Basic Information

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

GTO ID GTC0484
Trial ID NCT03960840
Disease Diffuse Large B-Cell Lymphoma
Altered gene CD19
Therapeutic/Target gene Target gene
TherapyCAR-T cell
Treatment YTB323|Rapcabtagene Autoleucel
PhasePhase1|Phase2
Recruitment statusRecruiting
TitlePhase I/II Study of Rapcabtagene Autoleucel in CLL, 3L+ DLBCL, ALL and 1L HR LBCL
Year2019
CountryUnited States
Company sponsorNovartis Pharmaceuticals
Other ID(s)CYTB323A12101
Vector information
Vectorlentivirus

Clinical Result

Cohort 1
Administration route intravenous infusion
Dosage 2.5E6 cells, 12.5E6 cells, 25E6 cells, 40E6 cells
Donor type Autologous
Pts 47
Age Adult, Older_Adult
Outcome 65%(CR,DL2).96% of patients reported any-grade adverse events, and 89% had grade ≥3 events. CRS occurred in 33% of patients, managed with tocilizumab, corticosteroids, and vasopressors. ICANS occurred in 11% of patients, with management involving dexamethasone, methylprednisolone, and anakinra.
Adverse reactions All patients reported 1 any-grade adverse event; 96% had ≥1 event of grade ≥3. Sixteen patients(34%) experienced cytokine release syndrome(CRS; 1 grade-4 event). DL2 median time to CRS onset, 8 days(range, 1–17 days); median time to resolution, 6 days(range, 2–25 days).
References DOI: 10.1016/S2152-2650(23)01520-3

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