Treatment using double-target CART-19 and 20 cells for Non-Hodgkin's Lymphoma
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Relapse and Refractory Patients With CD19+/CD20+ Non-Hodgkin's Lymphoma (NHL)
This study is testing a new treatment using special immune cells to see if it can help people with relapsed Non-Hodgkin's Lymphoma feel better after their previous treatments.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 20 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Henan Cancer Hospital Government |
| Drugs / interventions | CART |
| Locations | 1 site (Zhengzhou, Henan) |
| Trial ID | NCT06160362 on ClinicalTrials.gov |
What this trial studies
This study evaluates the safety and efficacy of double-target CART-19 and 20 cells in patients with relapsed and refractory Non-Hodgkin's Lymphoma (NHL) who have previously undergone treatment. Participants will receive CART-19 and 20 cells along with Cyclophosphamide and Fludarabine. The study aims to determine the feasibility of this approach in targeting CD19 and CD20 positive NHL. Patients will be monitored for safety and treatment outcomes throughout the study.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 with relapsed or refractory CD19+/CD20+ Non-Hodgkin's Lymphoma.
Not a fit: Patients with active malignancies requiring concurrent treatment or severe comorbidities may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat Non-Hodgkin's Lymphoma.
How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results, indicating potential success for this novel approach.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Age between 18 to 75 years old (including 18 and 75) 2. Diagnosed as R/R NHL 3. CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry 4. Having at least one measurable lesions 5. World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2 6. Life expectancy no less than 3 months 7. enough main organ function 8. Pregnancy test within 7 days must be negative for women of childbearing period, and appropriate measures should be taken for contraception for women in childbearing period during the study and 12 months after this study 9. Agreeing to sign the written informed consents Exclusion Criteria: 1. Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months 2. Active GVHD 3. History of severe pulmonary dysfunction 4. Active malignant tumor need be treated at the same time 5. Uncontrolled active acute/chronic infection 6. Severe autoimmune diseases or congenital immunodeficiency 7. Untreated active hepatitis 8. HIV-positive, AIDS patients and syphilis infection 9. History of severe allergies to biological products 10. Patients with a history of mental illness 11. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 12. Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
Where this trial is running
Zhengzhou, Henan
- Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university — Zhengzhou, Henan, China (Recruiting)
Study contacts
- Study coordinator: Zhihua Yao, M.D. Ph.D
- Email: zlyyyaozhihua1260@zzu.edu.cn
- Phone: +8613592622292
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.