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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Henan Cancer Hospital
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- safety as assessed by the occurrence of study related adverse events
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to 75 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
double-target CART-19 and 20
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.
Intervention: CART-19 and 20 cells (Biological)
double-target CART-19 and 20
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.
Intervention: Cyclophosphamide (Drug)
double-target CART-19 and 20
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.
Intervention: Fludarabine (Drug)
Outcomes
Primary Outcomes
safety as assessed by the occurrence of study related adverse events
Time Frame: from the date of recieving intravenous CART cells up to one month
monitor the occurrence of study related adverse events
Secondary Outcomes
- peripheral blood CART cell copy number(from the date of recieving intravenous CART cells up to one month)
- objective response rate(28 days and 3 months after recieving intravenous CART cells)
Investigators
Zhihua Yao, PhD
Director
Henan Cancer Hospital