Long Term Follow-up Study for Subjects Administered CLBR001
Launched by CALIBR, A DIVISION OF SCRIPPS RESEARCH · Mar 12, 2025
Trial Information
Current as of April 23, 2025
Not yet recruiting
Keywords
ClinConnect Summary
In line with FDA guidance on Long Term Follow-Up (LTFU) after administration of human gene therapy products, any subject who receives CLBR001 on any Calibr treatment study will participate in LTFU on this study. Subjects will be enrolled following completion on the applicable treatment study and followed for 15 years post-CLBR001 administration in order to assess the long term safety of CLBR001.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- • Subjects who received at least one CLBR001 cell dose.
- Exclusion Criteria:
- • None
Trial Officials
Chief Medical Officer
Study Director
Calibr-Skaggs Institute for Innovative Medicines
About Calibr, A Division Of Scripps Research
Calibr, a division of Scripps Research, is a pioneering biotechnology organization dedicated to advancing the discovery and development of transformative therapies. Leveraging cutting-edge science and innovative technologies, Calibr focuses on translating high-impact research into clinically viable solutions for unmet medical needs. The organization collaborates with academic institutions, industry partners, and clinical investigators to accelerate the progress of novel treatments, particularly in the fields of immunology, oncology, and regenerative medicine. With a commitment to excellence and a patient-centered approach, Calibr aims to improve health outcomes and enhance the quality of life for patients worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Patients applied
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported