Engineered TILs and CAR-TILs for treating 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
This study is testing a new way to treat advanced solid tumors by using specially modified immune cells from patients to see if they can better fight the cancer.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 85 Years |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone |
| Locations | 1 site (Guangzhou) |
| Trial ID | NCT04842812 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are patients with advanced cancers who have not responded to existing treatments and have a life expectancy of more than 12 weeks.
Not a fit: Patients with severe viral infections, those who have previously undergone gene therapy, or those with other severe health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could offer a new, effective treatment option for patients with advanced solid tumors that have failed current therapies.
How similar studies have performed: While the use of engineered TILs and CAR-TILs is a novel approach, similar studies have shown promise in treating various cancers, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Guangzhou
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.