A Study of ASCT Bridging CART Cell Therapy in Relapsed/Refractory B-cell Lymphoma

High-dose chemotherapy followed by autologous hematopoietic stem cell transplantation(ASCT) is still the standard salvage treatment for relapsed/refractory B-cell non-Hodgkin's lymphoma (R/R B-NHL). However, its overall survival (OS) and event-free survival (EFS) of 3 years and above are less than 50%. Chimeric antigen receptor T (CART) cell therapy has shown great efficacy in treating B-NHL in recent years. Preclinical studies have indicated that the infusion of hematopoietic stem cells could promote the amplification and function of adoptive metastatic anti-tumor CD8+T cells, providing a certain theoretical basis for ASCT combined with CART cell therapy. In order to evaluate the efficacy and safety of ASCT bridging CART cell therapy in treating R/R B-NHL, we conduct this single center, prospective cohort study.

Inclusion criteria

• Histologically confirmed B-NHL with extrinsic involvement.
• Age ≥ 18 years and ≤ 65 years.
• Measurable disease of at least 15mm(node)/10mm（extranodal）
• Meet any of the following conditions :1. After 4 courses of standard first-line treatment or 2 courses of treatment with more than two lines, the lesions decreased by less than 50%;2 B-NHL with disease progression after first-line or induction treatment;3. Relapsed B-NHL within 12 months after ASCT;4. After standard chemotherapy or hematopoietic stem cell transplantation, the size of any new lesions or the previously involved site which had achieved complete remission increased by 50% or more.
• Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2*10^6/kg.
• Estimated survival time ≥3 months

Exclusion criteria

• Having received allogeneic hematopoietic stem cell transplantation previously;
• HIV-positive;
• Active hepatitis B or C infection;
• Previous history of other malignant tumors. Excluded: Patients who had cured basal or squamous cell carcinoma of the skin and carcinoma in situ of the cervix at any time prior to the study; Patients with disease-free survival ≥5 years who had been cured by surgery only without further treatment for the other tumors listed above can be included in the study.
• Patients with cardiac insufficiency:ejection fraction (EF) < 30%, NYHA standard, grade II or above
• Patients with liver and renal insufficiency: Serum Direct Bilirubin (SB) ≥2mg/ dL (34.2μmol/L), Aspartate Aminotransferase(AST) > 2.5 times the up, Serum Creatinine (SCR) > 2.5mg/ dL (221μmol/L)
• Female patients who are pregnant, preparing to become pregnant or lactating.
• The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.