RecruitingPhase 1Phase 2NCT07072494

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

Sponsor

Zhujiang Hospital

Enrollment

30 participants

Start Date

Jul 19, 2025

Study Type

INTERVENTIONAL

Conditions

Acute Lymphoblastic Leukemia

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.

Eligibility

Min Age: 14 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests CD19 CAR-T cell therapy (immune cells engineered to target the CD19 protein on leukemia cells) as a consolidation treatment — given after achieving remission — in adolescents and adults with B-cell acute lymphoblastic leukemia (B-ALL) who cannot undergo a bone marrow transplant. The goal is to help maintain remission without transplant. **You may be eligible if...** - You have been diagnosed with B-cell acute lymphoblastic leukemia (B-ALL), including newly diagnosed or relapsed/refractory disease - You are considered ineligible for a bone marrow/stem cell transplant - You agree to participate and can follow the study schedule **You may NOT be eligible if...** - You are eligible for and can tolerate a bone marrow transplant - You have serious organ problems or active severe infections - Your leukemia does not express CD19 Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGCD19 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.

Locations(2)

Zhujiang Hospital

Guangzhou, Guangdong, China

Zhujiang Hospital

Guangzhou, Guangdong, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07072494

Related Trials

A Study to Evaluate Next-Generation Sequencing (NGS) Testing and Monitoring of B-cell Recovery to Guide Management Following Chimeric Antigen Receptor T-cell (CART) Induced Remission in Children and Young Adults With B Lineage Acute Lymphoblastic Leu...

NCT056212918 locations

CD22 CAR T-cells to Extend Remission Following Commercial CD19 CAR T-cells in Children, Adolescents, and Adults With Relapsed/Refractory B-cell Acute Lymphoblastic Leukemia

NCT073285031 location

Using Text Messages to Improve Oral Chemotherapy for Adolescents and Adults With Acute Lymphoblastic Leukemia

NCT064466611 location

A Study to Learn More About the Study Medicine Called Inotuzumab Ozogamicin (InO) in Children (1 to <18 Years) With First Relapse ALL

NCT0574817174 locations

CD19/CD22 Bicistronic Chimeric Antigen Receptor (CAR) T Cells in Children and Young Adults With Recurrent or Refractory B Cell Malignancies

NCT054425151 location