Clinical Study of Hospital-manufactured CD19 CAR-T in Children and Adolescents With Acute Lymphoblastic Leukemia
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: SNUH-CD19-CAR-T.
- Who it may be relevant to
- Registry conditions: B-cell Acute Lymphoblastic Leukemia. Basic parameters: 0 years — 25 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- South Korea
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
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
Overview
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.
Interventions
- Biological SNUH-CD19-CAR-T
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 acute lymphoblastic leukemia, and evaluate safety and efficacy of SNUH-CD19-CAR-T for 12 months after the infusion.
Primary outcome measures
- Incidence of adverse events and its severity [Time frame: 12 months post SNUH-CD19-CAR-T infusion]
Secondary outcome measures (2)
- Patients with CR[complete remission] after Hospital-manufactured CAR-T infusion [Time frame: 1 month post SNUH-CD19-CAR-T infusion]
- Overall survival and event-free survival [Time frame: 12 months post SNUH-CD19-CAR-T infusion]
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
- 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.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
South Korea · 1 center
- Seoul National University Hospital — Seoul
Identifiers
NCT: NCT05210907 · SNUH_CART_CD19ALL