CS-206 in Patients With Sickle Cell Disease

Sponsor
Children's Hospital of Fudan University
Study ID
NCT07000318
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
12 Years - 18 Years
Healthy Volunteers
Not accepted

Interventions

  • CS-206 — GENETIC
    Autologous CD34+ hematopoietic stem cell suspension modified by ex vivo base editing technique

Study Details

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.

Key Dates

First listed
Jun 2, 2025
Start date
Sep 30, 2026
Status verified
May 2026
Primary completion
Dec 30, 2028
Completion
Mar 31, 2029

Study Design

Enrollment
5 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: CS-206
    Autologous CD34+ hematopoietic stem cell suspension modified by ex vivo base editing technique

Primary Outcome Measure

AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-206 infusion [ Time Frame: From signing informed consent to 24 months post-CS-206 infusion ]

Central Contacts

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