Refractory or relapsed B-cell lymphoma
Conditions
Interventions
Sponsors
Shaanxi Provincial People's Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. >=18 years old; 2. Signed informed consent (informed consent signed by the legal guardian of the child patient or the incapacitated person); 3. The estimated survival time is >= 3 months; 4. Indication: Diagnosed as refractory/recurrent aggressive B-cell lymphoma with positive target markers (lymphoma cells express therapeutic target antigens, such as CD19/CD20)(Standards refer to NCCN guidelines, 5th edition,2017); Recurrent invasive B-cell lymphoma refers to patients with invasive B-cell lymphoma who have experienced an increase in tumor burden after reaching CR. Refractory invasive B-cell lymphoma refers to invasive B-cells that have not reached CR after 4 courses of standard chemotherapy. 5. According to the revised evaluation criteria for the efficacy of IWG malignant lymphoma, at least 1 measurable lesion exists (Cheson 2007), including minimal residual disease; 6. Brain MRI and CSF examination showed no evidence of CNS lymphoma; 7. Organ function: (1) Cardiac function: left ventricular ejection fraction >40% in the last month (echocardiography); (2) Liver function: Alanine aminotransferase and aspartate aminotransferase 92%; 8. ECOG score <= 3; 9. Women of childbearing age must test negative for blood pregnancy within 7 days, and subjects of childbearing age must use appropriate contraceptive methods both during the trial and for 3 months after the trial (women who have undergone sterilization or who have been menopausal for at least 2 years are considered infertile).
Exclusion criteria
Exclusion criteria: 1. Suffering from other organ malignant tumors (requiring treatment); 2. Active heart disease: a history of uncontrolled or symptomatic angina; Myocardial infarction less than 6 months after enrollment; A history of arrhythmia requiring medical treatment or severe clinical symptoms; Uncontrolled or symptomatic congestive psychological failure (> NYHA2 level); 3. Active infection requiring two or more antibiotics; 4. AIDS patients or immune deficiency patients caused by any reason; 5. Inability to understand or follow the study protocol for epilepsy, dementia, or other psychiatric conditions requiring medical treatment; 6. Substance abuse, medical, psychological, or social conditions that may interfere with the subject's participation in the study or evaluation of the study results; 7. Pregnant or lactation patients; 8. Subjects requiring systemic corticosteroid therapy (>=5mg/d of prednisone or equivalent dose of another corticosteroid) or other immunosuppressive drugs during the study period, except for those used to treat adverse events; 9. Participating in other intervention studies; 10. Primary CNS invasive B-cell lymphoma or CNS invasive B-cell lymphoma; 11. The researchers deemed unsuitable for the group.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse events;Overall response rate;Event-free survival;Relapse-free survival;Duration of response;CAR copys;Level of cytokines;Lymphocyte subset; | — |
Countries
China
Contacts
Public ContactYi Wang
Shaanxi Provincial People's Hospital
Outcome results
None listed