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Phase 1, Phase 2Not yet recruitingPriority 3 · Moderate priorityNCT07288814

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

ClinicalTrials.gov

Plain-language summary

This Phase 1, Phase 2 trial is evaluating Mitoxantrone Hydrochloride Liposome & Enlonstobart as a treatment for people newly diagnosed with T-cell lymphoma. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join (key eligibility)

  • Age 18 Years to 75 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

Final eligibility is determined by the trial team. This list is a starting point only.

What's being tested

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

Drugs / treatments
Mitoxantrone Hydrochloride Liposome & Enlonstobart
Treatment length
Ask the trial team for details
Visit frequency
Ask the trial team for details

At a glance

Phase
Phase 1, Phase 2
Status
Not yet recruiting
Design
Non-randomized, open-label
Enrollment target
43 patients
Primary endpoint
Phase Ib: Dose limited toxicities (DLTs); Phase Ib: Recommended Phase II Dose (RP2D); Phase II: Objective response rate (ORR)
Ages
18 Years to 75 Years
Start date
2025-12-08
Est. completion
2027-12-31

Locations

0 US sites · 0 total

No US sites currently listed.

Contact

Sponsor
Sun Yat-Sen University Cancer Center (OTHER)
Contact
Huiqiang Huang, M.D | huanghq@sysucc.org.cn | 020-87343349

Tags

All T-cell lymphomasNewly diagnosedRelapsed/Refractory
TrialCompass — Clinical Trial Summary

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

NCT07288814

Phase: Phase 1, Phase 2 | Status: Not yet recruiting | Priority: Medium

Plain-language summary

This Phase 1, Phase 2 trial is evaluating Mitoxantrone Hydrochloride Liposome & Enlonstobart as a treatment for people newly diagnosed with T-cell lymphoma. The study starts with lower doses to find the safest effective dose before testing in more people. This trial does not currently list US sites.

Who can join

  • Age 18 Years to 75 Years years
  • Newly diagnosed, not yet treated
  • Must be well enough for treatment (adequate performance status)
  • May require specific number of prior treatments

What's being tested

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

Drugs / treatments: Mitoxantrone Hydrochloride Liposome & Enlonstobart

Treatment length: Ask the trial team for details

Visit frequency: Ask the trial team for details

Trial design

Non-randomized, open-label

Enrollment target: 43 patients

Primary endpoint: Phase Ib: Dose limited toxicities (DLTs); Phase Ib: Recommended Phase II Dose (RP2D); Phase II: Objective response rate (ORR)

Ages: 18 Years to 75 Years

Start date: 2025-12-08 | Est. completion: 2027-12-31

Locations

0 US sites · 0 total

Contact

Huiqiang Huang, M.D | huanghq@sysucc.org.cn | 020-87343349

Sponsor: Sun Yat-Sen University Cancer Center (OTHER)

Tags

All T-cell lymphomas · Newly diagnosed · Relapsed/Refractory

View on ClinicalTrials.gov

https://clinicaltrials.gov/study/NCT07288814

Prepared using TrialCompass (trialcompass.com) on June 19, 2026. For informational purposes only. Always discuss with your healthcare team.
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Data sourced from ClinicalTrials.gov.

For informational purposes only. Not medical advice — always consult your healthcare team.

Built with care for the rare cancer community.

Data last updated: June 2026

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