Items | Singapore trial |
---|---|
Characteristics | |
Phase | 2 |
Key eligibility criteria | Treatment-naïve recurrent/metastatic EBV-positive NPC |
Experimental regimen | Chemotherapy+EBV-CTLs: Gemcitabine 1000 mg/m2, and carboplatin (AUC 2) (days 1, 8 and 15) q4wks for 4 cycles, followed by EBV-CTL 1 × 108 cells/m2 on weeks 0, 2, 8, 16, 24, and 32 |
Sample size | 35 |
Clinical endpoints | |
Median follow-up, months | 29.9 |
ORR (%) | 71.5 |
CR (%) | 8.6 |
PR (%) | 62.9 |
SD (%) | 28.6 |
PD (%) | 0 |
All grade AEs (%) | NR |
Grade 3–5 AEs (%) | NR |
Abbreviations: AUC area under the curve, CR complete response, EBV Epstein-Barr virus, EBV-CTLs EBV-specific cytotoxic T lymphocytes, NPC nasopharyngeal carcinoma, NR not reported, ORR objective response rate, q4wks every 4 weeks, PD progressive disease, PR partial response, SD stable disease