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TROP2-CAR-NK Cells with Cetuximab

Active, not recruitingPhase 1InterventionalNCT06358430 ↗

This is a study designed to evaluate varying doses of TROP2-CAR-NK cells combined with cetuximab and their ability to clear ctDNA in patients with minimal residual colorectal cancer.

Sponsor
M.D. Anderson Cancer Center
Planned enrollment
10 participants
Start date
December 2, 2024
Primary completion
January 18, 2029 (est.)
Minimum age
18 Years
Interventions
Fludarabine Phosphate, Cyclophosphamide, Cetuximab, TROP2-CAR-NK Cells, Rimiducid (AP1903), Lymphodepleting Chemotherapy

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)

This study Phase I study designed to find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.  Chimeric antigen receptors (CAR) attached to natural killer (NK) cells enhance your body’s natural ability to find and attack cancer cells.

Primary Objectives:

  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. To 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

Key Eligibility Criteria

  • Patients with documented CRC with MRD following complete resection and standard-of-care adjuvant treatment
  • Patients must have an Eastern Cooperative Oncology Group (ECOG) performance status of 0 or 1
  • Patients must be willing to stay within a 100-mile radius of the study site during the first 4 weeks after the TROP2-NK cell infusion

Drug: Fludarabine Phosphate

Drug: Cyclophosphamide

Drug: Cetuximab

Drug: TROP2-CAR-NK Cells

Drug: Rimiducid (AP1903)

Procedure: Lymphodepleting Chemotherapy

See ClinicalTrials.gov for more details:

Study Record

Where this trial is offered

  • MD Anderson Cancer CenterHouston, Texas

Status, sites, and study facts from ClinicalTrials.gov, last posted August 4, 2026 and refreshed here September 5, 2026.View the full record for NCT06358430.