Status:
UNKNOWN
Antigen-specific T Cells Against Lung Cancer
Lead Sponsor:
Shenzhen Geno-Immune Medical Institute
Conditions:
Lung Cancer
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
PHASE2
Brief 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 immu...
Detailed Description
Lung cancer is a malignancy characterized by uncontrolled cell growth in tissues of the lung. There are two main types of lung cancer, small-cell lung carcinoma (SCLC) and non-small-cell lung carcinom...
Eligibility Criteria
Inclusion
- 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.
- 10\. Oxygen saturation ≥ 90%. 11. Written, informed consent obtained prior to any study-specific procedures.
Exclusion
- 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.
- 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.
Key Trial Info
Start Date :
December 15 2017
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2020
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT03356808
Start Date
December 15 2017
End Date
December 31 2020
Last Update
September 19 2019
Active Locations (3)
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1
Jinshazhou Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong, China, 510415
2
Shenzhen Geno-immune Medical Institute
Shenzhen, Guangdong, China, 518000
3
Yunnan Cancer Hospital & The Third Affiliated Hospital of Kunming Medical University & Yunnan Cancer Center
Kunming, Yunnan, China, 650000