Trials / Recruiting
RecruitingNCT05623982
A Study of GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma
An Open, Multicenter, Phase Ib/II Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Antitumor Activity of Tetra-specific Antibody GNC-038 Injection in Patients With Relapsed or Refractory Non-Hodgkin's Lymphoma (NHL)
- Status
- Recruiting
- Phase
- Phase 1 / Phase 2
- Study type
- Interventional
- Enrollment
- 40 (estimated)
- Sponsor
- Sichuan Baili Pharmaceutical Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2D of GNC-038, or the MAD and DLT
Detailed description
phase Ib: To explore the safety and preliminary efficacy of GNC-038 in patients with relapsed or refractory NHL, and to determine the MTD and RP2Dof GNC-038, or the MAD and DLT of GNC-038 if MTD is not reached, by intravenous infusion (IV, QW) once a week (2 weeks as a cycle) phase II To explore the efficacy of GNC-038 in patients with relapsed or refractory non-Hodgkin's lymphoma
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | GNC-038 | Administration by intravenous infusion |
Timeline
- Start date
- 2022-09-26
- Primary completion
- 2026-12-01
- Completion
- 2027-12-01
- First posted
- 2022-11-21
- Last updated
- 2025-09-29
Locations
3 sites across 1 country: China
Source: ClinicalTrials.gov record NCT05623982. Inclusion in this directory is not an endorsement.