Basic Information

Gene symbol CD19 Synonyms B4, CVID3 Type of gene protein-coding
Description CD19 molecule

GTO ID GTC0306
Trial ID NCT02735291
Disease Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19 CAR-T cells
Generation3rd
Recruitment statusActive, Not Recruiting
TitleStudy Evaluating the Efficacy and Safety With CAR-T for Recurrent or Refractory Acute Non T Lymphocyte Leukemia
Year2015
CountryChina
Company sponsorSinobioway Cell Therapy Co., Ltd.
Other ID(s)42156
Vector information
Vectorretrovirus
ConstructscFv-CD28-4-1BB-CD3ζ
Transgene/Inserted geneCD19-specific scFv; hIgG4-CH2CH3; CD28TM (transmembrane domain); CD137 (4-1BB) co-stimulatory domain; intracellular signaling domain of CD3ξ

Clinical Result

Cohort 1
Administration route infusion
Dosage 1~5E6 cells/kg
Donor type Autologous
Pts 47
Age Child, Adult, Older_Adult
Lymph depletion Yes
Outcome 38/47(CR). The overall survival (OS) and relapse-free survival (RFS) rates at 1 year are 53.0% and 45.0%, respectively.
Adverse reactions 11/47(cytokine release syndrome); 1/47(immune effector cell-associated neurotoxicity syndrome); 2/47(ALT/AST increased); 1/47(Hypokalemia)
References PMID: 33230103

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