CD20+ r/r DLBCL
Conditions
Interventions
Experimental:hpNK cell injection
Experimental:Rituximab
Experimental:Other chemotherapy
Sponsors
The Affiliated Cancer Hospital of Guizhou Medical University
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1. Aged 18 to 70 years, expected survival period is greater than 3 months; 2. Histologically confirmed CD20-positive (CD20+) relapsed or refractory diffuse large B-cell lymphoma (DLBCL); 3. Have received 2 or more Rituximab combined chemotherapy treatments, with no intolerable side effects; 4. Eastern Cooperative Oncology Group (ECOG) performance status 0-2; 5. Reproductive males and females of childbearing age must agree to take effective contraceptive measures from the signing of the informed consent form until 180 days after the last administration of the study drug. Women of childbearing age include premenopausal women and women within 2 years after menopause. Women of childbearing age must have a negative pregnancy test within 21 days prior to the first study drug administration; 6. The patient himself agrees to participate in this clinical study and signs an informed consent form; 7. Lymphoma has at least one measurable lesion according to the Lugano 2014 standard, that is, according to the CT cross-sectional image, the length of the lymph node lesion is greater than 15mm, or the length of the extranodal lesion is greater than 10mm, and the FDG-PET examination is positive; 8. Liver and kidney function, heart and lung function meet the following requirements: (1) Serum creatinine 50%, no pericardial effusion or pleural effusion on ECHO examination; (3) Baseline blood oxygen saturation> 92%; (4) Total bilirubin <=1.5 ULN; (5) ALT and AST<=3 ULN.
Exclusion criteria
Exclusion criteria: 1. Primary central nervous system diffuse large B-cell lymphoma, or central nervous system (CNS) invasion; 2. Accompanied by active autoimmune diseases (such as systemic lupus erythematosus, rheumatoid arthritis, multiple sclerosis, Sjogrens syndrome, autoimmune thrombocytopenia, etc.); 3. Past cardiovascular events, such as myocardial infarction, or myocardial infarction, cardio-cerebral syndrome, severe arrhythmia, unstable angina, or poorly controlled arrhythmia (including QTc interval males >=450 ms) within 6 months before the trial , Female >=470 ms, QTc interval is calculated by Fridericia formula), uncontrolled hypertension, etc.; 4. Have had an allograft; 5. Those who have received anti-tumor vaccines, or those who have received immunostimulatory anti-tumor drugs within 4 weeks before signing the informed consent form, or those who have received anti-infective vaccines (such as influenza virus vaccine, Human papillomavirus vaccine); 6. Have received other unmarketed clinical investigational drug treatments within 4 weeks before screening; 7. History of other malignant tumors, severe diabetes and other major diseases; 8. Serious infectious diseases or viral diseases (measles, chickenpox, HIV positive, syphilis, active hepatitis B or C, etc.).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| DLT (Dose limited toxicity);AE & SAE type and frequencies;ECOG evaluation;ORR (Objective Response Rate); | — |
Secondary
| Measure | Time frame |
|---|---|
| DFS (Disease-free survival);PFS (Progression-Free Survival); | — |
Countries
China
Contacts
Public ContactYunhong Huang
The Affiliated Cancer Hospital of Guizhou Medical University
Outcome results
None listed