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.
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;
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;
Single group
TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3
Biological/VaccineTILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.
Safety of TILs/CAR-TILs treatment in advanced solid cancers
Assessing Number of participants with treatment-related adverse events as assessed by CTCAE v4.0.
Primary clinical efficacy of the TILs/CAR-TILs treatment in advanced solid cancers
Assessing various clinical response rates including complete response, partial response, stable disease, and progress disease during and after TILs/CAR-TILs treatment in advanced solid cancers.
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Second Affiliated Hospital of Guangzhou Medical University
Lead sponsor
Guangdong Zhaotai InVivo Biomedicine Co. Ltd.
Collaborator
