Ignite Creation Date:
2025-12-25 @ 12:59 AM
Ignite Modification Date:
2026-02-20 @ 6:38 PM
Study NCT ID:
NCT05420493
Status:
UNKNOWN
Last Update Posted:
2024-01-05
First Post:
2022-06-12
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Clinical Study of Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of Relapsed/Refractory Non-Hodgkin Lymphoma
Sponsor:
Chongqing Precision Biotech Co., Ltd
Organization:
Study Overview
Official Title:
This is a Phase I Clinical Study to Evaluate the Safety and Efficacy of CAR-T Infusion Preparation in the Treatment of CD19-positive Relapsed/Refractory Non-Hodgkin Lymphoma.
Status:
UNKNOWN
Status Verified Date:
2023-11
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 phase I clinical study to evaluate the safety and efficacy of CAR-T infusion preparation in the treatment of CD19-positive relapsed/refractory non-Hodgkin lymphoma.
Detailed Description:
This is a single-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. Once cells have been manufactured, patients will then proceed to lymphodepleting chemotherapy with cyclophosphamide and fludarabine for 1-2 consecutive days followed by the infusion of CAR T-cells at a target dose of 3-10x105 cells/kg.
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?: