Ignite Creation Date:
2024-10-26 @ 3:43 PM
Last Modification Date:
2024-10-26 @ 3:43 PM
Study NCT ID:
NCT06652633
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-10-21
Brief Title:
Long-term Follow-up of Participants Treated with Galapagos Chimeric Antigen Receptor CAR T-cell Therapies
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Long-term Follow-up Study for Patients Treated with Galapagos CAR T-cell Therapies
Status:
RECRUITING
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
Hesperia
Brief Summary:
This is a long-term follow-up study for participants treated with Galapagos GLPG CAR T-cell therapies to evaluate the long-term safety and efficacy of GLPG CAR T-cell products for 15 years post infusion
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors eg lentiviral vectors long term safety and efficacy follow up of treated patients is required The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events AEs and the long-term benefitrisk profile and to monitor for replication-competent lentivirus RCL and CAR-T cell persistence
Per Health Authorities guidelines for gene therapy medicinal products that utilize integrating vectors eg lentiviral vectors long term safety and efficacy follow up of treated patients is required The purpose of this study is to monitor all participants exposed to GLPG CAR T-cell therapies for 15 years following their last CAR T-cell infusion to assess the risk of delayed adverse events AEs and the long-term benefitrisk profile and to monitor for replication-competent lentivirus RCL and CAR-T cell persistence
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None