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Recruiting

NCT Number: NCT06883526

Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma

PART 1:

1. To explore the safety of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma. 2. To determine the recommended Phase II dosing regimen for relapsed or refractory lymphoma.

PART 2:

To evaluate the efficacy of ZG005 in combination with Gecacitinib in patients with relapsed or refractory lymphoma.

Recruiting

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Key information

Conditions

Lymphoma Hemic and Lymphatic Diseases Immune System Diseases Immunoproliferative Disorders Lymphatic Diseases Lymphoproliferative Disorders Neoplasms Neoplasms by Histologic Type

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Location status: Recruiting

Location contact

Jie Jin

CONTACT

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Fully understand this study and voluntarily sign the ICF；
  • Age ≥18 at ICF signing, regardless of gender；
  • Histologically confirmed relapsed or refractory lymphoma.

Exclusion criteria

  • Lymphoma with known CNS involvement；
  • Severe cardiovascular/cerebrovascular diseases.
  • Any other reason deeming the participant unsuitable for the study, as judged by the investigator.

Treatment and study plan

ZG005 for Injection

Biological

intravenous infusion

Other names: ZG005

Gecacitinib Hydrochloride Tablets

Drug

Oral

Other names: Gecacitinib

Primary outcomes

  1. Objective response rate (ORR)

    Time frame: Up to 2 years

Secondary outcomes

  1. Immunogenicity

    Time frame: Up to 2 years

    Incidence of antidrug antibodies (ADA)

Study contacts

Contact information is provided by the study sponsor or research team.

Shuangyu Jia

CONTACT

[email protected]

+86-0512-57018310

Sponsors and collaborators

Lead sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Industry

Registry information

Official study title

A Multicenter, Open-Label, Dose-Escalation and Dose-Expansion Phase I/II Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Mar 19, 2025
Registry last updated
Jan 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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