RecruitingPhase 1Phase 2NCT06883526

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

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


Sponsor

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Enrollment

60 participants

Start Date

May 16, 2025

Study Type

INTERVENTIONAL

Conditions

Summary

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.


Eligibility

Min Age: 18 Years

Inclusion Criteria3

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

Exclusion Criteria3

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

Interventions

BIOLOGICALZG005 for Injection

intravenous infusion

DRUGGecacitinib Hydrochloride Tablets

Oral


Locations(1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

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NCT06883526


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