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

  • STATUS
    Recruiting
  • End date
    Aug 31, 2026
  • participants needed
    5
  • sponsor
    Seoul National University Hospital
Updated on 14 March 2022

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.

Details
Condition B-cell Acute Lymphoblastic Leukemia
Treatment SNUH-CD19-CAR-T
Clinical Study IdentifierNCT05210907
SponsorSeoul National University Hospital
Last Modified on14 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

\. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining informed consent
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

Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians
Known human immunodeficiency virus (HIV) infection
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
Pregnant or nursing (lactating) women
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