The Safety and Efficacy of Double-target CART-19 and 20 Cells in Non-Hodgkin's Lymphoma (NHL)
Not Applicable
Recruiting
- Conditions
- Non-hodgkin Lymphoma,B Cell
- Interventions
- Registration Number
- NCT06160362
- Lead Sponsor
- Henan Cancer Hospital
- 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 relapsed and refractory CD19+/CD20+ NHL.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 20
Inclusion Criteria
- 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 Criteria
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description double-target CART-19 and 20 Cyclophosphamide Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0. double-target CART-19 and 20 Fludarabine Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0. double-target CART-19 and 20 CART-19 and 20 cells Patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of double-target CART-19 and 20 cells. The double-target CART-19 and 20 cells are to be administered on day0.
- Primary Outcome Measures
Name Time Method safety as assessed by the occurrence of study related adverse events from the date of recieving intravenous CART cells up to one month monitor the occurrence of study related adverse events
- Secondary Outcome Measures
Name Time Method peripheral blood CART cell copy number from the date of recieving intravenous CART cells up to one month The highest concentration of CART cells in peripheral blood, the time to reach the highest concentration, and the area under the curve at 28 days after recieving intravenous CART cells
objective response rate 28 days and 3 months after recieving intravenous CART cells the proportion of patients benefit from the therapy
Trial Locations
- Locations (1)
Henan Cancer Hospital/The affiliated Cancer Hospital of ZhengZhou university
🇨🇳Zhengzhou, Henan, China