Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 6:38 PM
Ignite Modification Date:
2025-12-24 @ 6:38 PM
NCT ID:
NCT06027957
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.
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
Study:
NCT06027957
Study Brief:
Protocol Section:
NCT06027957