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New treatment option for B-cell Acute Lymphoblastic Leukemia
Official title Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
ClinicalTrials.gov ID: NCT05210907
What this study is testing
What is SNUH-CD19-CAR-T?
SNUH-CD19-CAR-T is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for b-cell 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
- Chimeric antigen receptor T cells (CAR-T cells) have been developed to treat relapsed and refractory hematological malignancies with promising outcome in patients with very poor prognosis. The purpose of this clinical study is to produce the CD19[cluster of differentiation antigen 19] CAR-T (SNUH-CD19-CAR-T) at the investigational site and to evaluate safety and efficacy of SNUH-CD19-CAR-T in children and adolescent with relapsed/refractory B-cell acute lymphoblastic leukemia.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 0 to 25
You may be able to join if
- 1\. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All people must be younger than 26 years old at the time of obtaining informed...
- Severe comorbid disease
- Other contraindications to allogeneic SCT conditioning regimen
- Lack of suitable donor 2\. Documentation of CD19 tumor expression in bone marrow or peripheral blood by flow cytometry. 3\. Karnofsky (age ≥ 16...
You likely can't join if
- Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians.
- Known human immunodeficiency virus (HIV) infection.
- Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if...
- Pregnant or nursing (lactating) women.
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, 0 years 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.