drugset / Trial / NCT06894693

A Phase I Clinical Trial of RS001 in Patients with Relapsed/Refractory B-Cell Malignancies

NCT06894693 ↗

Phase 1 Not yet recruiting 13 enrolled Guangdong Ruishun Biotech Co., Ltd
NaSingle-groupOpen-labelTreatment

Summary

This study is an open-label, single-arm, dose-escalation and dose-expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic profile in the body after infusion of RS001 injection, and preliminary efficacy in subjects with CD19-positive relapsed/refractory B-cell malignancies (BCM).

Timeline

Start
2025-04-01
Primary completion
2026-04-01
Completion
2028-04-01

Drugs

EvaluationDrugModalityDoseRoute
Subject RS001 Cell therapy 5e+06 cells/kg —
Subject RS001 Cell therapy 1e+07 cells/kg —
Subject RS001 Cell therapy 2e+07 cells/kg —