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CS-206

Phase 1

Sickle Cell Disease | Gene therapy | Hematology |cbdMD, Inc.|Last Updated: Feb 10, 2026

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment5

FDA Designations

No designations recorded

Clinical trial landscape

CS-206 · 1 trial · 1 indication

Early Phase 1 1
NCT06565026CS-206 in Patients With Sickle Cell DiseaseSickle Cell Disease
RECRUITING5 Analytics
EARLY_PHASE1RECRUITING
CS-206 in Patients With Sickle Cell Disease
Sickle Cell DiseaseUnlock trial analytics

Study Endpoints

Primary Endpoints

AEs(Adverse Events) and SAEs(Serious Adverse Events) after CS-101 infusion
From signing informed consent to 24 months post-CS-206 infusion

Frequency and severity of adverse events(AEs)as assessed by CTCAE(Common Terminology Criteria for Adverse Events)v5.0

Incidence of transplant-related mortality
From baseline to 100 days and 12 months post-CS-206 infusion

Incidence of transplant-related mortality(Transplant-related mortality events defined as deaths assessed by the investigator as potentially transplant-related)

Time to neutrophil engraftment
Up to 24 months post-CS-206 infusion

Time to neutrophil engraftment is defined as first day of 3 consecutive measurements of absolute neutrophil count≥0.5×10\^9/L on three different days.

Time to platelet engraftment
Up to 24 months post-CS-206 infusion

Time to platelet engraftment is defined as first day of 3 consecutive measurements of absolute platelet count≥20×10\^9/L on three different days and without platelet transfusion.

All-cause mortality
Up to 24 months post-CS-206 infusion
Free from severe VOCs for 12 consecutive months (VF12)
starting 60 days after the last red blood cell transfusion up to 24 months

Free from severe vaso-occlusive crises (VOCs) for 12 consecutive months (VF12)

Secondary Endpoints

Free from hospitalization due to severe vaso-occlusive crises for 12 consecutive months(HF12)
starting 60 days after the last red blood cell transfusion up to 24 months
Free from severe VOCs for 9 consecutive months (VF9)
starting 60 days after the last red blood cell transfusion up to 24 months
Annualized incidence of severe vaso-occlusive crises (VOC)
starting 60 days after the last red blood cell transfusion up to 24 months
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CS-206EXPERIMENTALAutologous CD34+ hematopoietic stem cell suspension modified by in vitro base editing technique

Interventions

NameTypeDescription
CS-206GENETICAutologous CD34+ hematopoietic stem cell suspension modified by in vitro base editing technique
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Eligibility Criteria

Age Range12 Years to 35 Years
SexALL
Healthy VolunteersNo
Study Sites1

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+ genot...

Countries:China
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Frequently asked questions about CS-206

What is CS-206 used for?

CS-206 is an investigational gene therapy being developed for the treatment of Sickle Cell Disease. It is currently in early Phase 1 clinical development and has not been approved by regulatory authorities.

Who is developing CS-206?

CS-206 is being developed by cbdMD, Inc., a company publicly traded under the ticker YCBD. The company is conducting clinical trials for this gene therapy candidate in Sickle Cell Disease.

What phase is CS-206 in?

CS-206 is in Phase 1 clinical development. Specifically, it is being studied in an early Phase 1 trial that is currently recruiting participants. The drug is investigational and has not been approved for commercial use.

What clinical trials is CS-206 in?

CS-206 is being evaluated in a single clinical trial with the identifier NCT06565026, titled 'CS-206 in Patients With Sickle Cell Disease'. This early Phase 1 study is recruiting up to 5 participants in China and is not randomized or blinded.

Is CS-206 a gene therapy?

Yes, CS-206 is a gene therapy. It is being studied as a potential treatment for Sickle Cell Disease, a hematologic condition. The ongoing clinical trial includes biomarker selection for participants.