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

Seoul National University

Status and phase: Enrolling; Phase 1

Conditions: B-cell Acute Lymphoblastic Leukemia

Treatments: Biological: SNUH-CD19-CAR-T

Study type: Interventional

Funder types: Other

Identifiers

NCT05210907

SNUH_CART_CD19ALL

Details and patient eligibility

About

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.

Enrollment: 5 estimated patients

Sex: All

Ages: Under 25 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

CD19 CAR-T therapy

Experimental group

Description:

SNUH-CD19-CAR-T is administered as an intravenous infusion.

Treatment:

Biological: SNUH-CD19-CAR-T