Relapsed and refractory acute B lymphocytic leukemia
Conditions
Interventions
Sponsors
the First Affiliated Hospital, Zhejiang University School of Medicine
Eligibility
Sex/Gender
All
Age
8 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Patients with R/R B-ALL who meet the following criteria: (1) leukemia cells with positive CD19/CD22 expression; (2) Patients with high tumor burden and cannot treat with HSCT; (3) Relapse after transplantation and DLI is ineffective; (4) Refractory patients with repeated positive MRD; (5) Patients with extramedullary lesions that are difficult to be cured by chemoradiotherapy; 2. Expected survival >12 weeks; 3. Male or female aged 18-75 years; 4. Transplanted patients regardless of their previous treatment; 5. Women of childbearing age who had a negative urine pregnancy test before the start of administration and agreed to use effective contraceptive measures during the study period until the last follow-up; 6. Patients or their legal guardians volunteer to participate in the study and sign the informed consent.
Exclusion criteria
Exclusion criteria: Subjects with any of the following exclusion criteria were not eligible for this trial: 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. Active infection of hepatitis B virus or hepatitis C virus; 6. Concurrent therapy with systemic steroids within 2 weeks prior to screening, except for the patients recently or currently receiving in haled steroids; 7) Those who have used any gene therapy products before; 8) inadequate amplification ability (2.5mg/dl, or ALT / AST > 3 times of normal amounts, or bilirubin>2.0 mg/dl; 10) Patients who have other uncontrolled diseases and are considered unsuitable to enroll; 11) Patients with HIV infection; 12) Any circumstances that the investigator believes may increase the risk to the subject or interfere with the results of the test.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| dose-limited toxicity;adverse event incidence rate;titer of auto-antibody; | — |
Countries
China
Contacts
Public ContactHe Huang
the First Affiliated Hospital, Zhejiang University School of Medicine
Outcome results
None listed