Sequential CD19 and CD22 CAR-T Therapy for Newly Diagnosed Ph- B-ALL

• Status: Recruiting
• Trial end date: 2025-01-31
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Zhejiang University
• Collaborator: Yake Biotechnology Ltd.

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.