Clinical trial · Interventional
Multi-Cohort Study of Zeprumetostat Combinations for Relapsed/Refractory PTCL
A Multi Cohort Exploratory Clinical Study of the EZH2 Inhibitor Zeprumetostat Combination Regimen in Relapsed/Refractory Peripheral T Cell Lymphoma
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| PTCL-NOS | Mature T-Cell and NK-Cell Non-Hodgkin Lymphoma | CURATED_BROADER | 0.80 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Zeprumetostat( an EZH2 inhibitor) + X | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Zeprumetostat + X
- description
- Zeprumetostat+JAK1 inhibitor/GemoX
- interventionNames
- Drug: Zeprumetostat( an EZH2 inhibitor) + X
Primary outcomes (2)
- measure
- Summary of DLT events (Phase Ib)
- timeFrame
- At the end of Cycle 1 (each cycle is 21 days)
- description
- A Phase Ib Dose-Finding Study of Zeprumetostat in Combination Using a 3+3 Design
- measure
- Overall response rate (Phase Ⅱ)
- timeFrame
- Through study completion, an average of 2 years after EZH2+JAK1/GemOx (Day 1)
- description
- Objective Response Rate (ORR) is defined as the proportion of subjects who achieve CR or PR after treatment EZH2+JAK1/GeMox
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age 18 years or older, both males and females are eligible; 2. 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; 3. Patients who have undergone prior hematopoietic stem cell transplantation are allowed; 4. ECOG PS 0-2 5. Life expectancy greater than 3 months. 6. Adequate organ function 7. Contraception during study 8. Informed consented Exclusion Criteria: 1. Prior treatment with EZH2 inhibitors or EZH1/2 inhibitors before enrollment; 2. Peripheral T-cell lymphoma of subtypes other than PTCL-NOS and TFHL; 3. History of other primary invasive malignancies that have not been in remission or have been in remission for no more than 3 years; 4. Central nervous system involvement (meningeal or parenchymal); 5. Known hypersensitivity to any study drugs; 6. Participation in another clinical trial of an investigational drug within 4 weeks prior to the start of the study. 7. Pregnant or lactation 8. Active infection. 9. Diseases and medical history: 1. Requires continuous treatment with strong or moderate CYP3A inhibitors or CYP3A inducers 2. Has multiple factors affecting oral medication administration (e.g., inability to swallow, chronic diarrhea, intestinal obstruction, etc.); 3. Has a history of psychoactive substance abuse that cannot be discontinued 4. Has any severe and/or uncontrolled disease. 10. Uncontrollable autoimmune disease, 11. Not able to comply to the protocol for mental or other unknown reasons 12. Any other condition that, in the investigator's judgment, makes the patient unsuitable for study participation.
References
Publications (0)
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