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

B-cell Acute Lymphoblastic Leukemia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05210907
• Other study ID #: SNUH_CART_CD19ALL
• Status: Recruiting
• Phase: Phase 1
• Start date: February 15, 2022
• Est. completion date: August 31, 2026

Study information

• Verified date: January 2023
• Source: Seoul National University Hospital
• Contact: Hyoungjin Kang, PhD
• Phone: +82-2-2072-3304
• Email: kanghj[@]snu.ac.kr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 5
• Est. completion date: August 31, 2026
• Est. primary completion date: September 30, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 0 Years to 25 Years

Eligibility

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.

Related Conditions & MeSH terms

• B-cell Acute Lymphoblastic Leukemia
• Leukemia
• Leukemia, Lymphoid
• Precursor Cell Lymphoblastic Leukemia-Lymphoma

Intervention

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.

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Incidence of adverse events and its severity		12 months post SNUH-CD19-CAR-T infusion
Secondary	Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion		1 month post SNUH-CD19-CAR-T infusion
Secondary	Overall survival and event-free survival		12 months post SNUH-CD19-CAR-T infusion