NCT07072494

CD19 CAR-T Cell Infusion as Consolidation Therapy in Adolescent and Adult Patients With Acute B-ALL Ineligible for Allogeneic HSCT: A Clinical Study

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
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 30 (estimated)
• Sponsor: Zhujiang Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 80 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Acute Lymphoblastic Leukemia

Interventions

Type	Name	Description
DRUG	CD19 CAR-T cells injection	Lymphodepleting pre-treatment will begin one week before the CAR-T cell infusion to reduce the burden of abnormal immune cells in the body, creating a favorable environment for the infused CAR-T cells. The suggested pre-treatment regimen is based on the FC regimen (Fludarabine + Cyclophosphamide).After the pre-treatment, patients will undergo CAR-T cell infusion, where the genetically modified T-cells are infused back into the patient's body.

Timeline

• Start date: 2025-07-19
• Primary completion: 2027-03-19
• Completion: 2027-08-19
• First posted: 2025-07-18
• Last updated: 2025-07-18

Locations

2 sites across 1 country: China