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

Phase 1

Not yet recruiting

• Conditions: Lymphoma
• Interventions: Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets

• Registration Number: NCT06883526
• Lead Sponsor: Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-03-13
• Study First Submitted QC: 2025-03-13
• Study First Posted: 2025-03-19
• Status Verified: 2025-04
• Last Update Submitted: 2025-04-14
• Last Update Posted: 2025-04-18
• Study Start: 2025-05
• Primary Completion: 2027-04
• Study Completion: 2027-05

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SEQUENTIAL

Arm && Interventions

Group	Intervention	Description
Part 1: Plan A	ZG005 for Injection	ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously until the end of treatment）
Part 1: Plan B	Gecacitinib Hydrochloride Tablets	ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21）
Part 1: Plan A	Gecacitinib Hydrochloride Tablets	ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously until the end of treatment）
Part 1: Plan B	ZG005 for Injection	ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21）

Primary Outcome Measures

Name	Time	Method
Objective response rate (ORR)	Up to 2 years

Secondary Outcome Measures

Name	Time	Method
Immunogenicity	Up to 2 years	Incidence of antidrug antibodies (ADA)

Trial Locations

Locations (1)

The First Affiliated Hospital, Zhejiang University School of Medicine; 🇨🇳 Hangzhou, Zhejiang, China