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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)

Colorectal Cancer Clinical Trial

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)

Clinical Trial Summary

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

Clinical Trial 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). ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT06358430
Study type Interventional
Source M.D. Anderson Cancer Center
Contact Maria Pia Morelli, MD, PhD
Phone (713) 745-1297
Email mpmorelli@mdanderson.org
Status Not yet recruiting
Phase Phase 1
Start date October 31, 2024
Completion date January 18, 2029
View Details
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