B-cell Acute Lymphoblastic Leukemia
Conditions
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.
Interventions
DRUGCyclophosphamide
patients will receive a standard pre-conditioning regime with cyclophosphamide 0.8-1.0g/m2/day IV for 2 days(Day-5 to day-4).
DRUGFludarabine
Fludarabine 25mg/m2/day IV for 3 days (Day-5 to day-3).
BIOLOGICALCART-19 cells
CART-19 cells will be administered using a split dose on day0(10%), 1(30%), and 2(60%) after completion of the chemotherapy.
Sponsors
The Beijing Pregene Science and Technology Company, Ltd.
Henan Cancer Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
4 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
1. 4 years to 70 years, expected survival \> 3 months 2. CD19 positive B-cell acute lymphoblastic leukemia 3. Karnofsky Performance Status (KPS) \>70 4. Relapsed after allogeneic or autologous stem cell transplantation (SCT); 5. 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） 6. No serious allergic constitution 7. No other serous diseases that conflicts with the clinical program 8. No other cancer history 9. No serious mental disorder 10. Informed consent is signed by a subject or his lineal relation.
Exclusion criteria
1. Pregnant or lactating women; (female participants of reproductive potential must have a negative serum or urine pregnancy test) 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive 3. Active hepatitis B or hepatitis C infection 4. Recent or current use of glucocorticoid or other immunosuppressor 5. With severe cardiac, liver, renal insufficiency, diabetes and other diseases 6. Transaminase \>2.5 ULN, Bilirubin \>3 ULN，Creatinine\>1.25 ULN 7. Participate in other clinical research in the past three months; previously treatment with any gene therapy products 8. 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. | 6 months | monitor the occurrence of study related adverse events. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| efficacy | 2 years | anti-tumor activity of CART-19 cells will be determined in a follow-on study |
| duration of CART-19 | 2 years | Determine duration of in vivo survival of CART-19 cells. |
Countries
China
Contacts
Primary ContactYongping Song
Outcome results
None listed