Treatment of CD19 Chimeric Antigen Receptor T Cells for Pediatric Patients With CD19-positive B-cell Acute Lymphoblastic Leukemia Who Are Indicated for Hematopoietic Stem Cell Transplantation

Launched by SEOUL NATIONAL UNIVERSITY HOSPITAL · Feb 6, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment called CD19 CAR-T therapy for children and young adults with a specific type of leukemia known as CD19-positive B-cell acute lymphoblastic leukemia (B-ALL). The goal is to see if this therapy can be a good alternative to a procedure called hematopoietic stem cell transplantation, which is often needed for patients with very high-risk leukemia. The trial is open to patients aged 25 and younger who have been diagnosed with B-ALL and have already undergone some form of chemotherapy.

To be eligible for the trial, participants must have certain characteristics, such as showing signs of leukemia that expresses a protein called CD19. They also need to have reached a stage called complete remission, meaning that their bone marrow has very few cancer cells after treatment. Participants will receive the CAR-T therapy, which involves using their own modified immune cells to fight the cancer. It's important to note that this trial is still recruiting participants, and some individuals, like those who have already had stem cell transplants or have certain infections, may not qualify. Overall, this trial seeks to offer hope for young patients facing very challenging leukemia cases.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Subject eligibility criteria include individuals who are under the age of 25 at the time of SNUH-CD19-CAR-T administration. Confirmation of B-cell acute lymphoblastic leukemia diagnosed at the initial assessment by a treating physician for the first diagnosis is required. Immunophenotypic analysis of CD19 expression on leukemia cells must be confirmed through immune profiling at the time of the initial diagnosis of B-cell acute lymphoblastic leukemia. In patients experiencing hematologic relapse of B-cell acute lymphoblastic leukemia, CD19 expression should also be confirmed at the time of relapse confirmation.
• Patients must achieve hematologic complete remission defined as less than 5% blasts in the bone marrow after the first-line or second-line chemotherapy (first salvage therapy). Eligible patients for hematopoietic stem cell transplantation, defined by indications for transplantation, include those meeting at least one of the following criteria:
• • 1. Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
• • 2. Hypodiploidy defined by fewer than 44 chromosomes.
• • 3. E2A-HLF gene fusion due to t(17;19) translocation.
• • 4. Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy.
• • 5. Failure of the first-line therapy.
• • 6. Cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment.
• Exclusion Criteria:
• • Patients who have undergone hematopoietic stem cell transplantation.
• • Individuals for whom an adequate or sufficient leukapheresis product suitable for the production of SNUH-CD19-CAR-T cannot be obtained or is unavailable.
• • Those known to be infected with the human immunodeficiency virus (HIV).
• • Presence of uncontrolled active infections, determined by the investigator's assessment. If appropriate treatment has been administered for the infection, and there are no signs of progression at the time of enrollment, it is considered controlled. Persistent fever without other symptoms is not interpreted as progressive infection.
• • Women who are pregnant or breastfeeding.
• • Individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.