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

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

Status

Active, not recruiting

Phases

Phase 1

Study type

Interventional

Source

CRIS

Registry ID

KCT0006957

Enrollment

Registered

2022-01-24

Start date

2022-02-28

Completion date

Unknown

Last updated

2026-01-05

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

Conditions

None listed

Interventions

Genetic : 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 acut

Eligibility

Sex/Gender

All

Inclusion 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 relapse OR b. Any BM relapse after allogeneic SCT 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 chemotherpy 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

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.

Design outcomes

Primary

Measure	Time frame
Incidence of adverse events and its severity	—

Secondary

Measure	Time frame
Patients with CR after Hospital-manufactured CAR-T infusion;Overall survival and event-free survival	—

Countries

Korea, Republic of

Contacts

Public ContactHyoungJin Kang

Seoul National University Hospital

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

Outcome results