Ignite Creation Date:
2024-05-06 @ 8:11 PM
Last Modification Date:
2024-10-26 @ 3:22 PM
Study NCT ID:
NCT06285422
Status:
RECRUITING
Last Update Posted:
2024-05-31
First Post:
2024-02-22
Brief Title:
Study Evaluating SC262 in Subjects with Rr Non-Hodgkins Lymphoma VIVID
Sponsor:
Sana Biotechnology
Organization:
Sana Biotechnology
Study Overview
Official Title:
A Phase 1 Study Evaluating SC262 a Hypoimmune Allogeneic CD22-directed CAR T Cell Therapy in Relapsed Andor Refractory Non-Hodgkins Lymphoma VIVID
Status:
RECRUITING
Status Verified Date:
2024-09
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:
None
Brief Summary:
SC262-101 is a Phase 1 study to evaluate SC262 safety and tolerability anti-tumor activity cellular kinetics immunogenicity and exploratory biomarkers
Detailed Description:
This is an open-label single arm Phase 1 first-in-human FIH study to evaluate the safety and tolerability of SC262 administered intravenously IV following a standard lymphodepleting chemotherapy regimen of cyclophosphamide and fludarabine in subjects with Non Hodgkins Lymphoma NHL who have received no more than 1 prior CD19-directed Chimeric Antigen Receptor T-Cells CAR T cell therapy This study will be conducted in 2 parts Dose finding using a 33 design in subjects with NHL Dose expansion to further evaluate safety and efficacy at the recommended phase 2 dose RP2D in subjects with Large B-Cell Lymphoma LBCL
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