Table II.
Published clinical trials on adoptive EBV-CTL immunotherapy for NPC.
| Author, year | Design | Treatment | Sample size | Condition | Efficacy | Safety | (Refs.) |
|---|---|---|---|---|---|---|---|
| Chua, 2001 | Pilot | EBV-specific CTLs | 4 | R/M EBV+ NPC | 3 EBV burden decrease; 3 died of PD (9-21 months after EBV-CTLs) | No ≥G3 toxicity | (90) |
| Comoli, 2004 | Preliminary | EBV-specific CTLs | 1 | Relapsed EBV+ NPC | SD | Temporary worsening of local tumor symptoms | (91) |
| Straathof, 2005 | Phase I | EBV-specific CTLs | 10 | Stage III/IV EBV+ NPC in remission or with R/R history | 4 pts with previous remission remain disease-free, DFS: 19-27 months; 6 pts with previous R/R NPC: 2 CR; 1 PR; 1 SD; 2 no response | 1 pts: Tumor swelling requiring tracheostomy | (92) |
| Comoli, 2005 | Phase I | EBV-specific CTLs | 10 | Stage IV EBV+ NPC | 2 PR; 4 SD; 4 PD | 2 pts: Inflammatory reaction at tumor sites | (93) |
| Louis, 2010 | Phase I/II | EBV-specific CTLs | 23 | R/R EBV+ NPC | 5 remain in remission; 3 recurrent disease; 3 CR; 2 CRu; 2 PR; 3 SD; 5 PD | 1 pts: Tumor swelling requiring tracheostomyp | (94) |
| Lutzky, 2014 | Preliminary | EBV-specific CTLs | 1 | R/M EBV+ NPC | PR | No ≥G3 toxicity | (95) |
| Eom, 2016 | Phase I | EBV/LMP2A-specific CD8+ T cells (EBViNT) | 4 | R/R EBV+ NPC | 3 PD at week 4; 1 SD at week 4, but PD at week 8 | No ≥G3 toxicity | (96) |
| Louis, 2009 | Phase I | Anti-CD45 mAb followed by EBV-specific CTLs | 8 | R/M EBV+ NPC | 1 CR; 2 SD; 5 PD | 1 pts: Transient lymph node swelling | (97) |
| Secondino, 2012 | Phase II | Fludarabine-cyclophosphamide followed by EBV-specific CTLs | 11 | Stage IV, EBV+ NPC | 2 PR; 4 SD; 5 PD | 4 pts: G3 neutropenia; 2 pts: Tumor swelling | (98) |
| Smith, 2012 | Phase I | EBV-specific CTLs | 14 | R/M EBV+ NPC | 10 SD; mPFS: 4.5 months; median OS: 17.4 months | No ≥G3 toxicity | (99) |
| Smith, 2017 | Phase II | AdE1-LMPpoly vector-based CTLs | 29 | 9 pts: no or minimal residual NPC (N/MRD) 20 pts: active R/M NPC (ARMD) | N/MRD: 6 maintain response; 3 PD; ARMD: 12 SD; 8 PD; All: mPFS: 5.5 months; median OS: 38.1 months | 2 pts: G3 lung abscess | (100) |
| Huang, 2017 | Phase I/II | EBV-specific CTLs | 21 | R/M EBV+ NPC | 1 CR; 2 SD; 18 PD; (mPFS: 2.2 months; median OS: 16.7 months) | No ≥G3 toxicity | (101) |
| Chia, 2014 | Phase II | Gemcitabine-carboplatin followed by EBV-specific CTLs | 38 | R/M EBV+ NPC | 3 CR; 22 PR; 11 SD; 1 PD; 1 NA; (3-year OS 37.1%) | No ≥G3 toxicity | (102) |
NPC, nasopharyngeal carcinoma; EBV, Epstein-Barr virus; CTL, cytotoxic T-lymphocytes; LMP, latent membrane protein; mAb, monoclonal antibody; R/M, recurrent/metastatic; R/R, relapsed/refractory; pts, patients; PD, progressive disease; SD, static disease; CR, complete response; PR, partial response; CRu, unconfirmed complete response; NA, not assessed; DFS, disease-free survival; OS, overall survival; mPFS, median progression-free survival; G3, grade 3.