Acute B-lymphoblastic leukemia
Conditions
Interventions
Experimental group:CART cell injection
Sponsors
Peking University Shenzhen Hospital
Eligibility
Sex/Gender
All
Age
3 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Age >=3 and = 30%; 5. Subjects with a negative (Ph-) chromosome in Philadelphia; or a subject who could not tolerate tyrosine kinase inhibitor (TKI) therapy or did not respond to two TKI treatments (t315i mutants could receive one TKI treatment without response); 6. Serum total bilirubin = left ventricular ejection fraction (LVEF); 8. The subject did not receive radiotherapy, chemotherapy, monoclonal antibody therapy or other anti-tumor therapy within 1 week before screening; 9. Estimated survival of more than 3 months; 10. ECOG score of 0-2; 11. The subject or his/her legal guardian voluntarily participates in this test and signs an informed consent form.
Exclusion criteria
Exclusion criteria: 1. Diagnosis of chronic myeloid leukemia lymphoblastic crisis according to WHO classification; 2. Have hereditary syndromes such as Fanconi anemia, Kostmann syndrome, Shwachman syndrome or any other known bone marrow failure syndrome; 3. Those who have a history of allergy to any one of the ingredients in the cell product; 4. Uncontrolled active CNSL; 5. Subjects with grade III or IV cardiac insufficiency according to the NYHA Cardiac Function Grading Standards; 6. Myocardial infarction, cardiovascular angioplasty or stenting, unstable angina or other serious heart diseases clinically within 12 months of admission; 7. ECG shows that there is a significant prolongation of the QT interval, and those who have previously suffered from serious heart disease such as severe arrhythmias; 8. Severe active infection and not effectively controlled (except for simple urinary tract infections and bacterial pharyngitis); 9. The subject has a history of other primary cancers, except in the following cases: (1) Non-melanomas such as cutaneous basal cell carcinoma that have been cured by resection; (2) Cervical carcinoma in situ, local prostate cancer, and catheter carcinoma in situ with a disease-free survival = 2 years after adequate treatment; 10. Subjects with autoimmune diseases who need treatment, subjects with immunodeficiency or immunosuppressant therapy; 11. Have graft-versus-host disease (GvHD); 12. Live vaccination within 4 weeks prior to screening; 13. The subject has a history of alcoholism, drug abuse or mental illness; 14. If the subject is positive for hepatitis B surface antigen and the upper limit of the normal value of hepatitis B virus PCR > during screening, the antibodies of hepatitis C, AIDS and syphilis are positive and the syphilis DNA test exceeds the upper limit of normal value; 15. Those who must use steroids during CAR-T infusion (except for those who use topical or inhaled steroids); 16. Screening of those who have participated in other clinical trials within 2 weeks before; 17. Pregnant, lactating women and subjects with fertility who are unable to use effective contraception (both men and women); 18. 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 |
|---|---|
| Blood Routine;Dose Limiting Toxicity;Treatment Emergent Adverse Events, TEAE; | — |
Secondary
| Measure | Time frame |
|---|---|
| CR (complete response) /CRi (complete response with incomplete hemocyte recovery) and total response rate (ORR) at 1 and 3 months after treatment;Total MRD-negative response rate at 1 and 3 months after treatment (MRD-ORR);Duration of remission, DOR;Overall response rates at 6 and 12 months;Event-free survival (EFS) at 6 and 12 months;Overall survival at 6 and 12 months (OS); | — |
Countries
China
Contacts
Public ContactHongyu Zhang
Peking University Shenzhen Hospital
Outcome results
None listed