RecruitingPhase 1

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

China40 participantsStarted 2021-01-01

Plain-language summary

Tumor infiltration lymphocytes (TILs) have been harvested from advanced cancer patients and constructed to knockout PD1 gene and express scFvs against both PD1 and CTALA4 and CARs against various antigens, followed by transfusion into the patients. The safety, tolerance, and preliminary clinical efficacy of the TILs will be evaluated.

Who can participate

Age range18 Years – 85 Years

SexALL

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Inclusion criteria

✓. Patients with advanced cancers that failed to current available therapies;
✓. Life expectancy \>12 weeks;
✓. Adequate heart, lung, liver, kidney functions;
✓. Available for tumor biopsy or cancerous effusions;
✓. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent.

Exclusion criteria

✕. Had accepted gene therapy before;
✕. Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity;
✕. Active infectious disease related to bacteria, virus, fungi, et al;
✕. Other severe diseases that the investigators consider not appropriate;
✕. Pregnant or lactating women;
✕. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day);
✕. Other conditions that the investigators consider not appropriate.

What they're measuring

Safety of TILs/CAR-TILs treatment in advanced solid cancers

Timeframe: up to 36 months

Trial details

NCT IDNCT04842812

SponsorSecond Affiliated Hospital of Guangzhou Medical University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2029-12-31

Contact for this trial

Zhenfeng Zhang, MD, PhD

+862039195966 zhangzhf@gzhmu.edu.cn

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