Lymphoma
Conditions
Brief summary
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
BIOLOGICALZG005 for Injection
intravenous infusion
Sponsors
Suzhou Zelgen Biopharmaceuticals Co.,Ltd
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Objective response rate (ORR) | Up to 2 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Immunogenicity | Up to 2 years | Incidence of antidrug antibodies (ADA) |
Countries
China
Contacts
Primary ContactShuangyu Jia
Outcome results
None listed