Relapsed or Refractory Peripheral T Cell LymphomaPhase 1/2NCT07288814
Mitoxantrone Hydrochloride Liposome and Enlonstobart Combination Treatment in Patients With Relapsed or Refractory Peripheral T Cell Lymphoma (PTCL)
A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome & Enlonstobart in people with Relapsed or Refractory Peripheral T Cell Lymphoma, run by Sun Yat-Sen University Cancer Center.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Relapsed or Refractory Peripheral T Cell Lymphoma
- What is being tested?
- Mitoxantrone Hydrochloride Liposome & Enlonstobart
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 43 participants
- Where
- No sites listed yet
- Study dates
- 8 Dec 2025to 31 Dec 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
- and any other PTCL subtypes deemed by the investigator to be eligible for inclusion.
- Voluntary participation in clinical study; Fully understand and informed the study and sign the written informed consent;
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- 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:
- 1)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).
- Thyroid stimulating hormone (TSH) or free thyroxine (FT4) or free triiodothyronine (FT3) within the normal range ±10% (Note: non-autoimmune causes of abnormal TSH, FT3 and FT4 can be maintained in the normal range after replacement treatment of hypothyroidism can be enrolled).
- 9.Patients who had received previous antineoplastic therapy could not be enrolled until the toxicity of previous treatment returned to the Common Terminology Criteria for Adverse Events (CTCAE) v5.0 grade score ≤1 or the baseline level; 10.Women of childbearing potential must have a negative serum pregnancy test within 7 days before the first dose of medication; Effective contraception should be used from the time of informed consent until 6 months after the last dose of study drug.
Who cannot join
- 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;
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- 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;
- Patients with active chronic hepatitis B or active hepatitis C. Hepatitis B SurfaceAntigen (HBsAg) or hepatitis B core Antibody (HBcAb) or Hepatitis C Virus (HCV) during the screening period HCV) antibody positive patients must be further tested for Hepatitis B Virus (HBV) DNA (no more than 1000 copies /mL or 500 IU/mL) and HCV RNA (no more than the lower limit of detection of the assay), Enrollment in the trial occurred after the exclusion of patients with active hepatitis B or hepatitis C infection requiring treatment. Hepatitis B virus (HBV) carriers, medically stable hepatitis B (DNA > 1000 copies /mL or 500IU/mL) and cured hepatitis C patients are eligible for enrollment.
- 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;
- cardiac ejection fraction (LVEF) less than 50%;
- a history of myocardial infarction, unstable angina, major unstable ventricular arrhythmia or any other arrhythmia requiring treatment, a history of clinically significant pericardial disease, or electrocardiographic evidence of acute ischemic or active conduction system abnormalities within 6 months before recruitment;
- Receive live attenuated vaccine (except influenza vaccine) within 4 weeks before enrollment or during the study period;
- Previous or current concurrent cancer (except for effectively controlled non-melanoma basal cell carcinoma of the skin, breast/cervical carcinoma in situ, and other malignancies that have been effectively controlled without treatment within the previous five years);
- Those with central nervous system involvement;
- Lactating women;
- Subjects receiving systemic glucocorticoid therapy or other immunosuppressive therapy for a condition within 14 days before starting study treatment (topical, ocular, intra-articular, nasal, and inhaled glucocorticoids were allowed (minimal systemic absorption); Short-term (≤ 7 days) use of glucocorticoids was permitted for preventive treatment (e.g., contrast allergy) or for the treatment of nonautoimmune conditions (e.g., delayed hypersensitivity from contact allergens).
- Had undergone major surgery within 28 days before starting study treatment, or had undergone radiation therapy within the previous 90 days.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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）
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.
Read the 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.
- Being tested
- Mitoxantrone Hydrochloride Liposome & Enlonstobart
- Keywords
- Mitoxantrone Hydrochloride Liposome, Enlonstobart
- Medical subject headings
- Recurrence, Lymphoma, T-Cell, Peripheral
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mitoxantrone Hydrochloride Liposome & EnlonstobartDrug
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
| Study group | Role | What they receive |
|---|---|---|
| Mitoxantrone hydrochloride liposome combined with enlonstobart | Experimental | Not described Receives: Drug: Mitoxantrone Hydrochloride Liposome & Enlonstobart |
What is being measured
The primary outcome is the main question the study is designed to answer.
