Basic Information

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

GTO ID GTC0312
Trial ID NCT02772198
Disease Non-Hodgkin's Lymphoma | Acute Lymphoblastic Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment CD19 CAR-T cells
Generation2nd
PhasePhase1|Phase2
Recruitment statusUnknown
TitleT-cells Expressing Anti-CD19 CAR in Pediatric and Young Adults With B-cell Malignancies
Year2016
CountryIsrael
Company sponsorSheba Medical Center
Other ID(s)SHEBA-15-2076-AT-CTIL
Vector information
Vectorretrovirus
ConstructscFv-CD28-CD3ζ
Vector typegammaretrovirus vector
Transgene/Inserted genescFv derived from the mouse anti-CD19 hybridoma; domains from human CD28 and CD3-ζ
Vector production methodFresh leukapheresis product was used for CD19 CAR-T cell production. Peripheral blood monuclear cells (PBMC) were isolated from the apheresis product by density gradient with Ficoll-Hypaque. 60×10e6 cells were transduced with the CD19 CAR retroviral vector and the rest were discarded.

Clinical Result

Cohort 1
Administration route infusion
Dosage 1E6 cells/kg
Donor type Autologous
Pts 73
Age Child, Adult
Lymph depletion Yes
Outcome 27/72(CR); 18/72(PR); 27/72(SD+PD)
Adverse reactions 7/73(cytokine release syndrome), 16/73(immune effector cell-associated neurotoxicity syndrome)
References PMID: 35218999

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