Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors

Launched by SECOND AFFILIATED HOSPITAL OF GUANGZHOU MEDICAL UNIVERSITY · Apr 9, 2021

Keywords

ClinConnect Summary

This clinical trial is investigating a new treatment for advanced solid tumors, including liver, lung, breast, colorectal cancers, and brain tumors. The study focuses on using specially engineered immune cells, called tumor-infiltrating lymphocytes (TILs), which are taken from patients’ own tumors. These cells are modified to improve their ability to fight cancer. The main goals of the trial are to find out if this treatment is safe and how well it works in patients whose current cancer therapies have not been successful.

To participate in this trial, patients must have advanced cancer that has not responded to other treatments and should expect to live for at least 12 more weeks. They need to be able to undergo a tumor biopsy and have good health in their heart, lungs, liver, and kidneys. However, some patients may not be eligible, such as those who have had gene therapy before or have certain severe infections or health conditions. If someone qualifies and chooses to participate, they will receive the engineered immune cells and be closely monitored for any side effects and the treatment's effectiveness.

Gender

ALL

Eligibility criteria

• 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.