Basic Information

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

GTO ID GTC1467
Trial ID NCT02030847
Disease B-Cell Adult Acute Lymphocytic Leukemia
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment tisagenlecleucel|CTL019
Generation2nd
PhasePhase2
Recruitment statusCompleted
TitleStudy of Redirected Autologous T Cells Engineered to Contain Anti-CD19 Attached to TCR and 4-1BB Signaling Domains in Patients With Chemotherapy Resistant or Refractory Acute Lymphoblastic Leukemia
Year2014
CountryUnited States
Company sponsorUniversity of Pennsylvania
Other ID(s)UPCC 21413, 818626
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted gene4-1BB; CD3ζ; anti-CD19 scFv
Vector production methodPeripheral blood T cells for manufacturing were collected from patients by leukapheresis and stimulated with beads coated with antibodies directed against CD3 and CD28. Cells were transduced with a lentiviral vector that encoded anti-CD19 scFv linked to 4-1BB and CD3ζ signaling domains.

Clinical Result

Cohort 1
Administration route intravenous infusion
Dosage 1~5E8 cells, 10% on Day 1, 30% on Day 2, 60% on Day 3
Donor type Autologous
Pts 35
Age Adult, Older_Adult
Outcome 24/35(CR). The high-dose fractionated (HDF) cohort had the highest survival, with a 2-year overall survival of 73% (95% CI, 46% to 88%) and event-free survival of 49.5% (95% CI, 21% to 73%).
References PMID: 31815579

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