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OncoMatch/Clinical Trials/NCT04146298

Mutant KRAS G12V-specific TCR Transduced T Cell Therapy for Advanced Pancreatic Cancer

Is NCT04146298 recruiting? Yes, currently enrolling (May 2026). This Phase 1/2 trial studies multiple treatments including Mutant KRAS G12V-specific TCR transduced autologous T cells and Cyclophosphamide for pancreatic cancer.

Phase 1/2RecruitingChanghai HospitalNCT04146298Data as of May 2026

Treatment: Cyclophosphamide · Fludarabine · Mutant KRAS G12V-specific TCR transduced autologous T cells · Anti-PD-1 monoclonal antibodyThis clinical trial will evaluate the safety and activity of mutant KRAS G12V-specific TCR transduced T cell therapy for advanced pancreatic cancer patients who express the KRAS G12V mutation and HLA-A\*11:01 allele. The theoretical basis of this study is that mutant KRAS antigen-specific TCR transduced autologous Tcells will target and kill HLA-matched mutant KRAS cancer cells but not normal cells.

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Extracted eligibility criteria

Cancer type

Pancreatic Cancer

Tumor Agnostic

Biomarker criteria

Required: KRAS G12V

Patient's tumor must express the KRAS G12V mutation

Required: HRAS G12V

or a G12V mutation in HRAS ... as determined by DNA or RNA sequencing methods

Required: NRAS G12V

or a G12V mutation in ... NRAS, as determined by DNA or RNA sequencing methods

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Min 1 prior line

Must have received: standard chemotherapy

who have received standard chemotherapy

Must have received: surgery and adjuvant chemotherapy

who have received surgery and adjuvant chemotherapy previously

Lab requirements

Blood counts

absolute neutrophil count >= 1000/mm^3; white blood cell count >= 3000/mm^3; platelet count >= 100,000/mm^3; hemoglobin > 8.0 g/dl

Kidney function

serum creatinine <= 1.6 mg/dl

Liver function

serum alt/ast <= 3.0 x uln; total bilirubin <= 1.5 mg/dl (<= 3.0 mg/dl if gilbert's syndrome)

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

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