Engineered TILs and CAR-TILs for treating advanced solid tumors

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial focuses on patients with advanced solid tumors, including liver, lung, breast, colorectal cancers, and brain tumors. Tumor-infiltrating lymphocytes (TILs) are harvested from these patients and genetically engineered using CRISPR-Cas9 to enhance their cancer-fighting capabilities by knocking out the PD1 gene and expressing specific CARs targeting various tumor antigens. The engineered TILs are then transfused back into the patients to evaluate their safety, tolerance, and preliminary clinical efficacy. The study aims to provide a novel approach to treating cancers that have not responded to existing therapies.

Why it matters

Who can join: the full rules

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.

Where it's running

• Second Affiliated Hospital of Guangzhou Medical University
  Guangzhou, China Recruiting

Study contacts

• Principal investigator: Zhenfeng Zhang, MD, PhD — Second Affiliated Hospital of Guangzhou Medical University
• Study coordinator: Zhenfeng Zhang, MD, PhD
• Email: zhangzhf@gzhmu.edu.cn
• Phone: +862039195966

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.