Study of ZG005 in Combination With Gecacitinib in Patients With Relapsed or Refractory Lymphoma
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: ZG005 for Injection, Gecacitinib Hydrochloride Tablets.
- Who it may be relevant to
- Registry conditions: Lymphoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological ZG005 for Injection
intravenous infusion - Drug Gecacitinib Hydrochloride Tablets
Oral
Primary outcome measures
- Objective response rate (ORR) [Time frame: Up to 2 years]
Secondary outcome measures (1)
- Immunogenicity [Time frame: Up to 2 years]
Eligibility criteria
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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Sequential
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital, Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06883526 · ZG005-JAK-002