A Study of Selinexor in Combination With Temozolomide and Anti-PD-1 Antibody in Patients With Relapsed/Refractory Primary Central Nervous System Lymphoma

This study is a prospective, single-arm, open label, Phase Ib/II clinical study to evaluate the safety and efficacy of selinexor in combination with temozolomide and anti-PD-1 monoclonal antibody in patients with relapsed/refractory primary central nervous system lymphoma(PCNSL). Phase Ib used a "3+3" dose-climbing design to confirm the safety, maximum-tolerated dose (MTD,if any) and recommended phaseII dose (RP2D) of selinexor in combination with fixed dose of temozolomide and anti-PD-1 monoclonal antibody for 6 cycles. Phase II was a comprehensive evaluation of efficacy and safety. Subjects

Trial Details

NCT ID
NCT06556199
Phase
PHASE1 / PHASE2
Sponsor
Second Affiliated Hospital, Zhejiang University, School of Medicine
Status
RECRUITING
Cancer Type
Lymphoma
Interventions
  • Selinexor
  • Temozolomide
  • Anti-PD-1 monoclonal antibody
Locations (sample)
  • Hanzhou, Zhejiang, China

Key Eligibility Criteria

  • Aged between 18 and 75 (inclusive).
  • Participants must be able to understand and be willing to sign a written informed consent document.
  • Eastern Cooperative Oncology Group performance status 0 to 3.
  • Life expectancy of ≥ 3 months (in the opinion of the investigator).

For full eligibility, visit ClinicalTrials.gov.

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