Status:
UNKNOWN
Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL
Lead Sponsor:
Zhejiang University
Collaborating Sponsors:
Yake Biotechnology Ltd.
Conditions:
B-Cell Acute Lymphoblastic Leukemia, Adult
Eligibility:
All Genders
15+ years
Phase:
PHASE1
PHASE2
Brief Summary
Clinical Trial for the Safety and Efficacy of Sequential CD19 and CD22 CAR-T Therapy for Adult Patients With Newly Diagnosed Ph Chromosome Negative B-cell Acute Lymphoblastic Leukemia
Detailed Description
This is a prospective, single arm study. To evaluate the safety and efficacy of sequential CD19 and CD22 CAR-T cells in the treatment of adult newly diagnosed Ph chromosome negative B-cell acute lymph...
Eligibility Criteria
Inclusion
- Age≥15 years old
- Newly diagnosed B-cell acute lymphoblastic leukemia according to the 2016 WHO classification
- The immunophenotype of leukemia cells were CD19 and CD22 positive
- Ph- or Ph- like negative
- 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);
- Active infection of hepatitis B virus or hepatitis C virus;
- Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving inhaled steroids;
- 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;
- Patients with HIV infection;
- Any situations that the investigator believes may increase the risk of patients or interfere with the results of study.
Key Trial Info
Start Date :
January 31 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 31 2025
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT04740203
Start Date
January 31 2021
End Date
January 31 2025
Last Update
February 5 2021
Active Locations (1)
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1
The First Affiliated Hospital, College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China, 310003