High Efficient Killing Cell Therapy for advanced lung cancer
Phase I Study of High Efficient Killing Cell Therapy for Advanced Non Small Cell Lung Cancer
PHASE1 · Ruijin Hospital · NCT03193567
This study is testing a new treatment called High Efficient Killing Cell Therapy to see if it can help people with advanced lung cancer who haven't had success with other therapies.
Quick facts
| Phase | PHASE1 |
|---|---|
| Study type | Interventional |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Ruijin Hospital (other) |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT03193567 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of High Efficient Killing Cell Therapy (HEKT) in patients with advanced non-small cell lung cancer (NSCLC) who have not responded to standard treatments. Participants must have pathologically confirmed NSCLC and have failed at least two lines of chemotherapy and one line of targeted therapy. The trial is exploratory and aims to gather preliminary data on the effectiveness of this novel therapy in a challenging patient population.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 70 with advanced NSCLC who have exhausted standard treatment options.
Not a fit: Patients with severe comorbidities, brain metastasis, or those currently undergoing immunosuppressive treatment may not benefit from this study.
Why it matters
Potential benefit: If successful, this therapy could provide a new treatment option for patients with refractory advanced NSCLC.
How similar studies have performed: While this approach is novel, similar therapies have shown promise in other cancer types, indicating potential for success.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female patients' age from 18 years to 70 years. * Patients who have a life expectancy of at least 3 months. * pathologically confirmed non-small cell lung cancer. * failed in previous standard chemotherapy and targeted therapy. * Karnofsky performance status 0-1. * adequate organ functions. Exclusion Criteria: * Pregnant and lactating women. * Patients with T cell lymphoma, syphilis, AIDS or combination * Patients with highly allergic or have a history of severe allergies * Patients with severe hepatic or renal dysfunction * Patients with severe autoimmune disease or who is being treated with immunosuppressive agents * Patients with severe infection not controlled or High fever * Patients with organ transplantation or waiting for organ transplantation. * Patients with brain metastasis * Patients with severe coagulopathy (e.g. hemophilia) * Patients without adequate ability to understand, sign informed consents and take part in the clinical research voluntarily.
Where this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (RECRUITING)
Study contacts
- Study coordinator: Lei H Du, M.S
- Email: sealing821201@hotmail.com
- Phone: 13918570392
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.
Conditions: Non Small Cell Lung Cancer