Treatment of B-cell Acute Lymphoblastic Leukemia in Children and Adolescents with CAR-T Cells

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

This study is testing a new CAR-T cell treatment for children and teenagers with hard-to-treat B-cell leukemia to see if it is safe and effective.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 5 (estimated)
• Ages: 0 Years to 25 Years
• Sex: All
• Sponsor: Seoul National University Hospital (Academic / other)
• Drugs / interventions: chemotherapy, CAR-T, Chimeric antigen receptor
• Locations: 1 site (Seoul)
• Trial ID: NCT05210907 on ClinicalTrials.gov

What this trial studies

This clinical study focuses on the production and evaluation of CD19 CAR-T cells, specifically designed for children and adolescents suffering from relapsed or refractory B-cell acute lymphoblastic leukemia. The CAR-T cells are manufactured at the investigational site, Seoul National University Hospital, and the study aims to assess both the safety and efficacy of this treatment approach. Participants will undergo treatment with SNUH-CD19-CAR-T cells, which are engineered to target CD19 positive leukemia cells. The study is in Phase 1, indicating an initial exploration of the treatment's safety profile.

Who should consider this trial

Good fit: Ideal candidates for this study are children and adolescents under 26 years old with relapsed or refractory CD19 positive acute lymphoblastic leukemia.

Not a fit: Patients with uncontrolled infections or other severe comorbidities may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for children and adolescents with limited treatment alternatives for their leukemia.

How similar studies have performed: Other studies utilizing CAR-T cell therapy have shown promising results in treating hematological malignancies, indicating a potential for success in this approach.

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.

Where this trial is running

Seoul

• Seoul National University Hospital — Seoul, South Korea (Recruiting)

Study contacts

• Study coordinator: Hyoungjin Kang, PhD

Conditions B-cell Acute Lymphoblastic Leukemia