CS-206 in Patients With Sickle Cell Disease (NCT07000318) | Clinical Trial Compass
Not Yet RecruitingEarly Phase 1
CS-206 in Patients With Sickle Cell Disease
China5 participantsStarted 2026-09-30
Plain-language summary
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.
Who can participate
Age range
12 Years – 18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. At least 2 occurrences of any of the following events within 2 years prior to screening.
. Acute pain crisis: requiring a visit to a medical facility and administration of pain medications (opioids or intravenous NSAIDs) or red blood cell transfusions.
. 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.
. Priapism lasting more than 2 hours and necessitating a visit to a medical facility for intervention.
. Stroke or transient ischemic attack (TIA): confirmed by imaging studies (e.g., MRI or CT scan), including silent stroke, and overt stroke leading to neurological deficits lasting \>24 hours.
. Presence of red cell alloimmunization (\>2 antibodies) and the need for ongoing chronic transfusions.
. Participants who have failed, not tolerated, refused the standard of care for Sickle Cell Disease (SCD), or are unable to access the standard of care due to the availability
. Other situations deemed appropriate for hematopoietic stem cell transplantation according to the sickle cell anemia treatment guidelines, as determined by the investigator.
Exclusion criteria
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-206 infusion
Timeframe: From signing informed consent to 24 months post-CS-206 infusion
2
Incidence of transplant-related mortality
Timeframe: From baseline to 100 days and 12 months post-CS-206 infusion
3
Time to neutrophil engraftment
Timeframe: Up to 24 months post-CS-206 infusion
4
Time to platelet engraftment
Timeframe: Up to 24 months post-CS-206 infusion
5
All-cause mortality
Timeframe: Up to 24 months post-CS-206 infusion
6
Free from severe VOCs for 12 consecutive months (VF12)
Timeframe: starting 60 days after the last red blood cell transfusion up to 24 months