Table 6.
Ongoing clinical trials of EBV-CTLs in NPC.
| Trial | Status | Design | Estimated enrollment | Disease status | Therapy lines | Treatment | Primary endpoint | Completion date |
|---|---|---|---|---|---|---|---|---|
|
NCT02578641 VANCE |
Ongoing | Phase III | 330 | R/M non-keratinizing and undifferentiated EBV (+) NPC | 1 | GC-CTL versus GC | Prolonging OS | January 2023 |
|
NCT00953420 CADEN |
Completed | Phase II | 20 | R/R EBV (+) NPC | ⩾2 | EBV-CTL following docetaxel–carboplatin–dexamethasone CT | ORR | July 2015 |
| NCT02065362 | Not recruiting | Phase I | 14 | R/R EBV (+) NPC | ⩾2 | DNR.NPC-specific T-cells versus DNR.NPC-specific T-cells + cyclophosphamide + fludarabine | Safety | Feburary 2033 |
|
NCT00706316 NPC-CTL |
Completed | Phase I | 5 | R/M EBV (+) NPC | ⩾2 | EBV-Specific CTLs + CD45 Mab | Safety | November 2012 |
|
NCT00516087 NATELLA |
Completed | Phase I | 23 | R/R or high risk (T3 or T4, or node positive disease) EBV (+) NPC | ⩾2 | LMP1- and LMP2-specific CTLs | Safety | July 2013 |
|
NCT00078546 CLANC |
Completed | Phase I | 12 | R/R EBV (+) NPC | ⩾2 | EBV-specific CTL Infusion following anti-CD45 monoclonal antibody | Safety | April 2007 |
|
NCT02287311 MABEL |
Recruiting | Phase I | 42 | EBV (+) lymphoma and other malignancies (including EBV (+) NPC) | ⩾2 | MABEL CTLs | Safety | August 2021 |
| NCT03769467 | Completed | Phase Ib/2 | 12 | R/M EBV (+) NPC | ⩾2 | Tabelecleucel + pembrolizumab | Safety | January 2020 |
|
NCT01447056 MALTED |
Completed | Phase I | 37 | Relapsed EBV-associated diseases | ⩾2 | LMP-specific T-cells | Safety | January 2023 |
CT, chemotherapy; CTL, cytotoxic T-cell; DNR, dominant negative receptor; EBV, Epstein–Barr virus; GC, gemcitabine and carboplatin; Mab, monoclonal antibody; MABEL, LMP, BARF-1 and EBNA1; N/A, not available; NPC, nasopharyngeal carcinoma; ORR, objective response rate; OS, overall survival; R/M, recurrent/metastatic; R/R, refractory or relapsed; Ref., reference.