refractory/relapse B cell lymphoma, acute B lymphoblastic leukemia, and chronic B lymphoblastic leukemia
Conditions
Interventions
Sponsors
Xuanwu Hospital Capital Medical University
Eligibility
Sex/Gender
All
Age
15 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Patients with CD19+ relapse/refractory and drug-resistant B-cell lymphoma, acute B lymphomatic leukemia, and chronic B lmyphomatic leukemia; 2. Patients with relapsed MRD-positive refractory acute lymphoblastic leukemia and chronic lyphoblastic leukemia, and extramedullary leukemia (excluding central nervous system leukemia); 3. Aged 15 to 65 years; 4. Subjects with Karnofsky score=70 and estimated survival of more than 3 months; 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. Absolute neutrophils count>1.5x10^9/L; 7. Absolute platelets count>50x10^9/L; 8. Absolute lymphocyte count=0.15 x10^9/L; 9. ALT/AST 92% on room air; 15. Patients have no significant central nervous system leukemia (symptoms, signs, imaging, cerebrospinal fluid), and subjects with lymphoma should not show central nervous system metastasis; 16. 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; 17. Participation in the clinical trials should be voluntary with signed informed consent.
Exclusion criteria
Exclusion criteria: 1. Patients with estimated survival of less than 3 months; 2. Patients with central nervous system leukemia (judged by symptoms, signs, imaging or cerebrospinal fluid tests); 3. 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; 4. History of melanoma skin cancer or other primary tumors (eg, cervical cancer, bladder cancer, breast cancer) (except with 3 years or longer of cure); 5. Patients with fungal, bacterial, viral, or other uncontrollable infections or infections requiring Level 4 isolation (UTI or inoculation assays may be performed if necessary); 6. Patients with positive results for HIV, HBV, HCV tests; 7. With CNS disorders such as cerebrovascular ischemia/hemorrhage, dementia, cerebellar disease, or autoimmune disease with CNS involvement; 8. 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; 9. Patients that are receiving anticoagulant therapy or have severe coagulation disorders; 10. Any medical condition that in the judgement of the sponsors/investigators is likely to interfere with assessment of safety or efficacy of study; 11. History of severe immediate hypersensitivity reaction to any of the agents used in this study; 12. Female patients who are pregnant or breastfeeding; 13. Subjects who were administered by systemic steroid medications within 2 weeks prior to treatment (unless inhaled steroids are recently or currently in use); 14. Feasibility assessment during screening demonstrates <30% transduction of target lymphocytes, or insufficient expansion (< 5-fold) in response to CD3/CD28 co-stimulation; 15. Patients with any uncontrolled diseases which is unsuitable for enrollment; 16. Any situation that is considered to potentially increase the risk of the subject or interfere with the outcome of the study; 17. Patients who have been enrolled in other clinical studies.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety; | — |
Secondary
| Measure | Time frame |
|---|---|
| Complete remission rate;Progression Free Survival;Overall Survival; | — |
Countries
China
Contacts
Public ContactLi Su, Zhiguo Chen
Xuanwu Hospital Capital Medical University
Outcome results
None listed