Clinical Study of 1A46 Drug Substance

Advanced Malignancies Clinical Trial

Official title: A Phase I/II, First in Human, Single Arm, Open Label Study to Evaluate the Safety and Efficacy of the Injection of Triple-specific T-cell Engager 1A46in Adult Subjects With R/R CD20 Positive and/or CD19 Positive B Cell Non-Hodgkin's Lymphoma (B - NHL)

Status Not yet recruiting

Clinical Trial Summary

A phase I/II, first in human, single arm, open label study to evaluate the safety and efficacy of the injection of triple-specific T-cell engager 1A46 in adult subjects with R/R CD20 positive and/or CD19 positive B cell non-Hodgkin's lymphoma (B - NHL)

Clinical Trial Description

This study is an open-label, multicenter, Phase 1 dose escalation and Phase 2 dose expansion study of 1A46 in adult patients with advanced relapsed/refractory (r/r) CD20 and/or CD19positive B-cell NHL for whom there is not available effective standard treatment . This study is the FIH study of 1A46 in China. This FIH study will include a dose escalation (Phase 1 part) and a dose expansion in 3 cohorts (Phase 2 part). If specific criteria for efficacy are met in one or more of the Phase 2 cohorts, a statistically validated number of additional patients will be enrolled with the goal of accelerated approval The starting dose for phase I is C1D1 1μg，C1D8 1μg，C1D15 and C2D1 afterwards 1 μg, followed by 10 dose cohorts. Duration of dose limiting toxicity (DLT) observation is 28 days.One cycle is defined as 21 days. Patients will be scheduled to receive weekly injection of 1A46 for the first cycles (3 weeks) and then for the remaining 15 cycles, the study patients will receive a single injection of 1A46 per cycle (every 3 weeks [Q3W]). ;

Related Conditions & MeSH terms

• Advanced Malignancies
• Neoplasms

• NCT number: NCT05987605
• Study type: Interventional
• Source: BioRay Pharmaceutical Co., Ltd.
• Contact: Zhu Jun, Doctor
• Phone: +8613910333346
• Email: zhujun3346@163.com
• Status: Not yet recruiting
• Phase: Phase 1
• Start date: October 1, 2023
• Completion date: April 30, 2030