ZG005 with gecacitinib for relapsed or refractory lymphoma
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
Run by Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06883526 · Data updated 2026-11-12
We are testing whether ZG005 given with gecacitinib is safe and helps adults whose lymphoma has come back or hasn't responded to prior treatments.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 60 (estimated) |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd Industry-sponsored |
| Drugs / interventions | Gecacitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Status | Recruiting |
| Started | May 16, 2025 |
| Main results expected | April 2027 |
| Study ends | May 2027 |
| Registry record updated | January 5, 2026 |
| Trial ID | NCT06883526 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults (≥18) with histologically confirmed relapsed or refractory lymphoma who can consent and do not have CNS involvement or serious cardiovascular/cerebrovascular disease are the intended participants.
✕Probably not a fit
Patients with known CNS involvement, severe heart or stroke-related conditions, or other investigator-determined reasons are unlikely to be eligible or to benefit from participation.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This Phase 1/2 interventional trial enrolls adults with histologically confirmed relapsed or refractory lymphoma to receive ZG005 injections plus oral gecacitinib. Part 1 (Phase 1) will explore safety and tolerability and determine the recommended Phase 2 dosing regimen for the combination. Part 2 (Phase 2) will then test the combination's efficacy in the same patient population using the dose selected from Part 1. Key exclusions include known CNS lymphoma and severe cardiovascular or cerebrovascular disease, and the trial is conducted at The First Affiliated Hospital, Zhejiang University School of Medicine under Suzhou Zelgen Biopharmaceuticals sponsorship.
Why it matters
Potential benefit: If successful, this combination could offer a new treatment option that controls disease in some patients with relapsed or refractory lymphoma.
How similar studies have gone: Combining targeted biologic agents with oral kinase inhibitors has shown activity in certain lymphomas, but the specific ZG005 plus gecacitinib combination is investigational with limited public data to date.
Who can join: the full rules
Show full inclusion / exclusion 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.
Where it's running
-
The First Affiliated Hospital, Zhejiang University School of Medicine
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Shuangyu Jia
- Email: jiasy@zelgen.com
- Phone: +86-0512-57018310
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.