B cell Lymphoma
Conditions
Interventions
CAR2219 CAR-T cells group:Using the traditional 3+3 dose escalation method, the initial dose of CAR2219 CAR-T cells was 5×10^5/kg, and the dose was planned to increase to 1×10^6/kg and 2×10^6/kg.
Sponsors
The First Medical Center of PLA General Hospital, China
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. I am willing and able to follow the planned visit, study treatment, laboratory tests and other trial procedures after I have signed the informed consent; 2. Patients with relapsed/refractory CD19+CD22+ B-cell lymphoma confirmed cytologically or histologically according to the WHO 2022 criteria: 2.1 The expression of CD19 and/or CD22 antigen in lymphoma cells was confirmed by immunophenotyping or histopathological immunohistochemical examination. 2.2 B-cell lymphoma includes: aggressive B-cell lymphoma (LBCL, BL, MCL), indolent B-cell lymphoma (CLL/SLL, FL, MZL, LPL, HCL); 2.3 Relapsed/refractory B-cell lymphoma: patients with aggressive lymphoma received at least first-line and second-line drug treatment and had stable disease =70g/L (transfusible); 7. Liver and kidney function, cardiopulmonary function meet the following requirements: (1) creatinine =50%; (3) Oxygen saturation >90%; (4) Total bilirubin <=1.5×ULN, ALT and AST<=2.5×ULN; 8. Participants agreed to use contraception from the time of informed consent until 1 year after CAR-T cell infusion.
Exclusion criteria
Exclusion criteria: 1. Severe heart failure with left ventricular ejection fraction <50%; 2. A history of severe lung function impairment; 3. Combined with other advanced malignant tumors; 4. Complicated with severe infection that could not be effectively controlled; 5. Severe autoimmune disease or congenital immune deficiency; 6. Active hepatitis (hepatitis B virus DNA [HBV-DNA] or hepatitis C virus RNA [HCV-RNA] test results above the lower limit of detection); 7. Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), or syphilis infection; 8. History of severe allergy to biological products (including antibiotics); 9. Allogeneic hematopoietic stem cell transplantation (allo-HSCT) patients with acute graft-versus-host reaction (GVHD) one month after immunosuppressant withdrawal; 10. Patients with other serious physical or mental illnesses or laboratory abnormalities that could increase the risk of participating in the study or interfere with the results of the study, and those who were deemed by the investigator to be unsuitable for participation in the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The incidence of adverse events; | — |
Secondary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR);Complete response rate (CRR);Duration of response (DOR);Progression free survival (PFS);Overall survival (OS); | — |
Countries
China
Contacts
Public ContactLi Meng
Senior Department of Hematology, PLA General Hospital Department of Hematology, the First Medical Center of PLA General Hospital
Outcome results
None listed