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

Zelgen Biopharmaceuticals

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Lymphoma

Treatments: Drug: Gecacitinib Hydrochloride Tablets; Biological: ZG005 for Injection

Study type: Interventional

Funder types: Industry

Identifiers

NCT06883526

ZG005-JAK-002

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Part 1: Plan A

Experimental group

Description:

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

Treatment:

Biological: ZG005 for Injection

Drug: Gecacitinib Hydrochloride Tablets

Part 1: Plan B

Experimental group

Description:

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

Treatment:

Biological: ZG005 for Injection

Drug: Gecacitinib Hydrochloride Tablets