Ignite Creation Date:
2025-12-25 @ 1:31 AM
Ignite Modification Date:
2025-12-27 @ 11:27 PM
Study NCT ID:
NCT07072494
Status:
RECRUITING
Last Update Posted:
2025-07-18
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study
Sponsor:
Zhujiang Hospital
Organization:
Study Overview
Official Title:
Clinical Study on the Efficacy and Safety of CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-Lymphoblastic Leukemia Who Are Ineligible for Allogeneic Hematopoietic Stem Cell Transplantation
Status:
RECRUITING
Status Verified Date:
2025-02
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 clinical study investigates a novel treatment option for adolescents and adults with acute B-lymphoblastic leukemia (B-ALL). While allogeneic hematopoietic stem cell transplantation (HSCT) is a standard therapy for leukemia, some patients are ineligible due to factors such as age, underlying medical conditions, or the absence of a suitable donor. For these individuals, CD19 CAR-T cell therapy is being evaluated as a potential consolidation therapy.
Detailed Description:
This is an open-label, single-arm, prospective clinical study designed to evaluate the clinical effectiveness and safety of CD19-directed chimeric antigen receptor T (CAR-T) cell therapy as a consolidation treatment in adolescent and adult patients with acute B-ALL who are ineligible for allogeneic HSCT. The study is planned to be conducted over a period of three years, enrolling a total of 30 participants.The primary objective of this study is to assess the clinical effectiveness of CD19 CAR-T cell therapy as a consolidation therapy in achieving remission and improving survival outcomes in the specified patient population. Specifically, the study aims to:
Evaluate the efficacy of CD19 CAR-T cell therapy in achieving complete remission (CR) or minimal residual disease-negative (MRD-) status in patients with B-ALL.
Assess the safety and tolerability of the treatment, with a focus on key adverse events.
Eligible participants will receive CD19 CAR-T cell infusion following a standard lymphodepleting chemotherapy regimen. After infusion, patients will be closely monitored for both short-term and long-term outcomes. Safety Considerations:
Patients will be closely monitored for treatment-related toxicities. Early intervention strategies for CRS and neurotoxicity will be implemented as per established management guidelines. Supportive care, including corticosteroids and anti-cytokine therapies, will be available for severe toxicities.
This study seeks to provide valuable clinical evidence regarding the use of CD19 CAR-T cell therapy as a consolidation strategy for B-ALL patients who are not candidates for HSCT. By evaluating both efficacy and safety parameters, the study aims to contribute to the growing body of knowledge surrounding CAR-T therapies in hematologic malignancies.
Evaluate the efficacy of CD19 CAR-T cell therapy in achieving complete remission (CR) or minimal residual disease-negative (MRD-) status in patients with B-ALL.
Assess the safety and tolerability of the treatment, with a focus on key adverse events.
Eligible participants will receive CD19 CAR-T cell infusion following a standard lymphodepleting chemotherapy regimen. After infusion, patients will be closely monitored for both short-term and long-term outcomes. Safety Considerations:
Patients will be closely monitored for treatment-related toxicities. Early intervention strategies for CRS and neurotoxicity will be implemented as per established management guidelines. Supportive care, including corticosteroids and anti-cytokine therapies, will be available for severe toxicities.
This study seeks to provide valuable clinical evidence regarding the use of CD19 CAR-T cell therapy as a consolidation strategy for B-ALL patients who are not candidates for HSCT. By evaluating both efficacy and safety parameters, the study aims to contribute to the growing body of knowledge surrounding CAR-T therapies in hematologic malignancies.
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?: