Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-26 @ 1:35 PM
Study NCT ID:
NCT06027957
Status:
COMPLETED
Last Update Posted:
2025-08-26
First Post:
2023-07-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR T-Cell Therapy for R/R Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
Sponsor:
Vinmec Research Institute of Stem Cell and Gene Technology
Organization:
Study Overview
Official Title:
Phase I Clinical Trial Evaluating the Safety and Efficacy of Point-of-care CAR-T-cell Therapy in the Treatment of Relapsed/Refractory CD19+ Non-Hodgkin Lymphoma and Acute Lymphoblastic Leukemia
Status:
COMPLETED
Status Verified Date:
2025-08
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:
* Brief Summary: Cluster of differentiation 19 (CD19) is expressed on B cells. CD19+ tumor cells in patients with non-Hodgkin lymphoma and acute lymphoblastic leukemia can be targeted using T cells expressing CD19-specific chimeric antigen receptor (CAR).
* Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
* Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
* Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
* Objective: This study aims to evaluate the safety and efficacy of single-dose anti-CD19 CAR T-cell therapy in the treatment of relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
* Eligibility: People aged 1 to 60 years with relapsed/refractory CD19+ non-Hodgkin lymphoma and acute lymphoblastic leukemia.
* Design: Phase 1 clinical trial, uncontrolled, single dose of CD19 CAR T-cells.
Detailed Description:
Objectives:
* Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy.
* Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria:
* Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion
* Progression-free survival (PFS) after infusion of CD19 CAR T-cells
* Event-free survival (EFS) after infusion of CD19 CAR T-cells
* Overall survival (OS) after infusion of CD19 CAR T-cells
* Evaluate the frequency and severity of adverse events and serious adverse events (AEs/SAEs) of the therapy.
* Evaluate the response rate after CD19 CAR T-cell infusion according to the following criteria:
* Proportion of patients with complete response and partial response after CD19 CAR T-cell infusion
* Progression-free survival (PFS) after infusion of CD19 CAR T-cells
* Event-free survival (EFS) after infusion of CD19 CAR T-cells
* Overall survival (OS) after infusion of CD19 CAR T-cells
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?: