NCT06107400 Safety and Efficacy of RM-004 Cells for Hemoglobin H-Constant Spring Disease
| NCT ID | NCT06107400 |
| Status | Recruiting |
| Phase | EARLY_Phase 1 |
| Sponsor | The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army |
| Condition | Alpha Thalassemia Hemoglobin H Constant Spring |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2023-10-08 |
| Primary Completion | 2025-10-31 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2023-10-08 with a primary completion date of 2025-10-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to evaluate the safety and efficacy of RM-004 for Hemoglobin H-Constant Spring disease.
Eligibility Criteria
Inclusion Criteria: 1. Subjects voluntarily sign informed consent by themselves or their legal guardians and complete the study procedures, follow-up examination and treatment. 2. At the time of screening, subjects should be aged from 12 to 35 years old, regardless of gender. 3. History of at least 100 mL/kilograms (kg)/year of packed red blood cells (pRBC) transfusions in the prior 2 years before screening. 4. Subjects diagnosed with Hemoglobin H-Constant Spring disease (--/ααCS) with HBA2 c.427T\>C mutation. Exclusion Criteria: 1. Subject who has an available HLA-matched/well-matched HSCT donor for allogeneic hematopoietic stem cell transplantation (HSCT). 2. Prior HSCT or gene therapy. 3. History of severe hemorrhagic disease. 4. Clinically significant active bacterial, viral, fungal or parasitic infections per investigator's judgement at the time of screening.
Contact & Investigator
Xinhua Zhang, MD
PRINCIPAL INVESTIGATOR
The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army
Frequently Asked Questions
Who can join the NCT06107400 clinical trial?
This trial is open to participants of all sexes, aged 12 Years or older, up to 35 Years, studying Alpha Thalassemia Hemoglobin H Constant Spring. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06107400 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06107400 currently recruiting?
Yes, NCT06107400 is actively recruiting participants. Contact the research team at zxh303@163.com for enrollment information.
Where is the NCT06107400 trial being conducted?
This trial is being conducted at Nanning, China.
Who is sponsoring the NCT06107400 clinical trial?
NCT06107400 is sponsored by The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army. The principal investigator is Xinhua Zhang, MD at The 923rd Hospital of Joint Logistics Support Force of People's Liberation Army. The trial plans to enroll 5 participants.