Leukemia, Lymphocytic, Acute, B-Cell, Leukemia, Lymphocytic, Chronic, B-Cell, Lymphoma, B-Cell
Conditions
Brief summary
The clinical study of CART19 Cells treatment for MRD of B Cell Malignancies and then auto-HSCT
Detailed description
The clinical study of the chimeric antigen receptor T cells (CART Cells) treatment for minimal residual disease(MRD) of B Cell Malignancies and then autologous hematopoietic stem cell transplantation(auto-HSCT).
Interventions
BIOLOGICALCART19 cell and auto-HSCT
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T (CART19) Cells treatment for Adult Patient with Minimal Residual Disease(MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT). Subjects will receive 0.5-4 x 10\^8 transduced CAR T cells as a split dose over three days as follows:Day 0, 10% fraction: 0.5-4x10\^7 CART19 cells, Day 1, 30% fraction: 1.5x10\^7-1.2x10\^8 CART19 cells, Day 2, 60% fraction: 3x10\^7-2.4x10\^8 CART19 cells. Auto-HSCT will be made about 6 mouths after CART19 cell is infused back to the patient.
Sponsors
Shenzhen Second People's Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
Phase 1 Clinical Study of CD19-directed Chimeric Antigen Receptor-modified T Cells (CART19) treatment for the Patients with Minimal Residual Disease (MRD) of B Cell Malignancies and then Autologous Hematopoietic Stem Cell Transplantation(Auto-HSCT).
Eligibility
Sex/Gender
ALL
Age
14 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1\. Patients with CD19+, B cell Acute Lymphocytic Leukemia(B-ALL), B cell Chronic Lymphocytic Leukemia(B-CLL), B cell Lymphoma，who have 0.01%≤MRD\<10% during upfront treatment 2. Patients must be within 12 months of initial B-ALL, B-CLL, B cell Lymphoma diagnosis 3. Patients must have a measurable or evaluable disease at the time of enrollment, which may include any evidence of disease including minimal residual disease detected by flow cytometry, cytogenetics, or polymerase chain reaction (PCR) analysis 4. Age 14 years to 75 years 5. Adequate organ function defined as: 1. AST and ALT ≤ 3 times upper limit of normal range for age, 2. Serum creatinine ≤ 1.6 mg/dl, 3. Direct bilirubin ≤2.0 mg/dl, 4. Adequate pulmonary function defined as ≤ grade 2 dyspnea and ≤ grade 2 hypoxia, 5. Cardiac Left Ventricle Ejection Fraction (LVEF) ≥ 40% confirmed by ECHO/MUGA. 6. Patients with CNS disease will be eligible if CNS disease is responsive to therapy 7. Expression of CD19 on leukemic blasts demonstrated by flow cytometry or immunohistochemistry of bone marrow or peripheral blood 8. Adequate performance status defined as ECOG Performance Status 0 or 1 9. Provides written informed consent 10. Subjects of reproductive potential must agree to use acceptable birth control methods, as described in protocol
Exclusion criteria
1. Active, uncontrolled infection 2. Active hepatitis B or hepatitis C 3. HIV Infection 4. Class III/IV cardiovascular disability according to the New York Heart Association Classification 5. Subjects with clinically apparent arrhythmia or arrhythmias who are not stable on medical management within two weeks of enrollment 6. Pregnant or nursing (lactating) women Patients with a known history or prior diagnosis of optic neuritis or other 7. immunologic or inflammatory disease affecting the central nervous system, and unrelated to leukemia or previous leukemia treatment.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| CART19 Cells Treatment of MRD of B Cell Malignancies and Then Auto-HSCT | day 28 | The incidence of conversion of minimal residual disease (MRD) to \<0.01% after CART19 therapy in patients with MRD of B Cell Malignancies during upfront treatment |
Countries
China
Contacts
Primary ContactWeihong Chen, M.D., Ph.D.
Backup ContactXin Du, M.D., Ph.D.
Outcome results
None listed