MedTrace Logo

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

NCT06894693 · Status: NOT_YET_RECRUITING · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 13

Last updated 2025-03-25

No results posted yet for this study

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).

Conditions

Interventions

BIOLOGICAL

RS001 injection

CD19-CAR-mbIL15-DNT Cells.

Sponsors & Collaborators

  • Guangdong Ruishun Biotech Co., Ltd

    lead INDUSTRY

Principal Investigators

  • JunYuan Qi, MD, PHD · Institute of Hematology & Blood Diseases Hospital, China

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06894693 on ClinicalTrials.gov