Exploratory Clinical Study of SHR-0302 and SHR-2554 in Patients With Relapsed/Refractory Peripheral T Cell Lymphoma

NCT06519526 | Recruiting Phase 2 DMC

• 1 other identifier: PTCL-IIT-SHR2554-SHR0302
• Study Type: interventional
• Target: 25
• Locations: 1 country
• Sites: 1

Brief Summary

This is an open-label, prospective and exploratory clinical study to evaluate the efficacy and safety of JAK inhibitor SHR-0302 in combination with EZH2 inhibitor SHR-2554 in patients with R/R PTCL. The study plans to enroll approximately 25 patients. 6-12 patients will receive SHR-0302 monotherapy and SHR-0302+SHR-2554 combination therapy in the safety run-in phase. According to the safety observed, the investigators discuss and decide to select a dose group to explore the efficacy and safety. 13 patients may be enrolled in the expansion phase.

Conditions

Relapsed/Refractory Peripheral T Cell Lymphoma

Outcome Measures

Primary Outcomes (2)

• Incidence and severity of AEs and SAEs

  Incidence and severity of AEs and SAEs will be recorded and graded according to the CTCAE 5.0.

  The first dose until 30 days after last dose

• Objective response rate (ORR)

  Percentage of participants achieving complete response (CR) and partial response (PR) according to Lugano 2014 criteria.

  24 months

Secondary Outcomes (4)

• Disease Control Rate (DCR)

  24 months

• Duration of Response (DoR)

  24 months

• Progression-free Survival (PFS)

  24 months

• Overall Survival (OS)

  24 months

Study Arms (1)

SHR-0302 and SHR-2554 Treatment Arm

EXPERIMENTAL

SHR-2554 Oral administration, twice daily, with a 28-day continuous dosing as one cycle. SHR-0302: Oral administration, once daily,

Drug: SHR-0302; Drug: SHR-2554

Interventions

SHR-0302 DRUG

SHR-0302 will be administered orally as tablets.

SHR-0302 and SHR-2554 Treatment Arm

SHR-2554 DRUG

SHR-2554 will be administered orally as tablets.

SHR-0302 and SHR-2554 Treatment Arm

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males or females aged 18-70 years (inclusive);
• Histologically confirmed peripheral T-cell lymphoma;
• Disease status defined as relapsed or refractory after \>=1 prior systemic treatment lines;
• Have measurable lesions;
• ECOG performance status must be 0 or 1 and has not deteriorated in the past 2 weeks;
• Life expectancy ≥12 weeks;
• Adequate bone marrow reserve and organ system function reserve;
• Participants should be able and willing to comply with the study protocol requirement;

You may not qualify if:

• Received anti-tumor treatment within 28 days prior to the first dose of the study drug; received Chinese medicine treatment with anti-tumor effect within 14 days before the first dose of the study drug; received steroid hormones within 7 days prior to the first dose of study drug administration;
• Underwent major surgery within 4 weeks prior to the first dose of study treatment；
• Severe cardiovascular disease;
• Cerebrovascular accident or transient ischemic attack within 6 months prior to enrollment;
• Significant impairment of lung function;
• Active infections;
• Unexplained fever \> 38.5°C during screening period or on the first day of medication;
• Pregnant;
• Known alcohol or drug abuse;
• Subjects are currently receiving known moderately potent or potent CYP inducers/inhibitors or P-glycoprotein (P-gp) inhibitors;
• History of hypersensitivity to the investigational drug or its excipients;
• In the judgment of the investigator, objective conditions make the subject unable to complete the planned study or the subject has other factors, concomitant diseases, combined treatment or abnormal laboratory examination that may lead to the forced termination of the study.

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

Fudan University Shanghai Cancer Center

Shanghai, 200032, China

RECRUITING

MeSH Terms

Conditions

Lymphoma, T-Cell, Peripheral

Interventions

ivarmacitinib

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

Study Officials

• Rong Tao, MD

  Fudan University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rong Tao, MD

CONTACT

8621-64175590; rtao@shca.org.cn

Chuanxu Liu, MD

CONTACT

8621-64175590; liuchuanxu@shca.org.cn

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: July 19, 2024
• First Posted: July 25, 2024
• Study Start: August 12, 2024
• Primary Completion (Estimated): February 28, 2027
• Study Completion (Estimated): August 31, 2027
• Last Updated: March 24, 2026

Record last verified: 2026-03

Locations

CN (1)