Basic Information

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

GTO ID GTC0444
Trial ID NCT03575351
Disease B-Cell Non-Hodgkin's Lymphoma
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment Breyanzi|Lisocabtagene maraleucel|liso-cel|JCAR017
Location approved US, Japan, EU, Switzerland, UK, Canada
Generation2nd
PhasePhase3
Recruitment statusCompleted
TitleA Study to Compare the Efficacy and Safety of JCAR017 to Standard of Care in Adult Subjects With High-risk, Transplant-eligible Relapsed or Refractory Aggressive B-cell Non-Hodgkin Lymphomas (TRANSFORM)
Year2018
CountryUnited States
Company sponsorCelgene
Other ID(s)JCAR017-BCM-003|U1111-1213-1944|2018-000929-32
Vector information
Vectorlentivirus
ConstructscFv-4-1BB-CD3ζ
Transgene/Inserted geneanti‐CD19 single‐chain variable fragment; 4‐1BB costimulatory motif; CD3ζ T‐cell activation domain

Clinical Result

Cohort1: liso-cel
Administration route intravenous infusion
Dosage 1E8 cells
Donor type Autologous
Pts 92
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Median event-free survival:2.3 months [2.2–4.3]
Adverse reactions 1/92(Grade 3 CRS); 4/92(neurological events); no grade 4 or 5 events; 44/92(Serious treatment-emergent adverse events)
References DOI: 10.1016/S0140-6736(22)00662-6
Cohort2: standard-of-care
Administration route intravenous infusion
Donor type Autologous
Pts 92
Age Adult, Older_Adult
Lymph depletion Yes
Outcome Median event-free survival:10.1 months [95% CI 6.2–not reached]
Adverse reactions 44/92(Serious treatment-emergent adverse events)
References DOI: 10.1016/S0140-6736(22)00662-6

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