B-cell lymphoma.
Conditions
Interventions
Experimental group:CD19/CD20 Dual-CAR-T cells
Sponsors
Peking University Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Aged >=18 years old; 2. CD19+ and/or CD20+ B-cell lymphoma confirmed by cytology and histology, including but not limited to diffuse large B-cell lymphoma, follicular lymphoma grade 1-3, follicular lymphoma with large B Cell transformation, marginal zone lymphoma, mantle cell lymphoma, small B cell lymphoma, etc.; 3. Relapse or refractory after at least second-line treatment (primary mediastinal large B-cell lymphoma has undergone at least first-line treatment); 4. With evaluable target lesions : CT can measure target lesions: lymph nodes>1.5x1.0cm, extranodal lesions>1.0x1.0cm; 5. CD19 and/or CD20 positive; 6. ECOG score 0-2 points; 7. Good organ function: Blood routine: absolute neutrophil count (ANC) >= 1.5x109/L; hemoglobin (Hb) >= 90 g/L; platelet count (PLT) >= 75 x 10^9/L; Blood biochemistry: total bilirubin = 92% in indoor air environment; Heart function: Left ventricular ejection fraction (LVEF) > =50%. 8. Women of childbearing age (15-49 years old) must receive a pregnancy test within 7 days prior to initiation of treatment and the results are negative; male and female patients with fertility must use an effective contraceptive to ensure 3 months after discontinuation of treatment during the study period not pregnant inside; 9. Patients who voluntarily sign informed consent and are willing to comply with treatment plans.
Exclusion criteria
Exclusion criteria: 1. Active infections that are difficult to control; 2. Active hepatitis B, active hepatitis C or human immunodeficiency virus [HIV] positive ; 3. The tumor invades the central nervous system or primary CNS lymphoma;apheresis 4. Anti-GVHD treatment is being performed within 4 weeks before apheresis and cell infusion; 5. Have undergone major surgery within 4 weeks before screening; 6. Have undergone the following treatments: 1) Received chemotherapy within 7 days before apheresis; 2) The test drug has been used within 4 weeks before apheresis; 3) A therapeutic dose of corticosteroids has been used 7 days before apheresis or 72 hours before cell infusion, but physiological replacement, topical and inhaled steroids are allowed; 4) Received donor lymphocyte infusion (DLI) within 6 weeks before cell infusion; 5) Received radiotherapy within 6 weeks before apheresis. 6) Received autologous hematopoietic stem cell transplantation within 3 months before apheresis or allogeneic hematopoietic stem cell transplantation (HSCT) within 12 months; 7)Use CAR-T or other gene therapy products before joining the group; 7. History of epilepsy or other central nervous system diseases in the past or at the time of screening; 8. Toxicity or complications caused by previous intervention or treatment have not recovered to Grade 1 or below; 9. Clinically diagnosed as having severe thyroid dysfunction; 10. Suffer from active autoimmune diseases; 11. At least 2 years of history of other malignant tumors that have not been remission; 12. Interstitial pneumonia in the past or during screening; 13. A history of any of the following cardiovascular diseases occurred within 6 months of the screening period: NYHA heart function grade III or IV heart failure, cardiovascular angioplasty or stent, myocardial infarction, unstable angina, or other clinical symptoms Significant heart disease; 14. pregnant or lactating women; 15. The patient does not agree to use effective contraception during the treatment period and for the next 12 months; 16. The investigator believes that there are other factors that are not suitable for inclusion or influence the subject's participation or completion of the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Adverse Events;Objective remission rate;Relapse-Free Survival;T cell proliferation; | — |
Countries
China
Contacts
Public ContactZhu Jun, Song Yuqin
Peking University Cancer Hospital
Outcome results
None listed