Status:
UNKNOWN
The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
Lead Sponsor:
Henan Cancer Hospital
Conditions:
Non-hodgkin Lymphoma,B Cell
Eligibility:
All Genders
18-75 years
Phase:
NA
Brief Summary
This is a study for patients who have been previously treated for NHL. The purpose of this study is to determine the safety and feasibility of double-target CART-19 and 20 cells to the patients with r...
Eligibility Criteria
Inclusion
- Age between 18 to 75 years old (including 18 and 75)
- Diagnosed as R/R NHL
- CD19/CD20 positive confirmed by cell flow cytometry or immunohistochemistry
- Having at least one measurable lesions
- World health organization-Eastern Cooperative Oncology Group Performance Status (ECOG) 0-2
- Life expectancy no less than 3 months
- enough main organ function
- 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
- Agreeing to sign the written informed consents
Exclusion
- Congestive heart failure, uncontrolled coronary heart disease, arrhythmia and heart infarction less than 12 months
- Active GVHD
- History of severe pulmonary dysfunction
- Active malignant tumor need be treated at the same time
- Uncontrolled active acute/chronic infection
- Severe autoimmune diseases or congenital immunodeficiency
- Untreated active hepatitis
- HIV-positive, AIDS patients and syphilis infection
- History of severe allergies to biological products
- Patients with a history of mental illness
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
- Researchers think of that does not fit to participate in the study, or other cases that affect the clinical trial results
Key Trial Info
Start Date :
October 31 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06160362
Start Date
October 31 2023
End Date
December 1 2025
Last Update
December 7 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
Zhengzhou, Henan, China