NCT03778814 TCR-T Cell Immunotherapy of Lung Cancer and Other Solid Tumors
| NCT ID | NCT03778814 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University |
| Condition | Nonsmall Cell Lung Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 30 participants |
| Start Date | 2018-12-01 |
| Primary Completion | 2029-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
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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 30 participants in total. It began in 2018-12-01 with a primary completion date of 2029-12-30.
⚠ 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 organoids and TILs (and/or peripheral T cells) cultures will be established from fresh tissure of lung cancer and other solid tumors. Coculture will be utilized to screen tumor-responsive T cells which are further selected for monoclonal expansion and TCR cloning for engineered reconstitution of TCR-T cells. After verification by multiple in vitro and in vivo studies, a large number of TCR-T cells will be introduced back into the patients via vein, artery or fine needle punctured to the tumor, or combinations. In this phase I study, the safety, tolerance and preliminary efficacy of the TCR-T cell immunotherapy on human will firstly be assessed.
Eligibility Criteria
Inclusion Criteria: 1. patients with advanced lung tumor or other solid tumor where biopsy is obtainable 2. Life expectancy \>12 weeks 3. Child-Pugh-Turcotte score \<7 4. Adequate heart,lung,liver,kidney function 5. Available autologous transduced T cells with greater than or equal to 20% expression of targeted TCR sequences determined by flow-cytometry and killing of tumor cells greater than or equal to 20% in cytotoxicity assay 6. 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. Tumor size more than 25cm; 3. Severe virus infection such as HBV, HCV, HIV, et al 4. Known HIV positivity 5. History of lung transplantation 6. Active infectious disease related to bacteria, virus,fungi,et al 7. Other severe diseases that the investigators consider not appropriate; 8. Pregnant or lactating women 9. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 10. 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 NCT03778814 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Nonsmall Cell Lung 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 NCT03778814 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 NCT03778814 currently recruiting?
Yes, NCT03778814 is actively recruiting participants. Contact the research team at zhangzhf@gzhmu.edu.cn for enrollment information.
Where is the NCT03778814 trial being conducted?
This trial is being conducted at Guanzhou, China.
Who is sponsoring the NCT03778814 clinical trial?
NCT03778814 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 30 participants.
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