NCT06358430

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)

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)

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 42 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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, 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).

Conditions

• Colorectal Cancer
• Minimal Residual Disease

Interventions

Type	Name	Description
DRUG	Fludarabine Phosphate	Given by IV
DRUG	Cyclophosphamide	Given by IV
DRUG	Cetuximab	Given by IV
DRUG	TROP2-CAR-NK Cells	Given by IV
DRUG	Rimiducid (AP1903)	Given by IV
PROCEDURE	Lymphodepleting Chemotherapy	Given by Chemotherapy

Timeline

• Start date: 2024-12-02
• Primary completion: 2029-01-18
• Completion: 2029-01-18
• First posted: 2024-04-10
• Last updated: 2026-01-15

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study