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

Plain-language summary

The purpose of this Phase 1 study is to manufacture CD19-directed CAR-T cells (SNUH-CD19-CAR-T) at the investigational site and to evaluate their safety and efficacy in children and adolescents with relapsed/refractory B-cell acute lymphoblastic leukemia (ALL). Chimeric antigen receptor T cells have been developed to treat relapsed and refractory hematological malignancies, with promising outcomes reported in patients with very poor prognosis. Eligibility requires relapsed or refractory CD19-positive ALL and an age under 26 at consent, with a second or greater bone marrow relapse or any bone marrow relapse after allogeneic stem cell transplant.

The summary above is a plain-language rendering of the official record. The original English title is shown for reference.

Trial details

Phase

Phase 1

Status

Recruiting

Sponsor

Seoul National University Hospital

Intervention

SNUH-CD19-CAR-T

Start date

2/15/2022

Estimated completion

8/31/2026

Countries

South Korea

Locations

• Seoul, South Korea

Eligibility criteria

Criteria are reproduced from the ClinicalTrials.gov record in the original English. Only the trial team can determine 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.