Actively Recruiting
CS-206 in Patients With Sickle Cell Disease
Led by CorrectSequence Therapeutics Co., Ltd · Updated on 2026-02-10
5
Participants Needed
1
Research Sites
147 weeks
Total Duration
On this page
Sponsors
C
CorrectSequence Therapeutics Co., Ltd
Lead Sponsor
F
First Affiliated Hospital of Guangxi Medical University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-101 injection in treating sickle cell disease.
CONDITIONS
Official Title
CS-206 in Patients With Sickle Cell Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be between 12 to 35 years old (inclusive) and provide written informed consent.
- Documented βS/βS, βS/β0, or βS/β+ genotype.
- At least two occurrences of acute pain crisis, acute chest syndrome, priapism, or stroke/TIA within 2 years prior to screening, or red cell alloimmunization with ongoing chronic transfusions, or failure/intolerance/refusal/unavailability of standard sickle cell disease care.
- Hemoglobin S level ≥30% of total hemoglobin before transfusion.
- Fetal hemoglobin (HbF) less than 20% at screening.
- Karnofsky or Lansky performance score of 70 or higher, indicating sufficient functional status.
- Willingness to comply with study requirements, contraception, follow-up visits, and examinations.
You will not qualify if you...
- Female participants who are pregnant, breastfeeding, or planning pregnancy during the study.
- Participation in another investigational drug trial within 30 days or 5 half-lives prior to screening.
- Use of luspatercept treatment within 3 months prior to screening.
- Prior gene therapy for sickle cell disease.
- Scheduled for allogeneic hematopoietic stem cell transplantation with a fully matched related donor.
- More than 10 unplanned hospitalizations or emergency visits in the past 12 months related to chronic pain.
- Severe liver dysfunction (AST or ALT >3× upper limit normal, or INR >1.5× upper limit normal).
- Severe renal impairment (creatinine clearance <30 mL/min/1.73 m²).
- Active infections including HIV, CMV, EBV, Treponema pallidum, HBV, HCV, tuberculosis, parasitic infections, or other active bacterial, viral, or fungal infections.
- Unsuitability for autologous hematopoietic stem cell transplantation as determined by the investigator.
- Other conditions deemed unsuitable for the study by the investigator.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Guangxi Medical University
Nanning, Guangxi, China
Actively Recruiting
Research Team
Y
Yaliang Li
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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