Actively Recruiting
Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease
Led by The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army · Updated on 2024-06-03
5
Participants Needed
1
Research Sites
159 weeks
Total Duration
On this page
Sponsors
T
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Lead Sponsor
G
Guangzhou Reforgene Medicine Co., Ltd.
Collaborating Sponsor
AI-Summary
What this Trial Is About
The purpose of this study is to evaluate the safety and efficacy of RM-004 for Hemoglobin H-Constant Spring disease.
CONDITIONS
Official Title
Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Subjects voluntarily sign informed consent and complete study procedures, follow-up, and treatment.
- Age between 12 and 35 years at screening, any gender.
- History of at least 100 mL/kg/year packed red blood cell transfusions in the two years before screening.
- Diagnosed with Hemoglobin H-Constant Spring disease (--/\u03b1\u03b1CS) with HBA2 c.427T>C mutation.
You will not qualify if you...
- Having an available HLA-matched or well-matched donor for allogeneic hematopoietic stem cell transplantation.
- Prior hematopoietic stem cell transplantation or gene therapy.
- History of severe bleeding disorders.
- Clinically significant active bacterial, viral, fungal, or parasitic infections at screening.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Nanning, Guangxi, China
Actively Recruiting
Research Team
X
Xinhua Zhang, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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