Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia

Phase 1

Recruiting

• Conditions: B-cell Acute Lymphoblastic Leukemia
• Interventions: Biological: SNUH-CD19-CAR-T

• Registration Number: NCT05210907
• Lead Sponsor: Seoul National University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2022-01-14
• Study First Submitted QC: 2022-01-14
• Study First Posted: 2022-01-27
• Study Start: 2022-02-15
• Status Verified: 2023-01
• Last Update Submitted: 2023-02-03
• Last Update Posted: 2023-02-06
• Primary Completion: 2025-09-30
• Study Completion: 2026-08-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 5

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
CD19 CAR-T therapy	SNUH-CD19-CAR-T	SNUH-CD19-CAR-T is administered as an intravenous infusion.

Primary Outcome Measures

Name	Time	Method
Incidence of adverse events and its severity	12 months post SNUH-CD19-CAR-T infusion

Secondary Outcome Measures

Name	Time	Method
Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion	1 month post SNUH-CD19-CAR-T infusion
Overall survival and event-free survival	12 months post SNUH-CD19-CAR-T infusion

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of