RecruitingPhase 1NCT04842812

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

Engineered TILs/CAR-TILs With PD1 Knockout and Anti-PD1/CTLA4-scFv Secreting or CARs Against Various Antigens to Treat Advanced Solid Tumors


Sponsor

Second Affiliated Hospital of Guangzhou Medical University

Enrollment

40 participants

Start Date

Jan 1, 2021

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 85 Years

Inclusion Criteria5

  • 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 Criteria7

  • 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.

Interventions

BIOLOGICALTILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3

TILs and CAR-TILs injection: 1-10×10e7/kg cells for each treatment; 3 or more cycles.


Locations(1)

Second Affiliated Hospital of Guangzhou Medical University

Guangzhou, China

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NCT04842812


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