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New treatment option for Very High Risk Acute Lymphoblastic Leukemia
Official title 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
ClinicalTrials.gov ID: NCT06247501
What this study is testing
What is SNUH-CD19-CAR-T?
SNUH-CD19-CAR-T is an investigational medicine, being studied as a potential treatment for very high risk acute lymphoblastic leukemia.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a phase 2 clinical trial targeting pediatric and adolescent patients diagnosed with CD19-positive B-ALL, considered very high-risk group. The study aims to administer CD19 CAR-T therapy as an alternative to hematopoietic stem cell transplantation in patients eligible for such transplantation.
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages up to 25
You may be able to join if
- 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...
- Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
- Hypodiploidy defined by fewer than 44 chromosomes.
- E2A-HLF gene fusion due to t(17;19) translocation.
- Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and...
You likely can't join if
- 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...
- 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...
- Women who are pregnant or breastfeeding.
- Individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.
See the full eligibility 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...
- Philadelphia chromosome-positive due to t(9;22)(q34;q11) translocation.
- Hypodiploidy defined by fewer than 44 chromosomes.
- E2A-HLF gene fusion due to t(17;19) translocation.
- Detection of minimal residual disease (MRD) positive at 0.01% or higher by next-generation sequencing confirmed after consolidation therapy and maintenance therapy.
- Failure of the first-line therapy.
- Cases not meeting any of the above criteria but deemed eligible for hematopoietic stem cell transplantation based on the investigator's judgment.
- 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...
- Women who are pregnant or breastfeeding.
- Individuals deemed clinically inappropriate for participation in the clinical trial based on the investigator's clinical judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Seoul, South Korea
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, up to 25 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Seoul, South Korea. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.