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

Sponsor
Fudan University
Study ID
NCT06966154
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

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

Eligibility Criteria

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

Interventions

  • tislezumab — DRUG
    Tislelizumab will be administered intravenously at a fixed dose of 200 mg every 3 weeks (Q3W).
  • golidocitinib — DRUG
    Golidocitinib: Dose-escalating oral regimens: Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD).
  • Selinexor — DRUG
    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.

Study Details

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.

Key Dates

Start date
May 26, 2025
Status verified
May 2025
Primary completion
May 30, 2027
Completion
May 30, 2028

Study Design

Enrollment
68 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: tislezumab plus golidocitinib and selinexor
    Patients will receive Tislelizumab: Fixed intravenous dose of 200 mg every 3 weeks (Q3W). Golidocitinib: Dose-escalating oral regimens: Dose level A: 150 mg every other day (QOD). Dose level B: 150 mg once daily (QD). 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. Safety monitoring will be performed throughout each 3-week cycle, with dose escalation contingent on safety/tolerability assessments.

Primary Outcome Measure

RP2D of golidocitinib in combination with selinexor [ Time Frame: 4 weeks after the initiation of combination treatment ]

Central Contacts