The Safety and Efficacy of CART-19 Cells in B-cell Acute Lymphoblastic Leukemia (B-ALL).
- Conditions
- B-cell Acute Lymphoblastic Leukemia
- Interventions
- Registration Number
- NCT02924753
- Lead Sponsor
- Henan Cancer Hospital
- Brief Summary
This is a study for patients who have been previously treated for B-ALL. The purpose of this study is to determine the safety and feasibility of CART-19 cells to the patients with relapsed and refractory CD19+ B-ALL.
- Detailed Description
Subjects will be staged and the suitability of their T cells for CART-19 manufacturing will be determined at entry phase,. Subjects will be collected large numbers of peripheral blood mononuclear cells (PBMC) for CART-19 manufacturing. The T cells will be purified from the PBMC, transduced with CART-19 lentiviral vector, expanded in vitro and then administered to subjects.
Subjects will have blood tests to assess safety and efficacy, and persistence of the CART-19 cells at regular intervals through four weeks after their last infusion of the study. Following the 6 months of intensive follow-up, subjects will be evaluated quarterly for two years with a physical examination, blood tests, bone marrow aspirate, minimal residual disease (MRD) and persistence of CART-19. Following this evaluation, subjects will be evaluated health problems every year for an additional thirteen years.
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 20
- 4 years to 70 years, expected survival > 3 months
- CD19 positive B-cell acute lymphoblastic leukemia
- Karnofsky Performance Status (KPS) >70
- Relapsed after allogeneic or autologous stem cell transplantation (SCT);
- Cardiac function: 1-2 levels; Liver: TBIL≤3 Upper Limit of Normal (ULN)，aspartate aminotransferase (AST) ≤2.5 ULN，ALT ≤2.5 ULN; kidney: Cr≤1.25 ULN; bone marrow: White Blood Cell (WBC) ≥ 3.0×109/L, Hb ≥90 g/L, Platelet (PLT) ≥ 80×109/L）
- No serious allergic constitution
- No other serous diseases that conflicts with the clinical program
- No other cancer history
- No serious mental disorder
- Informed consent is signed by a subject or his lineal relation.
- Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test)
- Uncontrolled active infection, HIV infection, syphilis serology reaction positive
- Active hepatitis B or hepatitis C infection
- Recent or current use of glucocorticoid or other immunosuppressor
- With severe cardiac, liver, renal insufficiency, diabetes and other diseases
- Transaminase >2.5 ULN, Bilirubin >3 ULN，Creatinine>1.25 ULN
- Participate in other clinical research in the past three months; previously treatment with any gene therapy products
- 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 CART-19 CART-19 cells patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2. CART-19 Cyclophosphamide patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2. CART-19 Fludarabine patients will receive a pre-conditioning with cyclophosphamide and fludarabine before infusion of CART-19 cells. The CART-19 cells are to be administered on day0,day1,day2.
- Primary Outcome Measures
Name Time Method safety as assessed by the occurrence of study related adverse events. 6 months monitor the occurrence of study related adverse events.
- Secondary Outcome Measures
Name Time Method duration of CART-19 2 years Determine duration of in vivo survival of CART-19 cells.
efficacy 2 years anti-tumor activity of CART-19 cells will be determined in a follow-on study
Trial Locations
- Locations (1)
Henan Cancer Hospital
🇨🇳Zhengzhou, Henan, China