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OncoMatch/Clinical Trials/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)

Is NCT06358430 recruiting? Yes, currently enrolling (May 2026). This Phase 1 trial studies multiple treatments for colorectal cancer.

Phase 1RecruitingM.D. Anderson Cancer CenterNCT06358430Data as of May 2026

Treatment: Fludarabine Phosphate · Cyclophosphamide · Cetuximab · TROP2-CAR-NK Cells · Rimiducid (AP1903)To find the highest and/or recommended dose of TROP2-CAR-NK cells combined with cetuximab in participants with MRD CRC.

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Extracted eligibility criteria

Cancer type

Colorectal Cancer

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Must have received: adjuvant therapy — post-resection

complete disease resection followed by standard-of-care adjuvant treatment

Cannot have received: systemic anticancer therapy

Exception: allowed if >2 weeks or 3 half-lives prior to lymphodepleting chemotherapy; monoclonal antibodies require >3 weeks

Has received systemic anticancer therapy within 2 weeks or 3 half-lives, whichever is shorter, prior to the start of lymphodepleting chemotherapy. For patients treated with monoclonal antibodies, at least 3 weeks must have elapsed prior to the start of lymphodepleting chemotherapy.

Cannot have received: radiation therapy

Exception: allowed if >2 weeks prior to lymphodepleting chemotherapy and recovered from all radiation-related toxicities

Has received prior radiotherapy within 2 weeks of the start of lymphodepleting chemotherapy. Participants must have recovered from all radiation-related toxicities, not require corticosteroids, and not have had radiation pneumonitis or colitis.

Cannot have received: genetically modified T or NK cell therapy

Prior genetically modified T or NK cell therapy

Cannot have received: live vaccine

Exception: allowed if >6 weeks prior to TROP2-CAR-NK infusion and not within 24 months post infusion

Has received a live vaccine within 6 weeks prior to TROP2-CAR-NK infusion and for at least 24 months post infusion

Lab requirements

Blood counts

ANC ≥1500/μL; Platelets ≥100,000/μL; Hemoglobin ≥9.0 g/dL

Kidney function

CrCl by Cockcroft-Gault formula ≥45 mL/min for patients with creatinine >1.5 x ULN

Liver function

Total bilirubin ≤1.5 x ULN OR direct bilirubin ≤ULN for patients with total bilirubin levels >1.5 x ULN; AST and ALT ≤2.5 x ULN (≤5 x ULN for patients with history of resected liver metastases)

Cardiac function

Left ventricular ejection fraction >50%. Prolongation of corrected QT interval using Fridericia's formula to >480 milliseconds, unless cleared after cardiology evaluation.

Participants must have adequate organ function as defined below (Table 1)... Left ventricular ejection fraction >50%. Prolongation of corrected QT interval using Fridericia's formula to >480 milliseconds, unless cleared after cardiology evaluation.

Structured fields extracted by AI. May contain errors — verify against the official protocol.

US trial sites

  • MD Anderson Cancer Center · Houston, Texas

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