Relapsed or Refractory B-Cell Lymphoma
Conditions
Interventions
Case series:CD19-Targeted Chimeric Antigen Receptor (CAR)-Modified T Cells
Sponsors
Istitute of Hematology, Union Hospital,Tongji Medical College,Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Histologically or cytologically diagnosed B-cell lymphoma, including diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, follicular lymphoma, etc; 2. Relapsed or Refractory B-Cell Lymphoma, including PD or SD for less than 6 months after first-line chemotherapy, or disease progression or relapse after ASCT; 3. At least one measurable objective tumor lesion; and suitable for assessing tumor response and progression based on revised IWG efficacy evaluation criteria; 4. Aged 18 or older male or female; 5. Estimated survival time = 3 months; 6. ECOG score 0-1 points; 7. Adequate venous access, peripheral blood mononuclear cell collection without contraindications; 8. Laboratory test indicators: neutrophils = 1.0×10^9/L, platelets = 50×10^9/L, lymphocytes = 0.7×10^9/L; total bilirubin = 2 times the upper limit of normal, transaminase (AST, ALT) = 2.5 times the upper limit of normal (5 times the upper limit of normal if there are liver metastases), serum creatinine = 1.5 times the upper limit of normal; 9. Women of childbearing age who have a negative pregnancy test or male patients must take effective and reliable methods of contraception until the end of the treatment period; 10. Voluntarily participate in this experiment and sign informed consent by themself, or legally authorized representative.
Exclusion criteria
Exclusion criteria: 1. ASCT treatment is given within 6 weeks prior to the signing of the informed consent form; 2. Previously receiving CAR T cells or genetically modified T cell therapy; 3. Current medical history or previous medical history shows brain metastasis, or detection of cerebrospinal fluid cancer cells, or have central nervous system lymphoma; 4. With a history of epilepsy or other central nervous system diseases; 5. Have active viral or bacterial infections and are not controlled by treatment; 6. People with HIV or syphilis serological reaction positive, uncontrolled hepatitis B virus or hepatitis C virus infection; 7. Patients with immune-related diseases, such as autoimmune diseases, organ transplants, etc., or long-term use of immunosuppressive drugs such as glucocorticoids; 8. The presence of clinically significant cardiovascular disease, such as uncontrolled or symptomatic arrhythmias, congestive heart failure or myocardial infarction within recent six months, or heart disease with cardiac function in any grade 3 (moderate) or 4 ( severe) (according to the New York Heart Association (NYHA) Functional Classification System); 9. Any situation that the researchers believe may increase the risk of patients or interfere with test results. 10. Received anti-cancer treatment (including clinical drug trials) during the following period before enrollment 1) The time of chemotherapy withdrawal before enrollment was less than the treatment period of the chemotherapy regimen; 2) Anti-tumor treatment (including radiotherapy, chemotherapy, small molecule, biological therapy or immunotherapy) within 4 weeks before the start of treatment or less than 5 half-life of the drug, whichever is shorter (but the shortest time is not less than 21 days); 11. Pregnant or lactating women.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| white blood cell;platlet;hemoglobin;interferon-?;tumor necrosis factor-a;interleukin-6;interleukin-10;interleukin-2;C reactive protein;chimeric antigen receptor T-cell; | — |
Countries
China
Contacts
Public ContactYu Hu
Istitute of Hematology, Union Hospital, Tongji Medical College,Huazhong University of Science and Technology
Outcome results
None listed