ZG005 with gecacitinib for relapsed or refractory lymphoma
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
PHASE1; PHASE2 · Suzhou Zelgen Biopharmaceuticals Co.,Ltd · NCT06883526
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Suzhou Zelgen Biopharmaceuticals Co.,Ltd (industry) |
| Drugs / interventions | Gecacitinib |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06883526 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Hangzhou, Zhejiang
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Lymphoma