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Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)

NCT07288814 · Status: NOT_YET_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 43

Last updated 2025-12-17

No results posted yet for this study

Summary

To evaluate the safety of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed or refractory peripheral T-cell lymphoma, to determine the optimal dosage of mitoxantrone hydrochloride liposome within the combination regimen, and to assess the efficacy of the combined therapy.

Conditions

  • Relapsed or Refractory Peripheral T Cell Lymphoma

Interventions

DRUG

Mitoxantrone Hydrochloride Liposome & Enlonstobart

Mitoxantrone hydrochloride liposome: ①Phase Ib：16 mg/m2、20 mg/m2 ，D1，q4w; ②Phase II：RP2D, D1，q4w, Up to 6 cycles Enlonstobart: 360mg，D1，q4w (The maintenance treatment phase is q3w), Up to 1 year

Sponsors & Collaborators

  • CSPC Ouyi Pharmaceutical Co., Ltd.

    collaborator INDUSTRY

  • Sun Yet-Sen University Cancer Center

    lead OTHER

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2025-12-08
Primary Completion
2026-12-31
Completion
2027-12-31

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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 NCT07288814 on ClinicalTrials.gov