Ignite Creation Date:
2024-05-06 @ 7:54 PM
Last Modification Date:
2024-10-26 @ 3:16 PM
Study NCT ID:
NCT06179524
Status:
RECRUITING
Last Update Posted:
2023-12-22
First Post:
2023-12-01
Brief Title:
CAR-T-19 Injection in the Treatment of CD19-positive RelapsedRefractory B-ALL
Sponsor:
Beijing Yongtai Ruike Biotechnology Company Ltd
Organization:
Beijing Yongtai Ruike Biotechnology Company Ltd
Study Overview
Official Title:
Phase II Clinical Study of CAR-T-19 Anti-CD19 Single-chain Antibody Chimeric Antigen Receptor T Cell Injection in the Treatment of CD19-positive RelapsedRefractory B-cell Acute Lymphoblastic LeukemiaB-ALL Under 25 Years of Age Inclusive
Status:
RECRUITING
Status Verified Date:
2023-12
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:
This is a phase II clinical study to evaluate the safety and efficacy of CAR-T-19 injection in the treatment of CD19-positive relapsedrefractory B-cell acute lymphoblastic leukemia
Detailed Description:
This is a multiple-center single-arm open-label study After meeting the eligibility criteria and enrolling on the trial patients will undergo leukapheresis for collection of autologous lymphocytes patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide 300mgm2 and fludarabine 30mgm2 for 3 consecutive days followed by the infusion of CD19 CAR T-cells at a target dose of 15 x106 cellskgrange 05-15106 cellskg
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