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Recruiting EARLY_Phase 1 NCT06565026

CS-206 in Patients With Sickle Cell Disease

Trial Parameters

Condition Sickle Cell Disease
Sponsor CorrectSequence Therapeutics Co., Ltd
Study Type INTERVENTIONAL
Phase EARLY_Phase 1
Enrollment 5
Sex ALL
Min Age 12 Years
Max Age 35 Years
Start Date 2024-09-02
Completion 2026-12-31
Interventions
CS-206

Brief Summary

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.

Eligibility Criteria

Inclusion Criteria: * Participants must be between 12 to 35 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 1. At least 2 occurrences of any of the following events within 2 years prior to screening. 1. Acute pain crisis: requiring a visit to a medical facility and administration of pain medications (opioids or intravenous NSAIDs) or red blood cell transfusions. 2. Acute chest syndrome: defined by the presence of a new pulmonary infiltrate on a chest X-ray, associated with pneumonia-like symptoms, including chest pain, fever, or respiratory distress. 3. Priapism lasting more than 2 hours and necessitating a visit to a medical facility for intervention. 4. Stroke or transient ischemic attack (TIA): confirmed by imaging studies (e

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