UnknownPhase 1/2

Antigen-specific T Cells Against Lung Cancer

China20 participantsStarted 2017-12-15

Plain-language 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.

Who can participate

Age range18 Years – 80 Years

SexALL

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Inclusion criteria

✓. 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.

Exclusion criteria

✕. 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.

What they're measuring

Safety of engineered T cells in patients using CTCAE version 4.0 standard to evaluate the level of adverse events

Timeframe: 3 months

Trial details

NCT IDNCT03356808

SponsorShenzhen Geno-Immune Medical Institute

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-01-01

Contact for this trial

Lung-Ji Chang, PhD

86-075586725195 c@szgimi.org

View on ClinicalTrials.gov More Lung Cancer trials