B-cell lymphoma
Conditions
Interventions
Sponsors
Tianjin First Central Hospital
Eligibility
Sex/Gender
All
Age
14 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. All subjects or legal guardians must personally sign the informed consent form approved by the ethics committee before starting any screening procedure; 2. B-cell lymphoma patients aged 14 to 80 years (excluding boundary values); 3. Meet the clinical criteria for refractory and relapsed B-cell lymphoma, and the definition of refractory includes: no response to the last treatment (PD for the last response to the last treatment regimen; SD for the last response to the treatment and maintained for less than 6 months); unsuitable or unwilling to undergo autologous stem cell transplantation, or ASCT refractory. Subject has been adequately previously treated, and treatment history includes at least: anti-CD20 monoclonal antibody (rituximab), unless the investigator determines that the tumor is CD20 negative; an anthracycline-containing chemotherapy regimen; as amended The IWG Malignant Lymphoid Response Evaluation Criteria (2007 edition), with at least one measurable lesion at baseline; 4. Expected survival period >= 12 weeks; 5. Baseline ECOG (Eastern Cooperative Oncology Group) score of 0 or 1; 6. Adequate organ function: 7. Hemodynamically stable and left ventricular ejection fraction (LVEF) >= 45% as determined by echocardiography or multi-channel radionuclide angiography (MUGA); 8. Adequate bone marrow reserve without blood transfusion, defined as: absolute neutrophil count (ANC) > 1.000/mm3; absolute lymphocyte count (ALC) >= 300/mm3; platelets >= 50.000/mm3; hemoglobin > 8.0g/dl; 9. There must be cells collected from non-mobilized apheresis or peripheral blood for CAR-T cell production; 10. Patients who use the following drugs need to meet the following conditions: (1) Steroids: The use of therapeutic doses of steroids must be discontinued 1 week before CAR-T infusion. However, physiological replacement doses of steroids are permitted; (2) Immunosuppression: any immunosuppressive drugs must be stopped >= 2 weeks before enrollment; (3) Anti-proliferative therapy other than lymphodepleting chemotherapy within two weeks before infusion; (4) CD20 antibody-related therapy must be stopped within 2 weeks or 5 half-lives (whichever is longer) before the infusion; (5) CNS disease prevention must be stopped 1 week before CAR-T infusion (eg, intrathecal methotrexate). 11. Females of childbearing age and all male subjects must agree to use highly effective contraceptive methods for at least 12 months after CAR-T infusion, and until 2 consecutive PCR tests show that there are no more CAR-T cells in the body.
Exclusion criteria
Exclusion criteria: 1. Patients with current or history of central nervous system diseases, such as seizures, cerebrovascular ischemia/bleeding, dementia, cerebellar disease or any autoimmune disease associated with the central nervous system; 2. Patients who have received chemotherapy other than lymphodepleting chemotherapy within 2 weeks before CAR-T infusion; 3. Screen patients who have received other study drugs within 2 weeks; 4. Patients who received radiation therapy within 1 week before infusion; 5. Active hepatitis B (defined as hepatitis B virus DNA detection value > 500 IU/mL) or hepatitis C (HCV RNA positive) patients; 6. HIV-positive or Treponema pallidum-positive patients; 7. Patients with uncontrolled acute life-threatening bacterial, viral or fungal infection (eg. positive blood culture <= 72 hours before infusion); 8. Patients with unstable angina and/or myocardial infarction within 6 months before screening; 9. Patients with other uncured malignant tumors at the same time; 10. Pregnant or lactating female patients; 11. Patients with arrhythmia that are not controlled by medical management; 12. Patients who received oral anticoagulation within 1 week before CAR-T cell infusion; 13. Suffering from active neuro-autoimmune or inflammatory conditions (eg Guillian-Barre syndrome, amyotrophic lateral sclerosis); 14. Other conditions that the investigator believes should not participate in this clinical trial, such as poor compliance.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Safety;Progression Free Survival; | — |
Countries
China
Contacts
Public ContactZhao Mingfeng
Tianjin First Central Hospital
Outcome results
None listed