Linperlisib Combined With EZH2 Inhibitor in Relapsed/Refractory Peripheral T-cell Lymphoma (PTCL)

NCT06712173 | Not Yet Recruiting Phase 1

• 1 other identifier: IIT2024029
• Study Type: interventional
• Target: 33
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Peripheral T Cell Lymphoma

Keywords

Peripheral T Cell Lymphoma; SHR2554; PI3K inhibitor linperlisib

Outcome Measures

Primary Outcomes (1)

• Maximum Tolerated Dose (MTD) of linperlisib in combination with SHR2554

  MTD will be established according to the incidence of dose-limiting toxicities (DLTs)

  28 days since the date of first dose

Secondary Outcomes (5)

• Safety of linperlisib in combination with SHR2554

  From the start of treatment until 30 days after the last treatment

• Overall response rate (ORR)

  2 years

• Complete response (CR) rate

  2 years

• Progression-free survival (PFS)

  2 years

• Overall survival (OS)

  2 years

Study Arms (1)

linperlisib combined with SHR2554

EXPERIMENTAL

Drug: linperlisib and SHR2554

Interventions

linperlisib and SHR2554 DRUG

Linperlisib doses were preset at 40mg QD and 60mg QD, while SHR2554 doses were preset at 150mg BID, 200mg BID, and 300mg BID, forming six dose groups in total.

linperlisib combined with SHR2554

Eligibility Criteria

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

You may qualify if:

• Age ≥18 years old, male or female;
• 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;
• 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;
• There must be at least one evaluable lesion/measurable lesion that meets the 2014 version of Lugano lymphoma evaluation criteria \[Evaluable lesion
• ECOG PS 0-2;
• Adequate organ function:
• Expected survival of at least 3 months;
• Fertile male and female subjects are willing to use effective contraceptive measures throughout the study period and for six months after the last dose.
• Volunteer to participate in clinical studies and sign informed consent, willing to follow and able to complete all trial procedures.

You may not qualify if:

• If a patient has any of the following conditions should not be included in this study:
• Had been treated with PI3K inhibitor or EZH2 inhibitor or EZH1/2 inhibitor before enrollment;
• Primary cutaneous T-cell lymphoma;
• History of other primary aggressive malignancies that are not in remission or in remission for no more than 3 years;
• Involvement of the central nervous system (meninges or brain parenchyma);
• People with a known allergy to any of the drugs in the study
• Participated in other drug clinical trials within 4 weeks before the study began;
• Pregnant or lactating women;
• Active infected persons, except tumor-related B symptom fever;
• Diseases and medical history:
• have multiple factors that affect oral medication (such as inability to swallow, chronic diarrhea and intestinal obstruction);
• have a history of psychotropic substance abuse and can not quit or have mental disorders;
• Subjects with any severe and/or uncontrolled medical condition;
• A history of immunodeficiency, including HIV testing positive, or other acquired or congenital immunodeficiency diseases, or a history of organ transplantation;

Sponsors & Collaborators

• Institute of Hematology & Blood Diseases Hospital, China: lead

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Lymphoma, T-Cell; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Central Study Contacts

Tingyu Wang

CONTACT

15692201678; wangtingyu@ihcams.ac.cn

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: November 25, 2024
• First Posted: December 2, 2024
• Study Start: December 1, 2024
• Primary Completion: September 30, 2025
• Study Completion: March 31, 2026
• Last Updated: December 2, 2024

Record last verified: 2024-11