Basic Information

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

GTO ID GTC1726
Trial ID NCT03144583
Disease Lymphoma | Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment ARI-0001|Axi-cel|YesCAR-Ta|Axicabtagene Ciloleucel
Generation2nd
PhasePhase1
Recruitment statusActive, Not Recruiting
TitlePilot Study on the Infusion of ARI-0001 Cells in Patients With CD19+ Leukemia or Lymphoma Refractory to Therapy
Year2017
CountrySpain
Company sponsorInstituto de Salud Carlos III
Other ID(s)CART19-BE-01
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted genetransmembrane CD8 domain; 4-1BB costimulatory domain; CD3z signaling domain
Vector production methodARI-0001 cells were manufactured using the CliniMACS Prodigy system (Miltenyi). Approximately 100 × 106 T cells were stimulated to expand with anti-CD3 and anti-CD28 antibodies together with IL-7 and IL-15. 24 h after T cell activation, cells were transduced with a lentiviral vector containing the CAR gene construct at a multiplicity of infection of 10. Following expansion, that lasted from 7 to 10 days, the final ARI-0001 cell product was washed, cryopreserved, and tested for identity, potency, sterility, and adventitious agents.

Clinical Result

Cohort 1
Administration route intravenous infusion
Dosage 0.5~10E6 cells/kg
Donor type Autologous
Pts 50
Age Child, Adult, Older_Adult
Lymph depletion Yes
References PMID: 33010231

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