Trials / Recruiting
RecruitingNCT05210907
Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
A Phase Ib, Clinical Trial of Hospital-manufactured CD19 Chimeric Antigen Receptor T Cells (SNUH-CD19-CAR-T) in Children and Adolescents With Relapsed or Refractory CD19 Positive Acute Lymphoblastic Leukemia
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 5 (estimated)
- Sponsor
- Seoul National University Hospital · Academic / Other
- Sex
- All
- Age
- 0 Years – 25 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | SNUH-CD19-CAR-T | SNUH-CD19-CAR-T is an autologous CAR-T from T cells collected from each patient. Administer a single dose of SNUH-CD19-CAR-T to patients with relapsed or refractory CD19 positive B-cell acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion. |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2025-09-30
- Completion
- 2026-08-31
- First posted
- 2022-01-27
- Last updated
- 2023-02-06
Locations
1 site across 1 country: South Korea
Source: ClinicalTrials.gov record NCT05210907. Inclusion in this directory is not an endorsement.