Clinical trial • Phase I • Immunology
Obecabtagene Autoleucel for Severe, Refractory Systemic Lupus Erythematosus | Systemic lupus erythematosus
Phase I trial of Obecabtagene Autoleucel for Severe, Refractory Systemic Lupus Erythematosus | Systemic lupus erythematosus. open-label. 6 participants.
Overview
- Trial Therapeutic Area
- Immunology
- Trial Disease
- Severe, Refractory Systemic Lupus Erythematosus | Systemic lupus erythematosus
- Trial Stage
- Phase I
- Drug Modality
- Cell therapy
Key dates
- Initial CTIS Submission Date
- 06-11-2023
- First CTIS Authorization Date
- 18-03-2024
Trial design
open-label Phase I trial across 2 sites in Spain.
- Open Label
- Yes
- Target Sample Size
- 6
Eligibility
Recruits 6 No vulnerable population selected (isVulnerablePopulationSelected=false). A Substantial Modification proposing inclusion of adolescents was submitted but was not authorised (decision states inclusion of adolescents is not authorised until further safety/efficacy data are available)..
- Vulnerable Population
- No vulnerable population selected (isVulnerablePopulationSelected=false). A Substantial Modification proposing inclusion of adolescents was submitted but was not authorised (decision states inclusion of adolescents is not authorised until further safety/efficacy data are available).
Recruitment
- Planned Sample Size
- 6
- Recruitment Window Months
- 55
Geography
- Total Number Of Sites
- 2
- Total Number Of Participants
- 6
Spain
- Earliest CTIS Part Ii Submission Date
- 09-02-2024
- Latest Decision Or Authorization Date
- 23-05-2025
- Processing Time Days
- 469
- Number Of Sites
- 2
- Number Of Participants
- 6
Sites
- Site Name
- Hospital Universitario Y Politecnico La Fe
- Department Name
- Rheumatology
- Principal Investigator Name
- Jose Andres Romano Ivorra
- Principal Investigator Email
- roman_jan@gva.es
- Contact Person Name
- Jose Andres Romano Ivorra
- Contact Person Email
- roman_jan@gva.es
- Site Name
- Hospital Vall d’Hebron
- Department Name
- Lupus Unit Vall d’Hebron Institut de Recerca (VHIR)
- Principal Investigator Name
- Josefina Cortés Hernández
- Principal Investigator Email
- fina.cortes@vhir.org
- Contact Person Name
- Josefina Cortés Hernández
- Contact Person Email
- fina.cortes@vhir.org
Sponsor
Primary sponsor
- Full Name
- Autolus Limited
- Organisation Type
- Pharmaceutical company
- Country Of Registered Address
- United Kingdom
Investigational products
- Investigational Product Name
- Obecabtagene Autoleucel
- Active Substance
- Obecabtagene Autoleucel
- Modality
- Cell therapy
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