RecruitingPhase 1Phase 2NCT06966154

A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of R/R NKTCL

A Phase Ib/II Clinical Study Evaluating the Safety and Efficacy of Tislelizumab in Combination With Golidocitinib and Selinexor for the Treatment of Relapsed/Refractory Natural Killer/T-Cell Lymphoma (NKTCL)

Sponsor

Fudan University

Enrollment

68 participants

Start Date

May 26, 2025

Study Type

INTERVENTIONAL

Conditions

Natural Killer/T-cell Lymphoma Relapsed or Refractory Lymphoma Including ENKL

Summary

This open-label, multicenter Ib/II phase clinical trial investigates the safety, tolerability, and preliminary efficacy of tislezumab (anti-PD-1 monoclonal antibody), golidocitinib (JAK1/STAT3 signaling pathway inhibitor), and selinexor (selective inhibitor of nuclear export, XPO1 antagonist) in patients with relapsed/refractory extranodal natural killer/T-cell lymphoma (R/R ENKTL) progressing after ≥1 line of L-asparaginase-containing chemotherapy or chemoradiotherapy.

Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a three-drug combination — tislelizumab (immunotherapy), golidocitinib (a targeted therapy), and selinexor (another targeted drug) — for people with NK/T-cell lymphoma of the nasal type that has relapsed or stopped responding to prior chemotherapy. **You may be eligible if...** - You are willing and able to participate and have signed a consent form - You have a confirmed diagnosis of extranodal NK/T-cell lymphoma, nasal type - Your lymphoma has relapsed (came back more than 6 months after achieving remission) or is refractory (never fully responded) after asparaginase-based chemotherapy **You may NOT be eligible if...** - You have not had prior asparaginase-based treatment - You have active infections, serious heart conditions, or significant organ problems - You are pregnant or breastfeeding Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGtislezumab

Tislelizumab will be administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W).

DRUGgolidocitinib

Golidocitinib: Dose-escalating oral regimens: Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD).

DRUGSelinexor

Selinexor: Dose-escalating oral regimens: Dose A: 40 mg once weekly (QW) . Dose B: 60 mg QW for 2 consecutive weeks, followed by 1 week off.

Locations(1)

Dept of lymphoma and medical oncology, Shanghai Cancer Center

Shanghai, Shangai, China

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NCT06966154

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