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

NCT07724782 | Not Yet Recruiting Phase 1 DMC

• 1 other identifier: MA-PTCL-II-003
• Study Type: interventional
• Target: 33
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTCL-NOS

Outcome Measures

Primary Outcomes (2)

• Summary of DLT events (Phase Ib)

  A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design

  At the end of Cycle 1 (each cycle is 21 days)

• Overall response rate (Phase Ⅱ)

  Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox

  Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)

Secondary Outcomes (5)

• Complete response rate

  Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)

• Duration of response

  Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)

• Progression free survival

  Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)

• Overall survival

  Through study completion, an average of 3 years after EZH2+JAK1/GemOx (Day 1)

• Number of Participants With Treatment-Related Adverse Events as Assessed by CTCAE

  Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)

Study Arms (1)

Zeprumetostat + X

EXPERIMENTAL

Zeprumetostat+JAK1 inhibitor/GemoX

Drug: Zeprumetostat( an EZH2 inhibitor) + X

Interventions

Zeprumetostat( an EZH2 inhibitor) + X DRUG

Zeprumetostat( an EZH2 inhibitor) + JAK1 inhibitor or GemOx

Zeprumetostat + X

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 years or older, both males and females are eligible;
• Histologically confirmed peripheral T-cell lymphoma (PTCL) including PTCL-NOS and TFHL that has relapsed or is refractory after at least one line of systemic therapy. The definitions are as follows:
• Relapse: Patients who achieved a Complete Response (CR) in previous treatments and have new lesions at the original site or elsewhere; Refractory: Patients who did not achieve CR after adequate treatment. For nasal-type NK/T-cell lymphoma, previous treatments must have included a chemotherapy regimen containing asparaginase;
• Patients who have undergone prior hematopoietic stem cell transplantation are allowed;
• ECOG PS 0-2
• Life expectancy greater than 3 months.
• Adequate organ function
• Contraception during study
• Informed consented

You may not qualify if:

• 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);
• Known hypersensitivity to any study drugs;
• Participation in another clinical trial of an investigational drug within 4 weeks prior to the start of the study.
• Pregnant or lactation
• Active infection.
• Diseases and medical history:
• Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers
• Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.);
• Has a history of psychoactive substance abuse that cannot be discontinued
• Has any severe and/or uncontrolled disease.
• Uncontrollable autoimmune disease,
• Not able to comply to the protocol for mental or other unknown reasons

Sponsors & Collaborators

• Tianjin Medical University Cancer Institute and Hospital: lead

Study Sites (1)

Tianjin Cancer Hospital

Tianjin, Tianjin Municipality, 300060, China

Location

Central Study Contacts

Zhang huilai, MD

CONTACT

+86-18622221228; huilaizhangtz@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 7, 2026
• First Posted: July 24, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): July 30, 2030
• Study Completion (Estimated): July 30, 2031
• Last Updated: July 24, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)