Ignite Creation Date:
2025-12-24 @ 2:12 PM
Ignite Modification Date:
2025-12-30 @ 12:20 AM
Study NCT ID:
NCT05487495
Status:
WITHDRAWN
Last Update Posted:
2024-11-14
First Post:
2022-08-01
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Donor-Derived CD5 CAR T (CT125B) Cells for Relapsed or Refractory T- Cell Acute Lymphoblastic Leukemia/Lymphoma
Sponsor:
Beijing Boren Hospital
Organization:
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 Leukemia/Lymphoma
Status:
WITHDRAWN
Status Verified Date:
2022-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
ethic commitee decisiong
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 leukemia/lymphoma. 9-18 subjects will be enrolled. After the collection of PBMC and about 5 days before infusion, lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 250 mg/m\^2/day; for prior-SCT donor-derived CAR T-cell infusion) or intensified lymphodepletion (fludarabine at 30 mg/m\^2/day and cyclophosphamide at 30 mg/kg/day; for new donor-derived CAR T-cell infusion) will be administrated for 3 days.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10\^6 (±20%) to dose 2: 2×10\^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10\^5 (±20%) /kg.
Then this study will be using BOIN1/2 approach from starting dose 1: 1×10\^6 (±20%) to dose 2: 2×10\^6 (±20%). If the manufactured cells were not sufficient to meet the preassigned standard dose criteria, patients are given infusion at a low dose of 5×10\^5 (±20%) /kg.
Detailed Description:
None
Study Oversight
Has Oversight DMC:
True
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?:
False
Is an FDA AA801 Violation?: