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DRUG:

KITE-439

i
Other names: KITE-439, KITE 439, HPV16 E7 T cell receptor engineered T cells, E7 T-cell receptor (TCR) T cells
Associations
Trials
Company:
Fosun Pharma, Gilead, National Institutes of Health
Drug class:
HPV-16 E7 protein inhibitor
Associations
Trials
9d
A phase 1 trial of HPV16 E7 T-cell receptor-engineered T cells in patients with relapsed/refractory HPV16-positive cancers (KITE-439 trial). (PubMed, Front Oncol)
Patients received lymphodepleting chemotherapy (cyclophosphamide 30 mg/kg/day for 2 days and fludarabine 25 mg/m2/day for 5 days) followed by a single infusion of KITE-439 with daily IL-2 (2.5×105 IU/kg, up to 7 doses). These results suggest that KITE-439 has an acceptable safety profile for the treatment of patients with HPV-associated epithelial cancers. Further studies are needed to determine optimal manufacturing conditions and T-cell characteristics required for enhanced antitumor activity.
P1 data • Journal
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CD8 (cluster of differentiation 8) • HLA-A (Major Histocompatibility Complex, Class I, A) • CD4 (CD4 Molecule) • IL2 (Interleukin 2) • IL7 (Interleukin 7)
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cyclophosphamide • fludarabine IV • KITE-439
2years
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov)
P2, N=700, Enrolling by invitation, Kite, A Gilead Company | Trial completion date: Mar 2041 --> Dec 2040 | Trial primary completion date: Mar 2041 --> Dec 2040
Trial completion date • Trial primary completion date
|
Yescarta (axicabtagene ciloleucel) • Tecartus (brexucabtagene autoleucel) • KITE-222 • KITE-363 • KITE-439 • KITE-585 • KITE-718
almost3years
Long-term Follow-up Study for Participants of Kite-Sponsored Interventional Studies Treated With Gene-Modified Cells (clinicaltrials.gov)
P2, N=700, Enrolling by invitation, Kite, A Gilead Company | Trial completion date: Nov 2026 --> Mar 2041 | Trial primary completion date: Nov 2026 --> Mar 2041
Trial completion date • Trial primary completion date
|
Yescarta (axicabtagene ciloleucel) • Tecartus (brexucabtagene autoleucel) • KITE-222 • KITE-363 • KITE-439 • KITE-585 • KITE-718