New immunotherapy using T-like NK cells for cancer without MHC-I
Induced-T Cell Like NK Cellular Immunotherapy for Cancers That Are Lack of MHC-I Expression
This study is testing a new cancer treatment that uses modified immune cells to help patients with advanced cancers that don't have certain markers for existing therapies.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Second Affiliated Hospital of Guangzhou Medical University Academic / other |
| Drugs / interventions | prednisone, CAR-T |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT03882840 on ClinicalTrials.gov |
What this trial studies
This clinical trial aims to develop a novel immunotherapy using T cell-like NK cells (ITNK) to treat advanced cancers that lack MHC-I molecule expression. The approach involves collecting patients' T cells, modifying them to enhance their cancer-fighting capabilities, and infusing these engineered cells back into the patients. The study is designed to evaluate the safety and efficacy of this therapy in a Phase 1 and Phase 2 setting, following successful pre-clinical investigations. The goal is to provide a new treatment option for patients with limited therapeutic targets.
Who should consider this trial
Good fit: Ideal candidates include patients with advanced cancer expressing low or no MHC-I and who have adequate organ function.
Not a fit: Patients with a history of gene therapy, severe viral infections, or other significant health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could offer a new treatment avenue for patients with advanced cancers that currently have no effective options.
How similar studies have performed: While this approach is innovative, it builds on existing concepts of immunotherapy, and similar studies have shown promise in enhancing cancer treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Patients with advanced cancer, which express low or no MHC-I. 2. Life expectancy \>12 weeks 3. Adequate heart,lung,liver,kidney function 4. Available autologous T cells 5. Informed consent explained to, understood by and signed by patient/guardian. 6. 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 3. Known HIV positivity 4. History of liver or other organ transplantation 5. Active infectious disease related to bacteria, virus,fungi,et al 6. Other severe diseases that the investigators consider not appropriate; 7. Pregnant or lactating women 8. Systemic steroid treatment (greater than or equal to 0.5 mg prednisone equivalent/kg/day) 9. Other conditions that the investigators consider not appropriate.
Where this trial is running
Guangzhou, Guangdong
- The Second Affiliated Hospital of Guangzhou Medical University — Guangzhou, Guangdong, 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: +862034153532
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.