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OncoMatch/Clinical Trials/NCT05060796

Study of CXCR5 Modified EGFR Targeted CAR-T Cells for Advanced NSCLC

Is NCT05060796 recruiting? Yes, currently enrolling (May 2026). This Early Phase 1 trial studies CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cells for non small cell lung cancer.

Early Phase 1RecruitingSecond Affiliated Hospital of Guangzhou Medical UniversityNCT05060796Data as of May 2026

Treatment: CXCR5 modified EGFR Chimeric Antigen Receptor Autologous T cellsThis study is a single arm, open-label, intravenous infusion of Anti- Epidermal growth factor receptor (EGFR) Chimeric Antigen Receptor (CAR) T cells modified by C-X-C Chemokine receptor type 5 (CXCR 5) in patients with advanced adult non-small cell lung cancer (NSCLC).

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Extracted eligibility criteria

Cancer type

Small Cell Lung Cancer

Biomarker criteria

Required: EGFR expression (IHC score 2+ or more)

the immuno- histochemical test must determine that the expression of EGFR in the tumor site of the patient reaches the positive standard and the score is 2 + or more

Required: CXCL13 expression (positive rate ≥ 10%)

Pathological results suggest that CXCL13 factor positive rate ≥ 10 %

Disease stage

Metastatic disease required

advanced non-small cell lung cancer(Including TKI treatment failure patients); ... The patient has at least one tumor lesion that can be measured (Results available within one month prior to screening period)

Performance status

ECOG 0–1(Restricted strenuous activity)

Prior therapy

Cannot have received: gene therapy

Patients who have previously received any gene therapy product treatment, including CAR-T treatment

Cannot have received: antitumor chemotherapy (other than lymphocyte clearance chemotherapy)

Exception: within 14 days before the EGFR CAR-T infusion

Patients who had undergone antitumor chemotherapy other than lymphocyte clearance chemotherapy within 14 days before the EGFR CAR-T infusion

Cannot have received: other research drugs

Exception: within 30 days before infusion

Screening of patients who had received other research drugs within 30 days before infusion

Cannot have received: radiotherapy

Exception: within 2 weeks before infusion

Patients undergoing radiotherapy ... within 2 weeks before infusion

Cannot have received: TKI treatment

Exception: within 2 weeks before infusion

Patients undergoing ... TKI treatment within 2 weeks before infusion

Lab requirements

Blood counts

White blood cells ≥ 2 × 10^9/L; Platelet ≥ 100 x 10^9/L; Hemoglobin ≥ 100 g/L (subjects can meet this requirement through blood transfusion)

Kidney function

Serum creatinine ≤ 1.6 mg/ml or the creatinine clearance ≥ 40 ml/min/1.73m

Liver function

Total bilirubin < 1.5 times upper limits of normal

Cardiac function

Hemodynamics determined by echocardiography or MUGA are stable and LVEF ≥ 50%

Patients must have evidence of adequate hepatic and renal function ... sufficient bone marrow reserves ... hemodynamics determined by echocardiography or multichannel radionuclide angiography(MUGA) are stable and the left ventricular ejection fraction (LVEF)≥50%

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

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