Database for 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)

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Trial Identification

Brief Title: 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)

Official Title: Phase 1 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)

Study ID: NCT06358430

Conditions

Colorectal Cancer

Minimal Residual Disease

Interventions

Fludarabine Phosphate

Lymphodepleting Chemotherapy

Study Description

Brief Summary: To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.

Detailed Description: Primary Objective: 1. To determine the safety, tolerability, optimal cell dose (OCD), maximum tolerated dose (MTD), and recommended Phase 2 dose (RP2D) of TROP2-CAR-NK cells combined with cetuximab in participants 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).