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

Soochow University

Status: Unknown

Conditions: Relapsed Non Hodgkin Lymphoma; Refractory Non-Hodgkin Lymphoma

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT04923789

2020173

Details and patient eligibility

About

This is a single center, prospective cohort study to to evaluate the efficacy and safety of autologous hematopoietic stem cell transplantation(ASCT) bridging chimeric antigen receptor T (CART) cell therapy in the treatment of relapsed/refractory B-cell non-Hodgkin's lymphoma.

Full description

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Histologically confirmed B-NHL with extrinsic involvement.
2. Age ≥ 18 years and ≤ 65 years.
3. Measurable disease of at least 15mm(node)/10mm（extranodal）
4. 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.
5. Receive standard autologous hematopoietic stem cell transplantation with CD34+ cells ≥2*10^6/kg.
6. Estimated survival time ≥3 months

Exclusion criteria

1. Having received allogeneic hematopoietic stem cell transplantation previously;
2. HIV-positive;
3. Active hepatitis B or C infection;
4. 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.
5. Patients with cardiac insufficiency:ejection fraction (EF) < 30%, NYHA standard, grade II or above
6. 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)
7. Female patients who are pregnant, preparing to become pregnant or lactating.
8. The investigator believes that there are other factors that are not suitable for inclusion or affect subjects' participation or completion of the study.

Trial design

60 participants in 2 patient groups

ASCT Without CART

Description:

Patients who undergone ASCT successfully and did not receive CART cell infusion.

ASCT Bridging CART

Description:

Patients who undergone ASCT and received CART cell infusion sequently within 1 month. Patients with disease recurrence or progression prior to the infusion of CART cells will be excluded.