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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

NCT06966154 · Status: RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 68

Last updated 2025-05-30

No results posted yet for this study

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.

Conditions

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

Interventions

DRUG

tislezumab

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

DRUG

golidocitinib

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

DRUG

Selinexor

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.

Sponsors & Collaborators

  • Fudan University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-05-26
Primary Completion
2027-05-30
Completion
2028-05-30

Countries

  • China

Study Locations

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Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06966154 on ClinicalTrials.gov