refractory/relapse B cell lymphoma,acute B lymphoblastic leukemia and chronic B lymphoblastic leukemia
Conditions
Interventions
Case series:Case series
Sponsors
Ludaopei Medical Group
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patient with CD19+ r/r B-cell lymphoma,acute B lymphocytic leukemia and Chronic B lymphocytic luekemia,including patients with relapse CD19+ B-cell malignacies who had previously been adminstrated by murine-resourced CD19CAR-T; 2. Patient with MRD-positive refractory/relapse B cell lymphoma,acute B lymphoblastic leukemia and chronic B lymphoblastic leukemia; 3. Aged 1 to 75 years; 4. KPS>40 5. At least 2 weeks or 5 drug half-lives,whichever is shorter.must have elapsed since any prior systemic therapy at the time the subject is planned for leukapheresis, except for systemic inhibitory/stimulatory immune checkpoint therapy; 6. Women of childbearing potential must have a urine pregnancy test taken and proven negative prior to the treatment. All patients agree to use reliable methods of contraception during the trial period and throughout the last follow-up visit; 7. Participation in the clinical trials should be voluntary with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with hypervolemia (white blood cell count> 50 x 10^9 / L) or rapidly progressive disease that in the estimation of the investigators and sponsors would compromise the ability to complete the study; 2. History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except with 3 years or longer of cure); 3. Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary); 4. Patients with positive results for HIV, HBV, HCV tests; 5. With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement; 6. History of myocardial infarction, cardiac angioplasty or stenting, unstable angina, or other clinically significant cardiac diseases within 12 months of enrollment, or with cardiac atrial or cardiac ventricular lymphoma; 7. Patients that are receiving anticoagulant therapy or have evere coagulation disorders; 8. Any medical condition that in the judgement of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study; 9. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 10. Female patients who are pregnant or breastfeeding; 10. Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 co-stimulation; 12. Patients with any uncontrolled diseases which is unsuitable for enrollment; 13. Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study; 14. Patients who have been enrolled in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Complete remission rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactPeihua Lu; Zhiguo Chen
Hebei Yanda Ludaopei Hospital
Outcome results
None listed