Aim of this study will evaluate the Efficacy and Safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma
B-cell non-Hodgkin's lymphoma (B-NHL) is the most common hematological malignancy originating from lymphohematopoietic tissue. Lymphoma is now one of the most rapidly growing malignancies worldwide, with approximately 350,000 new cases and over 200,000 deaths worldwide each year.With the use of rituximab in combination with standard chemotherapy regimens, progression-free survival (PFS) and overall survival (OS) in B-NHL have improved significantly, yet primary resistance or relapse progression still occurs in 40%-50% of B-NHL patients.The most widely used CAR-T therapy for R/R B-NHL in clinical practice is CAR-T therapy targeting CD19, which has a complete remission rate (CR) of 40%-53% and an overall remission rate (ORR) of 52%-82%.XPO1 inhibitors are potential drugs to enhance the anti-lymphoma effect of CD19 CAR-T cells, this study will evaluate the efficacy and safety of XPO-1 inhibitors in combination with CAR-T cells in relapsed refractory B-cell non-Hodgkin's lymphoma.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
20
The First Affiliated Hospital of Soochow University
Suzhou, Jiangsu, China
Overall Response Rate (ORR)
To measure the duration of response to XPO-1 Inhibitor Plus CAR-T Cells over a follow-up period of 12 months
Time frame: up to 12 months
Duration of Response(DOR) Duration of Response(DOR)
Duration of overall response will be assessed from the first XPO-1 Inhibitor Plus CAR-T cells given to progression,death or last follow-up.
Time frame: up to 12 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 12 months
Complete Response Rate
Number of patients who achieved complete response after treatment by XPO-1 Inhibitor plus CAR-T cells.
Time frame: up to 12 months
Progression-free Survival
To measure the duration of response to XPO-1 Inhibitor plus CAR-T cells over a follow-up period of 12 months.
Time frame: up to 12 months
Overall Survival
OS will be assessed from the first XPO-1 Inhibitor plus CAR-T cells given to death or last follow-up.
Time frame: up to 12 months
Peak Plasma Concentration
the peak amplification of CART in peripheral blood.
Time frame: Measured from start of treatment until 28 days after last dose
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2-5×10\^6 CAR-T/kg,ivgtt。
Time to Peak Amplification
The time to peak amplification of CART in peripheral blood.
Time frame: Measured from start of treatment until 28 days after last dose
AUC0-28
The area under the curve (AUC0-28) obtained by plotting the number of CAR-T cells in serum against the visit time from 0 to 28 days after reinfusion.
Time frame: Measured from start of treatment until 28 days after last dose