Phase Ib: Dose limited toxicities (DLTs)
Adverse events (AE) defined as DLT events per protocol
Measured: Cycle 1 (28 days)
Phase Ib: Recommended Phase II Dose (RP2D)
RP2D based on Phase Ib results
Measured: 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
Measured: Up to 1 years
Secondary outcomes (5)
Complete response rate (CRR)
Response is assessed according to the 2014 lugano criteria
Measured: Up to 1 years
Disease control rate (DCR)
Response is assessed according to the 2014 lugano criteria
Measured: Up to 1 years
Progression-free survival（PFS）
From the time subjects were enrolled to the time of disease progression (in any way) or death from any cause.
Measured: Up to 2 years
Overall survival (OS)
From the date of inclusion to date of death, irrespective of cause.
Measured: Up to 2 years
Adverse events(AE)
The safety of the drug was evaluated by NCI-CTC AE 5.0 standard. Hematologic and non-hematologic toxicity.
Measured: From the first day of medication to 28 days after the last dose
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2025
- Study start8 Dec 2025 (estimated)
- Primary completion31 Dec 2026 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsed or Refractory Peripheral T Cell LymphomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 43 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-Sen University Cancer Center
- Sponsor type
- University, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Responsible party
- Principal investigator, Huiqiang Huang, Sun Yat-Sen University Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07288814
- Sponsor's protocol ID
- CSPC-DED-PTCL-K08
- Status last verified
- Nov 2025
- First submitted
- 21 Nov 2025
- Last updated
- 17 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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）
- ClinicalTrials.gov ID
- NCT07288814
- Acronym / sponsor ID
- CSPC-DED-PTCL-K08
- Keywords
- Mitoxantrone Hydrochloride Liposome, Enlonstobart
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 43 participants (estimated)
- Lead sponsor
- Sun Yat-Sen University Cancer CenterUniversity, hospital or other
- Collaborators
- CSPC Ouyi Pharmaceutical Co., Ltd.
- Study start
- 8 Dec 2025 (estimated)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 17 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Mitoxantrone hydrochloride liposome combined with enlonstobart | Experimental | Drug: Mitoxantrone Hydrochloride Liposome & Enlonstobart |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- Centrally confirmed histopathological/cytologic diagnosis of PTCL with the following subtypes:
- 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;
Key exclusion criteria (24 listed)
- 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:
- Hypersensitivity reaction to any study drug or its components;
- Patients with known allergy to any component of the monoclonal antibody;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mitoxantrone Hydrochloride Liposome & EnlonstobartMitoxantrone 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 | Drug | Mitoxantrone hydrochloride liposome combined with enlonstobart |
Primary outcome
Phase Ib: Dose limited toxicities (DLTs)
Time frame: Cycle 1 (28 days)
Adverse events (AE) defined as DLT events per protocol
Phase Ib: Recommended Phase II Dose (RP2D)
Time frame: through Phase Ib study completion, an average of 3 months
RP2D based on Phase Ib results
Phase II: Objective response rate (ORR)
Time frame: Up to 1 years
Response is assessed according to the 2014 lugano criteria
5 secondary outcomes
Complete response rate (CRR)
Time frame: Up to 1 years
Disease control rate (DCR)
Time frame: Up to 1 years
Progression-free survival（PFS）
Time frame: Up to 2 years
Overall survival (OS)
Time frame: Up to 2 years
Adverse events(AE)
Time frame: From the first day of medication to 28 days after the last dose
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Mitoxantrone Hydrochloride Liposome & Enlonstobart in people with Relapsed or Refractory Peripheral T Cell Lymphoma, run by Sun Yat-Sen University Cancer Center.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 18 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 17 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Huiqiang Huang, M.D (020-87343349, huanghq@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Phase Ib: Dose limited toxicities (DLTs) (time frame: Cycle 1 (28 days)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2025.