Status:
UNKNOWN
CD19CD22 CAR-T Therapy in Patients With High-Risk B Acute Lymphoblastic Leukemia (B-ALL).
Lead Sponsor:
The First Affiliated Hospital of Soochow University
Conditions:
B Acute Lymphoblastic Leukemia
Ph-Negative ALL
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
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, sin...
Eligibility Criteria
Inclusion
- Age≥18 and ≤65 years old
- Newly diagnosed and high risk B-ALL according to the 2022 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive and Ph-;
- Anticipated survival time more than 12 weeks;
- Those who voluntarily participated in this trial and provided informed consent.
Exclusion
- History of craniocerebral trauma, conscious disturbance, epilepsy, cerebrovascular ischemia, and cerebrovascular hemorrhagic diseases;
- Electrocardiogram shows prolonged QT interval, severe heart diseases such as severe arrhythmia in the past;
- Pregnant (or lactating) women;
- Patients with severe active infections (excluding simple urinary tract infection and bacterial pharyngitis);
- Human immunodeficiency virus (HIV) positive; Active infection of hepatitis B virus or hepatitis C virus
- Previously treated with any CAR-T cell product or other genetically-modified T cell therapies;
- Creatinine\>2.5mg/dl, or ALT / AST \> 3 times of normal amounts, or bilirubin\>2.0 mg/dl;
- Other uncontrolled diseases that were not suitable for this trial;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
April 20 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 10 2025
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06078306
Start Date
April 20 2024
End Date
September 10 2025
Last Update
April 22 2024
Active Locations (1)
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1
Xiaowen Tang
Suzhou, Jiangsu, China, 215000