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Long-Term Follow-Up in Pediatric and Adolescent with Acute Lymphoblastic Leukemia receiving hospital-manufactured CAR-T

Long-Term Safety and Efficacy Assessment through Longitudinal Follow-Up of Pediatric and Adolescent Patients Receiving SNUH-CD19-CAR-T for CD19-Positive B-Cell Malignancies

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CRIS
Registry ID
KCT0009475
Enrollment
10
Registered
2024-05-29
Start date
2023-06-28
Completion date
Unknown
Last updated
2024-06-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

None listed

Sponsors

Seoul National University Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: - Participants who were enrolled in advanced regenerative medicine clinical trials and received SNUH-CD19-CAR-T therapy : This includes individuals who received SNUH-CD19-CAR-T treatment but, for “any reason”, did not complete the planned schedule of the clinical trial.

Exclusion criteria

Exclusion criteria: Not Applicable

Design outcomes

Primary

MeasureTime frame
the types and frequencies of major adverse reactions;the occurrence of secondary malignancies. Additionally;Detection of Replicant Competent Lentivirus (RCL)—

Secondary

MeasureTime frame
overall reaction;minimal residual disease status in patients achieving complete remission (CR), CR with incomplete hematologic recovery (CRh), or CR with incomplete count recovery (CRi);response duration;relapse-free survival, event-free survival, and overall survival.—

Countries

Korea, Republic of

Contacts

Public ContactHyoungJin Kang

Seoul National University Hospital

01026@snuh.org+82-2-2072-3304

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026