NCT06021678

Safety and Efficacy of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

A Phase I/II Study Evaluating the Safety, Efficacy, and Pharmacokinetics of EX103 in Subjects with Relapsed/Refractory CD20-Positive Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 415 (estimated)
• Sponsor: Guangzhou Excelmab Inc. · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

This is a multicenter, single-arm, open, dose-escalation Phase I/II clinical trial, consisting of a dose-escalation phase (accelerated titration phase, 3+3 design) and a dose expansion phase.

Detailed description

Based on the safety, tolerability, PK results, and antitumor activity of EX103 in patients with relapsed or refractory CD20-positive non-Hodgkin lymphoma, this study will determine dose-limiting toxicity (DLT) and determine the maximum tolerated dose (MTD) or optimal biological dose (OBD) to provide a basis for the recommended Phase 2 dose (RP2D). The dose expansion phase will further evaluate the safety, tolerability, PK, PD profile, initial antitumor effect, and immunogenicity of several extended cohorts.

Conditions

• CD20-positive Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	EX103 injection	Administered as specified in the treatment arm.

Timeline

• Start date: 2021-11-12
• Primary completion: 2025-10-01
• Completion: 2025-12-01
• First posted: 2023-09-01
• Last updated: 2025-02-27

Locations

4 sites across 1 country: China

Regulatory

• FDA-regulated drug study