Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05322330 | Clinical Study of XPO-1 Inhibitors Plus CAR-T Cells in Relapsed Refractory B-cell Non-Hodgkin's Lymphoma | PHASE2 | COMPLETED | 20 | — | — | Feb 10, 2022 | Feb 10, 2024 | Jun 2, 2026 | 1 | China |
To measure the duration of response to XPO-1 Inhibitor Plus CAR-T Cells over a follow-up period of 12 months
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.
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.
| Arm | Type | Description |
|---|---|---|
| XPO-1 Inhibitor+CAR-T Cells | EXPERIMENTAL | XPO-1 Inhibitor plus CAR-T Cells |
| Name | Type | Description |
|---|---|---|
| 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。 |
Inclusion Criteria: 1. Age ≥ 18 years. 2. Pathological immunohistochemistry or flow cytometry confirmed that R/ R B-cell Non-Hodgkin's Lymphoma with measurable (diameter greater than 1.5cm) lesions meets any of the following conditions: 1\> After 4 courses of standard first-line therapy or 2 course...