NCT05210907 Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
| NCT ID | NCT05210907 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Seoul National University Hospital |
| Condition | B-cell Acute Lymphoblastic Leukemia |
| Study Type | INTERVENTIONAL |
| Enrollment | 5 participants |
| Start Date | 2022-02-15 |
| Primary Completion | 2025-09-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 5 participants in total. It began in 2022-02-15 with a primary completion date of 2025-09-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 1\. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent a. 2nd or greater BM\[bone marrow\] relapse OR b. Any BM relapse after allogeneic SCT\[stem cell transplant\] and must be ≥ 6 months from SCT at the time of SNUH\_CD19\_CAR-T infusion OR c .Refractory as defined by not achieving a CR after 2 cycles of a standard chemotherapy regimen or chemorefractory as defined by not achieving a CR after 1 cycle of standard chemotherapy for relapsed leukemia OR d. Ineligible for allogeneic SCT because of: * 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 years) or Lansky (age \< 16 years) performance status ≥ 50 at screening Exclusion Criteria: 1. Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians. 2. Known human immunodeficiency virus (HIV) infection. 3. Presence of clinically active uncontrolled infection based on assessment done by treating physicians. Infections are considered controlled if appropriate therapy has been instituted and, at the time of screening, no signs of progression are present. Persisting fever without other signs or symptoms will not be interpreted as progressing infection. 4. Pregnant or nursing (lactating) women.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT05210907 clinical trial?
This trial is open to participants of all sexes, aged 0 Years or older, up to 25 Years, studying B-cell Acute Lymphoblastic Leukemia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05210907 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05210907 currently recruiting?
Yes, NCT05210907 is actively recruiting participants. Contact the research team at kanghj@snu.ac.kr for enrollment information.
Where is the NCT05210907 trial being conducted?
This trial is being conducted at Seoul, South Korea.
Who is sponsoring the NCT05210907 clinical trial?
NCT05210907 is sponsored by Seoul National University Hospital. The trial plans to enroll 5 participants.
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