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 @ 8:02 PM
Ignite Modification Date:
2025-12-24 @ 8:02 PM
NCT ID:
NCT07277504
Brief Summary:
The purpose of this clinical trial is to learn if autologous bedside CD19-directed chimeric antigen receptor T-cell (CAR-T) therapy works to treat B-cell acute lymphoblastic leukemia (B-ALL) in adults. It will also learn about the safety and efficacy of the autologous bedside CD19 CAR-T cell product.
The main questions it aims to answer are:
1. What adverse events occur and the incidence rate of dose-limiting toxicities (DLTs) within 28 days and CAR-T-related adverse events (AEs) after the autologous CD19 CAR-T cell infusion for B-ALL?
2. Which dose level is the optimal biological dose (OBD)?
3. What is the rate of minimal residual disease (MRD) negativity, complete remission (CR) or complete remission with incomplete hematologic recovery (CRi), duration of response (DOR), and overall survival (OS)?
Participants will:
1. Receive autologous bedside CD19 CAR T-cell therapy on Day 0.
2. Be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days.
3. Visit the clinic at Day 7, Day 14, Day 28, then monthly for up to 12 months after CAR-T cells infusion, with continued long-term follow-up for safety and persistence.
Study:
NCT07277504
Study Brief:
Protocol Section:
NCT07277504