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

NCT06883526 | Recruiting Phase 1

• 1 other identifier: ZG005-JAK-002
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

PART 1:

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

Conditions

Lymphoma

Outcome Measures

Primary Outcomes (1)

• Objective response rate (ORR)

  Up to 2 years

Secondary Outcomes (1)

• Immunogenicity

  Up to 2 years

Study Arms (2)

Part 1: Plan A

EXPERIMENTAL

ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously until the end of treatment）

Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets

Part 1: Plan B

EXPERIMENTAL

ZG005（20mg/kg Q3W）+Gecacitinib（Gecacitinib is administered continuously from CnD1 to D14, and discontinued from CnD15 to D21）

Biological: ZG005 for Injection; Drug: Gecacitinib Hydrochloride Tablets

Interventions

ZG005 for Injection BIOLOGICAL

intravenous infusion

Also known as: ZG005

Part 1: Plan A; Part 1: Plan B

Gecacitinib Hydrochloride Tablets DRUG

Oral

Also known as: Gecacitinib

Part 1: Plan A; Part 1: Plan B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Suzhou Zelgen Biopharmaceuticals Co.,Ltd: lead

Study Sites (1)

The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

RECRUITING

MeSH Terms

Conditions

Lymphoma

Interventions

Injections

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Drug Administration Routes; Drug Therapy; Therapeutics

Study Officials

• Jason Wu

  Suzhou Zelgen Biopharmaceuticals Co.,Ltd

  STUDY CHAIR

Central Study Contacts

Shuangyu Jia

CONTACT

+86-0512-57018310; jiasy@zelgen.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 13, 2025
• First Posted: March 19, 2025
• Study Start: May 16, 2025
• Primary Completion (Estimated): April 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: January 5, 2026

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)