Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma

Sponsor: The First Affiliated Hospital of Soochow University
Study ID: NCT05322330
Phase: PHASE2
Status: Completed

Conditions

Relapsed/Refractory B-cell Non-Hodgkin's Lymphoma

Eligibility Criteria

Sex: ALL
Age: 18 Years - N/A
Healthy Volunteers: Not accepted

Interventions

Selinexor — DRUG
40-60mg QW,w-3～d-3,PO
Flu — DRUG
25-30 mg/m2，d-5 ～d-3，qd，ivgtt
CTX — DRUG
250-500 mg/m2，d-5 ～d-3，qd，ivgtt
CAR-T — DRUG
2-5×10\^6 CAR-T/kg，ivgtt。

Study Details

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

Key Dates

Start date: Feb 10, 2022
Status verified: Mar 2022
Primary completion: Feb 10, 2024
Completion: Feb 10, 2024

Study Design

Enrollment: 20 participants (actual)
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Arms

Experimental: XPO-1 Inhibitor+CAR-T Cells
XPO-1 Inhibitor plus CAR-T Cells

Primary Outcome Measure

Overall Response Rate (ORR) [ Time Frame: up to 12 months ]