Recruiting

Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

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.

ClinicalTrials.gov IDNCT04842812

PhasePHASE1

Enrollment40

SponsorSecond Affiliated Hospital of Guangzhou Medical University

Age18 Years

SexALL

I'm interested View official listing

Conditions studied

Liver Cancer, Lung Cancer, Breast Cancer, Colo-rectal Cancer, Brain Tumor, Solid Tumor, Adult, PD1, CTLA4

About this study

Interventions

Biological: TILs 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.

Primary outcomes

Safety of TILs/CAR-TILs treatment in advanced solid cancers (up to 36 months)

Eligibility information

Inclusion Criteria: 1. Patients with advanced cancers that failed to current available therapies; 2. Life expectancy \>12 weeks; 3. Adequate heart, lung, liver, kidney functions; 4. Available for tumor biopsy or cancerous effusions; 5. Informed consent explained to, understood by and signed by patient/guardian. Patient/guardian given copy of informed consent. Exclusion Criteria: 1. Had accepted gene therapy before; 2. Severe virus infection such as HBV, HCV, HIV, et al; Known HIV positivity; 3. Active infectious disease related to bacteria, virus, fungi, et al; 4. Other severe diseases that the investigators consider not appropriate; 5. Pregnant or lactating women; 6. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day); 7. Other conditions that the investigators consider not appropriate.

Study locations

Second Affiliated Hospital of Guangzhou Medical University, Guangzhou, 510260 China

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-27.