NCT04842812 Engineered TILs/CAR-TILs to Treat Advanced Solid Tumors
| NCT ID | NCT04842812 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Liver Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 40 participants |
| Start Date | 2021-01-01 |
| Primary Completion | 2029-12-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 40 participants in total. It began in 2021-01-01 with a primary completion date of 2029-12-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
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.
Contact & Investigator
Zhenfeng Zhang, MD, PhD
PRINCIPAL INVESTIGATOR
Second Affiliated Hospital of Guangzhou Medical University
Frequently Asked Questions
Who can join the NCT04842812 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 85 Years, studying Liver Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT04842812 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT04842812 currently recruiting?
Yes, NCT04842812 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT04842812 trial being conducted?
This trial is being conducted at Guangzhou, China.
Who is sponsoring the NCT04842812 clinical trial?
NCT04842812 is sponsored by Second Affiliated Hospital of Guangzhou Medical University. The principal investigator is Zhenfeng Zhang, MD, PhD at Second Affiliated Hospital of Guangzhou Medical University. The trial plans to enroll 40 participants.
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