Non-hodgkin Lymphoma,B Cell
Conditions
Keywords
non-Hodgkin's lymphoma, CART
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.
Interventions
BIOLOGICALCART-19 and 20 cells
Double-target CART-19 and 20 cells will be administered on day0 after completion of the chemotherapy.
DRUGCyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 500mg/m2/day IV for 2 days(Day-3 to day-2).
DRUGFludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-4 to day-2).
Sponsors
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| objective response rate | 28 days and 3 months after recieving intravenous CART cells | the proportion of patients benefit from the therapy |
| 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 |
Countries
China
Contacts
Primary ContactZhihua Yao, M.D. Ph.D
Backup ContactYanyan Liu, M.D. Ph.D
Outcome results
None listed