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

NCT ID: NCT06883526

Last Updated: 2026-01-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1/PHASE2

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-05-16

Study Completion Date

2027-05-31

Brief Summary

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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

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Conditions

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Lymphoma

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SEQUENTIAL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Part 1: Plan A

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

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

intravenous infusion

Gecacitinib Hydrochloride Tablets

Intervention Type DRUG

Oral

Part 1: Plan B

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

Group Type EXPERIMENTAL

ZG005 for Injection

Intervention Type BIOLOGICAL

intravenous infusion

Gecacitinib Hydrochloride Tablets

Intervention Type DRUG

Oral

Interventions

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ZG005 for Injection

intravenous infusion

Intervention Type BIOLOGICAL

Gecacitinib Hydrochloride Tablets

Oral

Intervention Type DRUG

Other Intervention Names

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ZG005 Gecacitinib

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Suzhou Zelgen Biopharmaceuticals Co.,Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jason Wu

Role: STUDY_CHAIR

Suzhou Zelgen Biopharmaceuticals Co.,Ltd

Locations

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The First Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Shuangyu Jia

Role: CONTACT

+86-0512-57018310

Facility Contacts

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Jie Jin

Role: primary

Other Identifiers

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ZG005-JAK-002

Identifier Type: -

Identifier Source: org_study_id

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