Ignite Creation Date:
2024-05-19 @ 5:35 PM
Last Modification Date:
2024-10-26 @ 3:30 PM
Study NCT ID:
NCT06420089
Status:
RECRUITING
Last Update Posted:
2024-05-17
First Post:
2024-04-30
Brief Title:
CD5-deleted Chimeric Antigen Receptor Cells Senza5 CART5 for T Cell Non-Hodgkin Lymphoma NHL
Sponsor:
Vittoria Biotherapeutics
Organization:
Vittoria Biotherapeutics
Study Overview
Official Title:
CD5-deleted Chimeric Antigen Receptor Cells Senza5 CART5 to Enhance Immunotherapy Against T Cell Non-Hodgkin Lymphoma NHL a First-in-human Phase I Clinical Trial
Status:
RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
VIPER101
Brief Summary:
This is an open-label phase I study to determine the safety and recommended phase 2 dose RP2D of Senza5 CART5 cells in patients with relapsed or refractory CD5 positive nodal T cell NHL RP2D will be based on the safety tolerability pharmacokinetics and preliminary efficacy of Senza5 CART5 cells This trial will evaluate up to 5 dose levels using the Bayesian Optimal Interval BOIN design enrolling 3 patients in each cohort to assess safety and achieve therapeutic levels so that the RP2D of Senza5 CART5 cells given as a single IV infusion can be determined
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None