Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors
Recruiting · NCT04842812 · Interventional (participants receive a specific treatment) · Lead sponsor: Second Affiliated Hospital of Guangzhou Medical University
View the official record on ClinicalTrials.gov →Interventions studied
TILs and CAR-TILs targeting HER2, Mesothelin, PSCA, MUC1, Lewis-Y, GPC3, AXL, EGFR, Claudin18.2/6, ROR1, GD1, or B7-H3
What this trial is about
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 take part
Age range
18 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 1
Study type
Interventional (participants receive a specific treatment)
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.
Where it is running
2 locations listed.
- Second Affiliated Hospital of Guangzhou Medical University - Guangzhou, China
- Second Affiliated Hospital of Guangzhou Medical University - Guangzhou, China