B-cell Acute Lymphoblastic Leukemia
Conditions
Keywords
B-cell acute lymphoblastic leukemia, CD19 CAR-T
Brief summary
This is a single center, single arm, open-lable phase 1 study to determine the safety and efficacy of CD19-CAR-T cells in patients with relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL).
Detailed description
In this single-center, open-label, nonrandomized, no control, prospective clinical trial, no less than 18 CD19+ B-cell relapsed or refractory acute B-cell lymphoblastic leukemia (R/R B-ALL) patients will be enrolled. Side effects of CD19 CAR T cells therapy will be monitored. The purpose of current study is to determine the clinical efficacy and safety of CD19 CAR T cells therapy in patients with R/R B-ALL.
Interventions
BIOLOGICALCD19 CAR-T cells
T cells purified from the PBMC of subjects, transduced with 4-1BB/CD3-ζ lentiviral vector, expanded in vitro for future administration.
Sponsors
Tianjin Mycure Medical Technology Co., Ltd
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Intervention model description
single-center, open-label, nonrandomized, no control, prospective clinical trial
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. More than 1 year; 2. CD19 positive B-cell acute lymphoblastic leukemia; 3. Important organ function is satisfied: cardiac ultrasound indicates cardiac ejection fraction ≥50%, no obvious abnormality in ECG; blood oxygen saturation ≥90%; creatinine clearance calculated by Cockcroft-Gault formula ≥40ml/min; ALT and AST≤ 5 times normal range, total bilirubin ≤ 34.2 μmol / L. 4. Expected to survive for more than 3 months; 5. Informed consent is signed by a subject or his lineal relation.
Exclusion criteria
1. Recent or current use of glucocorticoid or other immunosuppressor; 2. Uncontrolled active infection, HIV infection, syphilis serology reaction positive; 3. Has a graft-versus-host response and requires the use of immunosuppressants； 4. Drug uncontrollable central nervous system leukemia； 5. Pregnant or lactating female； 6. The patient did not agree to use effective contraception during the treatment period and for the following 1 year； 7. A history of other malignant tumors; 8. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of adverse events | 6 months | Percentage of participants with adverse events |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| complete remission rate | 6 months | The percentage of participants who achieved complete remission (CR) over all participants (CRR). |
| objective remission rate | 6 months | The percentage of participants who achieved complete remission (CR) and partial remission over all participants (ORR). |
Countries
China
Contacts
Primary ContactChaoting Zhang, PhD
Outcome results
None listed