Efficacy and Safety of BV With Tislelizumab for the Treatment of CD30+ Relapsed/Refractory NK/T-cell Lymphoma

PHASE2UnknownINTERVENTIONAL
Enrollment

40

Participants

Timeline

Start Date

June 1, 2022

Primary Completion Date

June 1, 2024

Study Completion Date

December 31, 2024

Conditions
NK/T Cell Lymphoma Nos
Interventions
DRUG

Brentuximab Vedotin in Combination with Tislelizumab

Brentuximab vedotin will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a dose of 1.8 mg/kg. Tislelizumab will be administered after diluted with 100 ml normal saline as an IV infusion over approximately 30 minutes on Day 1 of each 21-day cycle at a fixed dose of 200 mg. The rationale of fixed dose of Tislelizumab is according to the drug description, which is based on previous I/II phase clinical trial results of Tislelizumab. The time interval between administration of tislelizumab and brentuximab vedotin should be not less than 2 hours, and thereafter, the dosing cycle of tislelizumab is synchronized with that of brentuximab vedotin.

Sponsors

Collaborators (2)

All Listed Sponsors
collaborator

Takeda

INDUSTRY

collaborator

BeiGene

INDUSTRY

lead

Shanghai Zhongshan Hospital

OTHER