Ignite Creation Date:
2024-10-26 @ 3:38 PM
Last Modification Date:
2024-10-26 @ 3:38 PM
Study NCT ID:
NCT06568328
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-03
Brief Title:
Chimeric Natural Killer Receptor-Universal T Cells for Refractory GVHD
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Study to Evaluate the Safety Tolerability Efficacy Pharmacokinetics and Pharmacodynamics of CNK-UT Cells to Treat the Patients With Steroid-refractoryResistant or Steroid-dependent GVHD
Status:
RECRUITING
Status Verified Date:
2024-08
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:
None
Brief Summary:
This is a single arm open-label multi-center pilot studies Investigator Initiated Trial IIT to evaluate the safety tolerability efficacy pharmacokinetics and pharmacodynamics of universal T-cells engineered with chimeric natural killer receptor CNK-UT to treat the patients with steroid-refractoryresistant or steroid-dependent GVHD
Detailed Description:
This is a single arm open-label phase I dose escalationdose expansion study to assess the safety and tolerability of CNK-UT cells therapy and to obtain the efficacy pharmacokinetics and pharmacodynamics result in participants who have been diagnosed with steroid-refractoryresistant or steroid-dependent GVHD
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