MedTrace Logo

Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease

NCT06107400 · Status: RECRUITING · Phase: EARLY_PHASE1 · Type: INTERVENTIONAL · Enrollment: 5

Last updated 2024-06-03

No results posted yet for this study

Summary

The purpose of this study is to evaluate the safety and efficacy of RM-004 for Hemoglobin H-Constant Spring disease.

Conditions

  • Alpha Thalassemia Hemoglobin H Constant Spring
  • Hemoglobinopathies
  • Hereditary Diseases

Interventions

GENETIC

RM-004

Intravenous infusion of gene-edited CD34+autologous hematopoietic stem cells (RM-004) after myeloablative conditioning with busulfan.

Sponsors & Collaborators

  • Guangzhou Reforgene Medicine Co., Ltd.

    collaborator UNKNOWN

  • The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army

    lead OTHER

Principal Investigators

  • Xinhua Zhang, MD · The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
12 Years
Max Age
35 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-10-08
Primary Completion
2025-10-31
Completion
2026-10-31

Countries

  • China

Study Locations

More Related Trials

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 NCT06107400 on ClinicalTrials.gov