Ignite Creation Date:
2024-05-06 @ 5:56 PM
Last Modification Date:
2024-10-26 @ 2:38 PM
Study NCT ID:
NCT05487495
Status:
UNKNOWN
Last Update Posted:
2022-08-04
First Post:
2022-08-01
Brief Title:
Donor-Derived CD5 CAR T CT125B Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic LeukemiaLymphoma
Sponsor:
Beijing Boren Hospital
Organization:
Beijing Boren Hospital
Study Overview
Official Title:
First-in-Human FIH Open-Label Non-Randomized Single-Arm Phase 1 Study to Evaluate the Safety and Tolerability of Donor-Derived CD5 CAR T CT125B Cells forRelapsed or Refractory T-Cell Acute Lymphoblastic LeukemiaLymphoma
Status:
UNKNOWN
Status Verified Date:
2022-08
Last Known Status:
RECRUITING
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:
This is a FIH single center open label non-randomized single-arm Phase I clinical trial to evaluate the safety and tolerability of CD5 CAR T CT125B cells in subjects with relapsed or refractory T-cell acute lymphoblastic leukemialymphoma 9-18 subjects will be enrolled After the collection of PBMC and about 5 days before infusion lymphodepletion fludarabine at 30 mgm2day and cyclophosphamide at 250 mgm2day for prior-SCT donor-derived CAR T-cell infusion or intensified lymphodepletion fludarabine at 30 mgm2day and cyclophosphamide at 30 mgkgday for new donor-derived CAR T-cell infusion will be administrated for 3 days
Then this study will be using BOIN12 approach from starting dose 1 1106 20 to dose 2 2106 20 If the manufactured cells were not sufficient to meet the preassigned standard dose criteria patients are given infusion at a low dose of 5105 20 kg
Then this study will be using BOIN12 approach from starting dose 1 1106 20 to dose 2 2106 20 If the manufactured cells were not sufficient to meet the preassigned standard dose criteria patients are given infusion at a low dose of 5105 20 kg
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
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