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SHR2554 Plus Liposomal Mitoxantrone as First-line Treatment for Peripheral T-cell Lymphoma (PTCL)

NCT07725705 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 44

Last updated 2026-07-24

No results posted yet for this study

Summary

This is a single-arm, multicenter, Phase Ib/IIa study designed to explore the efficacy and safety of SHR2554 in combination with liposomal mitoxantrone for the treatment of patients with treatment-naive peripheral T-cell lymphoma (PTCL). The study is divided into a Phase Ib safety lead-in phase and a Phase IIa dose expansion phase.

Conditions

  • PTCL
  • First Line Treatment

Interventions

DRUG

SHR2554 combined with Liposomal Mitoxantrone

Patients will receive 6 cycles of SHR2554 combined with liposomal mitoxantrone as induction therapy. All patients who achieve a complete response (CR) after induction therapy are eligible for transplantation. Patients achieving CR or partial response (PR), as well as those post-transplantation, may receive SHR2554 maintenance therapy in 28-day cycles. Maintenance therapy will continue until disease progression or other reasons for discontinuation. The maximum duration of SHR2554 administration in the maintenance phase will not exceed 24 months.

Sponsors & Collaborators

  • Institute of Hematology & Blood Diseases Hospital, China

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2028-08-01
Completion
2030-03-01

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07725705 on ClinicalTrials.gov