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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 (Jun 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 Jun 2026Location: China

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

Treatments studied

Chemotherapy

CyclophosphamideFludarabine

Other

Mutant KRAS G12V-specific TCR transduced autologous T cellsAnti-PD-1 monoclonal antibody

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)

Demographics

Ages ≤ 75

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.

Frequently asked questions

Is NCT04146298 currently recruiting?

Yes, this trial is currently recruiting patients.

Is prior treatment required for enrollment?

Yes. Patients must have previously received standard chemotherapy and surgery and adjuvant chemotherapy.

Does this trial require KRAS?

Yes, KRAS G12V is a required biomarker for enrollment.

Does this trial require HRAS?

Yes, HRAS G12V is a required biomarker for enrollment.

Does this trial require NRAS?

Yes, NRAS G12V is a required biomarker for enrollment.

Is there an age limit?

Yes. Patients must be 75 years or younger.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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