Clinical trial · Interventional
Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)
A Single Arm, Open Label, Single-center Dose-exploratory Clinical Study of Linperlisib in Combination With EZH2 Inhibitor SHR2554 in the Treatment of Relapsed/Refractory Peripheral T-cell Lymphoma
NCT06712173CI-TRIAL-00083169not yet recruitingPhase 1ClinicalTrials.gov clinicaltrialsProvenance
- 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 Phase I, multicenter, non-randomized, open-label, dose-exploratory clinical study to evaluate the safety and tolerability of linperlisib combined with SHR2554 in the treatment of R/R PTCL, and to preliminary observe the antitumor efficacy of the combination of the two drugs.
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 |
|---|---|---|---|
| Peripheral T Cell Lymphoma | Peripheral T-Cell Lymphoma, Not Otherwise Specified | ONTOLOGY_EXACT | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| linperlisib and SHR2554 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- linperlisib combined with SHR2554
- interventionNames
- Drug: linperlisib and SHR2554
Primary outcomes (1)
- measure
- Maximum Tolerated Dose (MTD) of linperlisib in combination with SHR2554
- timeFrame
- 28 days since the date of first dose
- description
- MTD will be established according to the incidence of dose-limiting toxicities (DLTs)
Secondary outcomes (5)
- measure
- Safety of linperlisib in combination with SHR2554
- timeFrame
- From the start of treatment until 30 days after the last treatment
- description
- The incidence and severity of treatment-emergent AEs will be collected and the safety and tolerability of linperlisib in combination with SHR2554 will be assessed.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age ≥18 years old, male or female; 2. Pathologically confirmed PTCL, including systemic anaplastic large cell lymphoma (ALCL), peripheral T cell lymphoma non-specific type (PTCL NOS), lymph node T-follicular helper cell lymphoma (nTFHL) \[including nTFHL angioimmunoblastic type (NTFHL-AI), nTFHL follicular type (NTFHL-F) and nTFHL non-specific name (NTFHL-NOS)\], enteropathy-associated T-cell lymphoma and hepato-splenic T-cell lymphoma; 3. Have received at least one previous systemic therapy, ALCL patients must have received CD30-targeted therapy; Patients were allowed to have received hematopoietic stem cell transplantation; 4. There must be at least one evaluable lesion/measurable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria \[Evaluable lesion 5. ECOG PS 0-2; 6. Adequate organ function: 7. Expected survival of at least 3 months; 8. Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose. 9. Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures. Exclusion Criteria: If a patient has any of the following conditions should not be included in this study: 1. Had been treated with PI3K inhibitor or EZH2 inhibitor or EZH1/2 inhibitor before enrollment; 2. Primary cutaneous T-cell lymphoma; 3. History of other primary aggressive malignancies that are not in remission or in remission for no more than 3 years; 4. Involvement of the central nervous system (meninges or brain parenchyma); 5. People with a known allergy to any of the drugs in the study 6. Participated in other drug clinical trials within 4 weeks before the study began; 7. Pregnant or lactating women; 8. Active infected persons, except tumor-related B symptom fever; 9. Diseases and medical history: 1. have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction); 2. have a history of psychotropic substance abuse and can not quit or have mental disorders; 3. Subjects with any severe and/or uncontrolled medical condition; 10. A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation; 11. Other situations deemed unsuitable for inclusion in the study by the researcher.
References
Publications (0)
Data not yet available
No reference posted for this study.