The study is designed to evaluate the efficacy and safety of chimeric antigen receptor T-cell therapy following autologous stem cell transplantation for relapsed/refractory B-cell Non-Hodgkin's lymphoma.
Chimeric antigen receptor T (CAR-T) cell therapy has emerged as a promising approach for relapsed or refractory B-cell Non-Hodgkin's lymphoma (R/R B-NHL), with a complete response (CR) rate of about 50%. It is also considered to be a reasonable consolidation option in low or unmeasurable disease states recently. Unfortunately, 40%-70% of patients experienced relapse after CAR-T cell therapy in the long-term follow up. Autologous stem cell transplantation (ASCT) with myeloablative chemotherapy can enhance the efficiency of CAR-T cells and alleviate tumor load, leading to a lower relapse rate. As a result, CAR-T cell therapy following ASCT may be a promising method for R/R LBCL patients.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
8
Participants will undergo two separate apheresis procedures, including: G-CSF primed hematopoietic stem cell collection and peripheral blood mononuclear cell apheresis for CAR-T cell manufacturing.
Participants are designed to receive myeloablative conditioning regimen prior to infusion of a minimum 2 x 10\^6 CD34+ stem cells/kilogram.
CAR-T cells will be infused within 7 days after autologous hematopoietic stem cell infusion (2-10×10\^6 CAR-T/kg,ivgtt).
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Overall Response Rate (ORR)
Number of participants who will have achieved response after ASCT plus CAR-T cell Therapy.
Time frame: Up to 24 months
Progression-free Survival(PFS)
PFS is defined as the time from ASCT to progression, death or the last follow-up point
Time frame: Up to 24 months
Duration of Response(DOR)
To measure the duration of response to ASCT Plus CAR-T Cell Therapy over a follow-up period of 24 months
Time frame: Up to 24 months
Complete Response Rate
Number of participants who will have achieved complete response after ASCT plus CAR-T cell Therapy.
Time frame: Up to 24 months
Overall Survival(OS)
OS will be assessed from ASCT plus CAR-T cell therapy to death or last follow-up.
Time frame: Up to 24 months
Adverse events profile
Number of participants with adverse events. Frequencies of toxicities based on the NCI Common Terminology Criteria for Adverse Events (CTCAE), version 5.0 will be tabulated.
Time frame: Up to 24 months
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