A Study of GNC-038, a Tetra-specific Antibody, in Participants With R/R Diffuse Large B-cell Lymphoma (DLBCL)
NCT05192486 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 12
Last updated 2025-09-26
Summary
In this study, the safety and preliminary efficacy of GNC-038 in participants with recurrent or refractory Diffuse Large B-cell lymphoma (DLBCL) will be investigated to assess the dose-limiting toxicity (DLT), maximum tolerated dose (MTD) or maximum administered dose (MAD) for MTD is not reached of GNC-038. The recommended dose for phase II (RP2D) clinical study will also be determined.
Conditions
- Diffuse Large B-cell Lymphoma
Interventions
- DRUG
-
GNC-038
Administration by intravenous infusion
Sponsors & Collaborators
-
SystImmune Inc.
collaborator INDUSTRY -
Sichuan Baili Pharmaceutical Co., Ltd.
lead INDUSTRY
Principal Investigators
-
Weili Zhao · Ruijin Hospital
Study Design
- Allocation
- NA
- Purpose
- TREATMENT
- Masking
- NONE
- Model
- SEQUENTIAL
Eligibility
- Min Age
- 18 Years
- Max Age
- 75 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2022-08-10
- Primary Completion
- 2025-12-31
- Completion
- 2025-12-31
Countries
- China
Study Locations
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