Lung cancer-specific T cells: 1 infusion, for 1x10\^6\~1x10\^7 cells/kg via IV
Study 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
Sex
ALL
Min age
18 Years
Max age
80 Years
Healthy volunteers
No
Inclusion Criteria:
1. Patients with stage III, IV or relapsed lung cancer confirmed by histology and biopsy.
2. Age: ≥ 18 years and ≤ 80 years.
3. 4 weeks at least since last chemotherapy or radiotherapy and 2 weeks at least since last systemic steroid hormone and other immunosuppressive therapy.
4. Side Effects of Chemotherapy have subsided.
5. Cancer specific antigens are identified and shown to express at high levels (\>2+) in malignant tissues by immuno-histochemical staining or flow cytometry.
6. Karnofsky/Lansky ≥ 50%.
7. 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.
10\. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion Criteria:
1. Airway obstruction caused by tumor.
2. History of epilepsy or other central nervous system diseases.
3. Patients who require systemic corticosteroid or other immunosuppressive therapy.
4. History of prolonged or serious heart disease during QT.
5. history of serious cyclophosphamide toxicity.
6. 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.
8\. 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.
11\. Patients, in the opinion of investigators, may not be eligible or not able to comply with the study.
Primary outcome measure(s)
Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events — 3 months Physiological parameter (measuring cytokine response)
Trial sites (1)
Facility
City
Region
Status
Shenzhen Geno-immune Medical Institute
Shenzhen
Guangdong
More Shenzhen Geno-Immune Medical Institute trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
We use cookies to analyse site traffic and improve your experience. With your consent, we may also use cookies for advertising. You can change your choice at any time.