B Acute Lymphoblastic Leukemia, Ph-Negative ALL, High Risk Acute Lymphoblastic Leukemia
Conditions
Brief summary
Clinical trial for the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in adult patients with newly diagnosed high-risk and Ph- B-ALL
Detailed description
To evaluate the safety and efficacy of induction chemotherapy with VA regime and bridging CD19CD22 CAR-T therapy in Adult patients with newly diagnosed high-risk and Ph- B-ALL in this prospective, single arm study.
Interventions
Azacitidine Injection 75mg/square meter/day, day1-7, subcutaneous injection
DRUGVenetoclax
Venetoclax 100mg day 1, 200mg day 2, 400mg d3-d21, oral
DRUGCD19CD22 CAR-T
After induction chemotherapy with Azacitidine+Venetoclax, each subject receives CD19CD22 CAR-T cells by intravenous infusion
Sponsors
The First Affiliated Hospital of Soochow University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
1. Age≥18 and ≤65 years old 2. Newly diagnosed and high risk B-ALL according to the 2022 WHO classification 3. The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-; 4. Anticipated survival time more than 12 weeks; 5. Those who voluntarily participated in this trial and provided informed consent.
Exclusion criteria
1. History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases; 2. Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past; 3. Pregnant (or lactating) women; 4. Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis); 5. Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus 6. Previously treated with any CAR-T cell product or other genetically-modified T cell therapies; 7. Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl; 8. Other uncontrolled diseases that were not suitable for this trial; 9. Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate | The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion | MRD Negative Remission Rate after CD19CD22 cell therapy |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Complete Remission Rate of VA regime | The cycle of VA regime is day 21; Effect evaluation was day 7 after VA regime | Complete Remission Rate after VA regime |
| Complete Molecular Remission Rate | The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was day 21 after CD19CD22 cells infusion | Complete Molecular Remission Rate after CD19CD22 CAR-T cell therapy |
| Overall survival (OS) | The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion | From the first infusion of CD19CD22 cells to death or the last visit |
| Leukemia-free survival (LFS) | The cycle of CD19CD22 cell therapy is day 2-4; Effect evaluation was 2 years after CD19CD22 CAR-T cells infusion | Up to 2 years after CD19CD22 CAR-T cells infusion |
Countries
China
Outcome results
None listed