NCT06565689

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012

A Multi-center, Open-Label, Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Preliminary Efficacy of YK012 in Patients With Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Excyte Biopharma Ltd · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This study aims to provide a basis for further clinical development of YK012.

Detailed description

This study is the first-in-human clinical trial to evaluate the safety, tolerability, pharmacokinetic (PK) profile and preliminary efficacy of YK012 in patients with relapsed or refractory B-cell non-Hodgkin lymphoma (R/R B-NHL).

Conditions

• Relapsed or Refractory B-Cell Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	YK012	YK012 is a bispecific antibody targeting CD19 on B cells and CD3 on T cells leading to T cell-mediated cytotoxicity of malignant B cells

Timeline

• Start date: 2023-05-09
• Primary completion: 2026-06-30
• Completion: 2026-12-31
• First posted: 2024-08-22
• Last updated: 2026-02-05

Locations

1 site across 1 country: China