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

NCT07288814 | Not Yet Recruiting Phase 1

• 1 other identifier: CSPC-DED-PTCL-K08
• Study Type: interventional
• Target: 43
• Locations: 0 countries
• Sites: N/A

Brief 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

Keywords

Mitoxantrone Hydrochloride Liposome; Enlonstobart

Outcome Measures

Primary Outcomes (3)

• Phase Ib: Dose limited toxicities (DLTs)

  Adverse events (AE) defined as DLT events per protocol

  Cycle 1 (28 days)

• Phase Ib: Recommended Phase II Dose (RP2D)

  RP2D based on Phase Ib results

  through Phase Ib study completion, an average of 3 months

• Phase II: Objective response rate (ORR)

  Response is assessed according to the 2014 lugano criteria

  Up to 1 years

Secondary Outcomes (5)

• Complete response rate (CRR)

  Up to 1 years

• Disease control rate (DCR)

  Up to 1 years

• Progression-free survival（PFS）

  Up to 2 years

• Overall survival (OS)

  Up to 2 years

• Adverse events(AE)

  From the first day of medication to 28 days after the last dose

Study Arms (1)

Mitoxantrone hydrochloride liposome combined with enlonstobart

EXPERIMENTAL

Drug: Mitoxantrone Hydrochloride Liposome & Enlonstobart

Interventions

Mitoxantrone Hydrochloride Liposome & Enlonstobart DRUG

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

Mitoxantrone hydrochloride liposome combined with enlonstobart

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:
• Peripheral T-cell lymphoma, not otherwise specified (PTCL, NOS);
• Systemic anaplastic large cell lymphoma (ALK+ and ALK-);
• Follicular helper T (TFH) cell lymphoma of lymph nodes, including angioimmunoblastic, follicular, NOS;
• Voluntary participation in clinical study; Fully understand and informed the study and sign the written informed consent;
• Age ≥18 years old, and ≤ 75 years old, regardless of gender;
• Met the criteria of relapsed/refractory lymphoma: Relapsed lymphoma was defined as relapsed lymphoma more than 6 months after achieving complete remission (CR) after initial chemotherapy. Refractory lymphoma was defined as any of the following criteria: 1) tumor shrinkage \< 50% or disease progression after at least 4 courses of standard chemotherapy; 2) achieved CR with standard chemotherapy, but relapsed within half a year;
• ECOG performance status score: 0-2;
• Expected survival time ≥3 months;
• There must be at least one measurable or evaluable lesion that meets the Lugano 2014 criteria for lymphoma:
• )Measurable lesion: Nodal lesions with major diameter greater than 1.5cm and minor diameter greater than 1.0cm as assessed by PET/CT or Computed Tomography (CT) and/or Magnetic Resonance Imaging (MRI); Or the length of extranodal lesions \>1.0cm; 2)Evaluable lesions: PET-CT showed increased uptake in lymph nodes or extranodal regions (higher than liver) and imaging features consistent with lymphoma; 8.Have adequate organ and bone marrow function, defined as follows:
• Blood routine: absolute neutrophil count (ANC) ≥ 1.5×109/L(≥1.0×109/L in patients with bone marrow involvement); platelet count (PLT) ≥ 75×109/L(≥50×109/L in patients with bone marrow involvement), hemoglobin (HGB) ≥ 8.0 g/dL; The patients had not received granulocyte growth factor, platelet transfusion, or red blood cell transfusion within 14 days before the examination;
• Liver function: serum total bilirubin (TBIL) ≤1.5× upper limit of normal value (ULN, liver invasion ≤3.0×ULN); alanine aminotransferase (ALT) and aspartate transferase (AST) ≤2.5×ULN (liver invasion ≤5.0×ULN);
• Renal function: serum creatinine (Cr) ≤1.5×ULN.
• Coagulation function: International Normalized Ratio (INR) ≤1.5 × ULN; Prothrombin Time (PT), Activated PartialThromboplastin Time (APTT) ≤1.5×ULN (unless the subject is receiving anticoagulant therapy, And PT and APTT at screening were within the expected range for anticoagulant therapy).

You may not qualify if:

• Patients with hemophagocytic lymphohistiocytosis;
• Patients with active infection or with obvious B symptoms and high fever should be excluded according to the comprehensive judgment of the investigators;
• The subject's previous history of antineoplastic therapy meets one of the following conditions:
• Failure to achieve CR or PR after previous treatment with mitoxantrone or mitoxantrone liposome, or relapse within 6 months after treatment;
• Prior treatment with anthracyclines or anthraquinones and cumulative dose of doxorubicin \> 550 mg/m2 (liposomal doxorubicin \> 2000 mg/m2, epirubicin \> 1000 mg/m2, pirarubicin \> 1000 mg/m2, mitoxantrone \> 160 mg/m2);
• Received anti-tumor treatment (including chemotherapy, targeted therapy, traditional Chinese medicine with anti-tumor activity, etc.) or participated in other clinical trials and received clinical trial drugs within 4 weeks or 5 half-lives (whichever came first) before the first use of the study drug;
• patients who received autologous hematopoietic stem-cell transplantation or allogeneic hematopoietic stem-cell transplantation within 100 days of the first dose of treatment;
• Hypersensitivity reaction to any study drug or its components;
• Patients with known allergy to any component of the monoclonal antibody;
• Patients with a known history of Human Immunodeficiency Virus (HIV) infection and/or acquired immunodeficiency syndrome;
• Cardiac function and disease is one of the following:
• long QTc syndrome or QTc interval \>480 ms;
• complete left bundle branch block, degree II or III atrioventricular block;
• severe, uncontrolled arrhythmia requiring medical treatment;
• New York College of Cardiology grade ≥ III;

Sponsors & Collaborators

• Sun Yat-Sen University Cancer Center: lead
• CSPC Ouyi Pharmaceutical Co., Ltd.: collaborator

MeSH Terms

Conditions

Recurrence; Lymphoma, T-Cell, Peripheral

Condition Hierarchy (Ancestors)

Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; 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

Huiqiang Huang, M.D

CONTACT

020-87343349; huanghq@sysucc.org.cn

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Head of Medical Oncology, Principal Investigator, Clinical Professor

Study Record Dates

• First Submitted: November 21, 2025
• First Posted: December 17, 2025
• Study Start: December 8, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): December 31, 2027
• Last Updated: December 17, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share