RecruitingPhase 1Phase 2NCT03356808

Antigen-specific T Cells Against Lung Cancer

Multicenter Trial of Cancer Antigen-specific T Cells in the Treatment of Lung Cancer

Sponsor

Shenzhen Geno-Immune Medical Institute

Enrollment

20 participants

Start Date

Jun 1, 2026

Study Type

INTERVENTIONAL

Conditions

Lung Cancer

Summary

The purpose of this clinical trial is to assess the feasibility, safety and efficacy of cancer antigen-specific T cells targeting lung cancer. The cancer targeting antigens are identified through immunostaining of patient's cancer specimens. Another goal of the study is to learn more about the persistence and function of the ex vivo manipulated antigen-specific T cells in the body.

Eligibility

Min Age: 18 YearsMax Age: 80 Years

Inclusion Criteria15

Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
Age: ≥ 18 years and ≤ 80 years.
4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
Side Effects of Chemotherapy have subsided.
Cancer specific antigens are identified and shown to express at high levels (>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
Karnofsky/Lansky ≥ 50%.
Expected survival ≥ 6 weeks.
Initial hematopoietic conditions with
neutrophils (ANC) ≥ 1×10\^6/L;
platelet (PLT) ≥ 1×10\^8/L.
Proper renal and hepatic functions (ULN denotes "upper limit of normal range") with
serum creatinine ≤ 2×ULN;
serum bilirubin ≤ 3×ULN;
AST/ALT ≤ 5×ULN.
\. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.

Exclusion Criteria12

Airway obstruction caused by tumor.
History of epilepsy or other central nervous system diseases.
Patients who require systemic corticosteroid or other immunosuppressive therapy.
History of prolonged or serious heart disease during QT.
history of serious cyclophosphamide toxicity.
Current or recent treatment (within the 28-day period prior to Day 0) with another investigational drug or previous participation in any immune cell therapy study.
Inadequate liver and renal function with
serum creatinine > 2.5 mg/dl;
serum (total) bilirubin > 2.0 mg/dl;
AST \& ALT > 3 x ULN.
\. Pregnant or lactating females. 9. Serious active infection during screening. 10. Active HIV, Hepatitis B virus (HBV), Hepatitis C virus (HCV) infection or uncontrolled infection.
\. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.