Relapsed/refractory central nervous system involvement of non-Hodgkin lymphoma
Conditions
Interventions
Sponsors
Beijing Boren Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Can understand this test and have voluntarily signed informed consent; 2. Aged >=18 years at the time of screening, no gender limit; 3. ECOG score 0-2; 4. Estimated survival time is more than 12 weeks; 5. Patients meeting the following diagnostic and therapeutic requirements during screening: (1) Confirmed cytological or histopathological diagnosis of central nervous system B-cell lymphoma (CNSL) according to WHO2017 criteria, as follows (pathological confirmation) : 1) Primary central nervous system lymphoma; 2) Diffuse large B-cell lymphoma with central invasion (not specifically), high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, follicular lymphoma, marginal zone lymphoma, mantle cell lymphoma, Richter's syndrome, and Burkitt's lymphoma; (2) Previous treatment history includes (one of the following conditions can be met) : 1) Patients with refractory and relapsed B-cell non-Hodgkin lymphoma with no remission and recurrence after standard first-line therapy and at least 2 courses of second-line therapy; 2) Patients with B-cell non-Hodgkin lymphoma who recurred after stem cell transplantation were not affected by other therapies previously used; 3) Patients with B-cell non-Hodgkin lymphoma who are clearly diagnosed but cannot receive conventional treatment due to their own reasons, such as radiotherapy, chemotherapy, targeted therapy, and stem cell transplantation; 6. Venous access required for collection can be established without contraindications for white blood cell collection; 7. Lesions were punctured before enrollment, and there were expressed targets in pathological immunohistochemistry, such as CD19, CD22, CD20, CD70, CD79b, etc.
Exclusion criteria
Exclusion criteria: 1. Patients with malignant tumors other than diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL), transformed large B-cell lymphoma (follicular lymphoma, chronic lymphocytic leukemia, marginal zone lymphoma), high-grade B-cell lymphoma (HGBCL), and primary central nervous system lymphoma within 5 years prior to screening. Fully treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, ductal carcinoma in situ after radical surgery, and thyroid cancer after radical surgery are excluded; 2. Central nervous system involvement of symptomatic patients; The central foci were located at high-risk sites, such as medulla bulbar and thalamus. Single lesion size > 3cm; Cerebrospinal fluid tumor cells > 2*10^6/L; 3. Patients who had used CAR T cell therapy or other gene modified cell therapy before screening; 4. Any unstable systemic disease: These include, but are not limited to, active infections (other than local infections), unstable angina, cerebrovascular accidents or transient ischemia (within 6 months prior to screening), myocardial infarction (within 6 months prior to screening), congestive heart failure (New York Heart Association [NYHA] classification >=III, severe arrhythmias requiring medication, liver, kidney or metabolic diseases; 5. Any other controlled active disease that prevents participation in the trial; 6. Anything that the investigator believes would compromise the safety of the patient or interfere with the purpose of the study; 7. Patients who are pregnant or nursing, or who plan to become pregnant during or within 1 year after treatment, or male patients whose partner plans to become pregnant within 1 year after cell transfusion; 8. Active or uncontrolled infections (other than simple urinary tract infections or upper respiratory tract infections) requiring systemic treatment were present during or within 14 days prior to enrollment; 9. Patients who were receiving systemic steroid therapy prior to screening and who were determined by the investigator to require long-term use of systemic steroid therapy during treatment (other than inhalation or topical use); And patients treated with systemic steroids (except for inhalation or topical use) within 72 hours prior to cell transfusion; 10. Patients suffering from diseases that affect the signing of written informed consent or the inability to comply with study procedures; Or unwilling or unable to comply with research requirements; 11. Known presence of HIV infection (anti-HIV positive), active hepatitis B (positive for HBsAg, or positive for HBcAb and positive for HBV-DNA PCR), or active hepatitis C (positive for HCV antibody and positive for HCV-RNA PCR), Or syphilis infection (positive for anti-TP); 12. Had received major surgery within 4 weeks prior to screening and was assessed by the researchers as not suitable for inclusion; 13. Researchers consider it inappropriate to participate in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR); | — |
Secondary
| Measure | Time frame |
|---|---|
| Duration of response;Progression-free survival;Overall survival; | — |
Countries
China
Contacts
Public ContactHu Kai
Outcome results
None listed