Multi-Cohort Study of Zeprumetostat Combinations for Relapsed/Refractory PTCL

ConditionPTCL-NOS
Trial statusNot yet recruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorTianjin Medical University Cancer Institute and Hospital

About this trial

This is a single-arm, multi-cohort, multicenter, phase Ib/IIa clinical study designed to evaluate the safety and efficacy of Zeprumetostat (an EZH2 inhibitor) in combination with different therapeutic agents/regimens - specifically, the JAK1 inhibitor golidocitinib and the GemOx chemotherapy regimen (gemcitabine plus oxaliplatin) - in patients with relapsed or refractory peripheral T-cell lymphoma, not otherwise specified (PTCL-NOS) and T-follicular helper cell lymphoma (TFHL). The trial comprises a phase Ib dose-escalation phase and a phase IIa dose-expansion phase. Two combination cohorts are established: Cohort A (zemitostatin + golidocitinib) and Cohort B (zemitostatin + GemOx). Subjects will be randomly assigned to either Cohort A or Cohort B.

Eligibility criteria

Qualifiers

Age 18 years or older, both males and females are eligible;

Patients who have undergone prior hematopoietic stem cell transplantation are allowed;

ECOG PS 0-2

Life expectancy greater than 3 months.

Disqualifiers

Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment;

Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL;

History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years;

Central nervous system involvement (meningeal or parenchymal);

Trial design

Treatments tested in this trial

  • Zeprumetostat( an EZH2 inhibitor) + X

Treatment groups

33 Participants
are divided into 1 treatment group