NCT07288814

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

A Single-Arm, Open-Label Ib/II Study of Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma（PTCL）

• Status: Not Yet Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 43 (estimated)
• Sponsor: Sun Yat-Sen University Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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.

Detailed description

This is a single-arm, phase Ib/II study to investigate the safety and efficacy of mitoxantrone hydrochloride liposome combined with enlonstobart in the treatment of relapsed and refractory peripheral T-cell lymphoma, and the optimal dose of mitoxantrone hydrochloride liposome. In the dose-escalation phase, the initial dose of mitoxantrone hydrochloride liposome injection was 16mg/m2, and two dose groups of 16mg/m2, 20 mg/m2, D1, q4w were designed. Enlonstobart was administered at a fixed dose of 360mg, D1, q4w. Dose-limiting toxicity (DLT) was assessed after cycle 1. Six cycles of induction therapy were planned. After induction therapy, if the response evaluation was CR/PR, maintenance treatment with enlonstobart (360mg, D1, q3w) could be performed.

Conditions

• Relapsed or Refractory Peripheral T Cell Lymphoma

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-12-08
• Primary completion: 2026-12-31
• Completion: 2027-12-31
• First posted: 2025-12-17
• Last updated: 2025-12-17