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RECRUITINGPhase 1INTERVENTIONAL

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

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 1\. Relapsed or refractory CD19 Positive Acute Lymphoblastic Leukemia. All subjects must be younger than 26 years old at the time of obtaining willing to sign a consent form 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 Who Should NOT Join This Trial: 1. Evidence of uncontrolled hepatitis B virus (HBV) or hepatitis C virus (HCV) based on assessment done by treating physicians. 2. Known human weakened immune system 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. Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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.

Treatments Being Tested

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.

Locations (1)

Seoul National University Hospital
Seoul, South Korea