Overview

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

Status:
Recruiting
Trial end date:
2025-03-05
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 Positive 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:

Ageā‰„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.