Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06518876
Status:
NOT_YET_RECRUITING
Last Update Posted:
None
First Post:
2024-07-08
Brief Title:
A Study of KQ-2003 CAR-T Cell Therapy for Patients With Relapsed or Refractory POEMS Syndrome
Sponsor:
None
Organization:
None
Study Overview
Official Title:
A Phase 1 Study to Evaluate the Safety Tolerability Preliminary Efficacy and Pharmacokinetic Characterization of KQ-2003 for Patients With RelapsedRefractory POEMS Syndrome
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
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 multicenter open-label dose-escalationexpansion phase 1 study to evaluate the safety tolerability pharmacokineticpharmacodynamic characteristics and determine the recommended dose of KQ-2003 CAR T-cells for patients with RelapsedRefractory POEMS Syndrome
Detailed Description:
The study included the phase 1a dose escalation study and the phase 1b cohort extension study The phase 1a study is an open dose-escalation design with 3 dose groups according to the 33 dose escalation rule low dose group 05106 CAR T cellskg medium dose group 10106 CAR T cellskg high dose group 20106 CAR T cellskg After initial confirmation of maximum tolerated dose MTD or recommended phase 2 dose RP2D a phase 1b cohort extension study will be conducted
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