CS-206 in Patients With Sickle Cell Disease
ConditionSickle Cell Disease
Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age12-18
SponsorChildren's Hospital of Fudan University
About this trial
The goal of this open label, single-arm clinical study is to learn about the safety and efficacy of CS-206 injection in treating sickle cell disease.
Eligibility criteria
Qualifiers
Participants must be between 12 to 18 years old (inclusive). Participants or their legal guardians (for participants below 18 years old) must provide written informed consent before any study-related procedures.
Participants must have a Documented βS/βS, βS/β0 or βS/β+ genotype.
Participants must have at least one of the following conditions
At least 2 occurrences of any of the following events within 2 years prior to screening.
Disqualifiers
Female participants who are pregnant, breastfeeding, or planning pregnancy during the study period are excluded.
Participation in another investigational drug trial within 30 days prior to screening or within 5 half-lives (whichever is longer).
Subjects who have received or are receiving luspatercept treatment within 3 months prior to screening.
Subjects who have previously received any gene therapy for the disease.
Trial design
Treatments tested in this trial
- CS-206
Treatment groups
5 Participants
are divided into 1 treatment groupSponsors and collaborators
Source ClinicalTrials.gov