CD19 CAR-T Expressing IL-7 and CCL19 Combined With Anti-PD1 in RR-DLBCL
Diffuse Large B-cell Lymphoma
About this trial
This is an interventional treatment trial for Diffuse Large B-cell Lymphoma
Eligibility Criteria
Inclusion Criteria: Age ≥ 18, upper limit 75, male or female; ECOG score 0-3; Histologically confirmed diffuse large B-cell lymphoma (DLBCL) [diagnostic criteria according to WHO 2008]; CD19 positive (immunohistochemistry or flow cytometry). DLBCL refractory or relapse is defined as: complete remission is not achieved after 2-line treatment; let What disease progress occurs during treatment, or the disease stability time is equal to or less than 6 months; Or autologous hematopoietic stem Disease progression or recurrence within 12 months after cell transplantation; Previous treatment for patients with diffuse large B cell lymphoma must include rituximab (CD20 monoclonal antibody) and anthracyclines; At least one measurable lesion is required, and any lymph node lesion with a length greater than 1.5cm or extranodal lesion is required If any length diameter is greater than 1.0 cm, the lesions on PET-CT scan have uptake (SUV is larger than liver blood pool); Absolute value of peripheral blood neutrophils ≥ 1000/ μ l. Platelets ≥ 45000/ μ l Heart, liver and kidney functions: creatinine < 1.5mg/dL; ALT/AST Less than 2.5 times of normal upper limit; Total bilirubin < 1.5mg/dL; Cardiac ejection fraction (EF) ≥ 50%; Have sufficient understanding and voluntarily sign the informed consent form; People with fertility must be willing to use contraceptive methods; According to the judgment of the researcher, the expected survival period is at least 4 months; Willing to follow the visit schedule, administration plan, laboratory inspection and other test steps. Exclusion Criteria: Have a history of other tumors; Autologous hematopoietic stem cell transplantation was performed within 6 weeks; Any target CAR-T treatment was performed within 3 months before this CAR-T treatment; Previously used any commercially available PD-1 monoclonal antibody; Cytotoxic drugs, glucocorticoids and other targeted drugs were received within 2 weeks before cell collection; Active autoimmune diseases; Uncontrollable active bacterial and fungal infections; HIV infection and syphilis infection; Active hepatitis B or hepatitis C: hepatitis B: HBV-DNA ≥ 1000 IU/mL; Hepatitis C: HCV RNA is positive and liver function is abnormal. Known central nervous system lymphoma.
Sites / Locations
- The Second Affiliated Hospital of Zhejiang University, Ningbo First HospitalRecruiting
- Ningbo First HospitalRecruiting
Arms of the Study
Arm 1
Experimental
CAR-T combined with anti-PD1 treatment group
CD19-7×19 CAR-T combined with Tislelizumab