Status:
ACTIVE_NOT_RECRUITING
Long-term Follow-up (LTFU) of Patients Treated With Genome-edited Autologous Hematopoietic Stem and Progenitor Cells (HSPC)
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Sickle Cell Disease
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
Brief Summary
CADPT03A12001 is a prospective, multi-center study that is designed to follow all enrolled patients who have received treatment with OTQ923 for long-term safety and efficacy.
Detailed Description
This study is monitoring patients treated with OTQ923, an investigational drug product of ex vivo genome-edited autologous hematopoietic stem and progenitor cells (HSPCs) that induces fetal hemoglobin...
Eligibility Criteria
Inclusion
- Patients must have received gene therapy treatment from the parent treatment protocol (CADPT03A12101).
- Patients must provide informed consent prior to their entry into this study.
Exclusion
- 1\. Completion of less than 1 year of safety follow-up in the treatment protocol (CADPT03A12101).
Key Trial Info
Start Date :
April 16 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 11 2039
Estimated Enrollment :
4 Patients enrolled
Trial Details
Trial ID
NCT06155500
Start Date
April 16 2024
End Date
January 11 2039
Last Update
October 3 2025
Active Locations (3)
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1
University of Chicago
Chicago, Illinois, United States, 60637
2
Memorial Sloan Kettering Cancer Ctr
New York, New York, United States, 10065
3
St Jude Childrens Research Hospital
Memphis, Tennessee, United States, 38105