Table 2.
Clinical trials of immune monoclonal antibodies in natural killer/T cell lymphoma
| Targets | Intervention/treatment | Disease | Trial name | Number of enrolled participants | Phase | Status | Trial identifier |
|---|---|---|---|---|---|---|---|
| PD-1 | Pembrolizumab | T cell Lymphoma or NK-Cell Lymphoma | Pembrolizumab for T/NK-cell lymphomas NK-cell Lymphomas | 33 | 2 | Unkonwn | NCT03021057 |
| NKTCL of the nasal cavity/nasopharynx | Study of Pembrolizumab in Patients With Early-Stage NK/T cell Lymphoma, Nasal Type | 19 | 2 | Recruiting | NCT03728972 | ||
| Pembrolizumab | Relapsed/Refractory PCTL include NKTCL | Pembrolizumab and Pralatrexate in Treating Patients With Relapsed or Refractory Peripheral T cell Lymphomas | 40 | 1/2 | Recruiting | NCT03598998 | |
| Pembrolizumab | Natural Killer/T cell Lymphoma, Nasal and Nasal-Type | Treatment of Relapsed or Refractory Natural Killer/T cell Lymphoma | 20 | 2 | Unkonwn | NCT03107962 | |
| Pembrolizumab, Copanlisib | NK and T cell non-Hodgkin’s lymphoma | Study of MK-3475 Alone or in Combination With Copanlisib in Relapsed or Refractory NK and T cell Non-Hodgkin Lymphoma | 19 | 1/2 | Active, not recruiting | NCT02535247 | |
| Tislelizumab | NK/T cell Lymphoma | Dexamethasone, Azacytidine, Pegaspargase and Tislelizumab for NK/T cell Lymphoma | 50 | 2 | Not yet recruiting | NCT04899414 | |
| Early-stage Extranodal NK-T-Cell Lymphoma, Nasal and Nasal-Type | Radiotherapy and Anti-PD-1 in Low-risk ES-ENKTCL | 30 | 2 | Recruiting | NCT05149170 | ||
| Sintilimab | Relapsed/Refractory ENKTL | Efficacy and Safety Evaluation of IBI308 in Patients With Extranodal NK/T cell Lymphoma Patients (ORIENT-4) | 28 | 2 | Completed | NCT03228836 | |
| Sintilimab, P-Gemox | NK/T cell Lymphoma Nos | Sintilimab With P-GemOx Regimen for Newly Diagnosed Advanced Extranodal Natural Killer/T cell Lymphoma, Nasal Type | 63 | 2 | Recruiting | NCT04127227 | |
| Sintilimab, Lenalidomide | NK/T cell Lymphoma Nos | Lenalidomide and Sintilimab for Relapsed/Refractory NK/T cell Lymphoma | 20 | 2 | Recruiting | NCT04231370 | |
| Sintilimab, Chidamide | Relapsed/Refractory ENKTL | Sintilimab in Combination With Chidamide in Refractory and Relapsed ENKTCL | 40 | 1/2 | Completed | NCT03820596 | |
| Sintilimab, Pegaspargase, Anlotinib | Early stage NKTL, nasal and nasal-Type | Combined Treatment of Sintilimab, Peg-aspargase Plus Anlotinib in NK/T cell Lymphoma | 30 | 2 | Recruiting | NCT03936452 | |
| Pegaspargase, Anti-PD-1 monoclonal antibody | ENKTCL, nasal type | Anti-PD-1 Antibody Combined With Pegaspargase in the Treatment of Advanced Stage NK/T cell Lymphoma | 22 | 2 | Recruiting | NCT04096690 | |
| PD-1 antibody, Chidamide, Lenalidomide, Etoposide | NK/T cell Lymphoma | PD-1 Antibody, Chidamide, Lenalidomide and Etoposide for Relapsed or Refractory NK/T cell Lymphoma | 50 | 4 | Unknown | NCT04038411 | |
| Nivolumab | Relapsed/Refractory PTCL | Nivolumab in Treating Patients With Relapsed or Refractory Peripheral T cell Lymphoma | 12 | 2 | Terminated | NCT03075553 | |
| Nivolumab | T cell and NK cell lymphomas, cutaneous squamous cell carcinoma, Merkel cell carcinoma, and other rare skin tumors | Talimogene Laherparepvec and Nivolumab in Treating Patients With Refractory Lymphomas or Advanced or Refractory Non-melanoma Skin Cancers | 68 | 2 | Recruiting | NCT02978625 | |
| SHR-1210 | Relapsed/Refractory ENKTCL, nasal type | SHR-1210 in Patients With Relapsed or Refractory Extranodal NK/T cell Lymphoma | 97 | 2 | Active, not recruiting | NCT03363555 | |
| SHR1210, Apatinib | Relapsed/Refractory NKTCL | PD1 Combined With Apatinib in Patients With Relapsed or Refractory NK/T cell Lymphoma | 61 | 2 | Unknown | NCT03701022 | |
| LEAP regimen (Sintilimab, Pegaspargase, Anlotinib) | Natural Killer/T cell Lymphoma, Nasal and Nasal-Type | Sintilimab, Pegaspargase and Anlotinib for Stage IV Natural Killer/T cell Lymphoma | 37 | 2 | Recruiting | NCT04004572 | |
| Toripalimab | Extranodal NK/T cell Lymphoma, Nasal Type | Maintenance Therapy With Anti-PD-1 Antibody for Patients With NK/T cell Lymphoma | 20 | 2 | Not yet recruiting | NCT04338282 | |
| Toripalimab, P-GemOx, IMRT | Early-Stage ENKTL | A Multicenter, Phase 3, Randomized Trial of Sequencial Chemoradiotherapy With or Without Toripalimab (PD-1 Antibody) in Newly Diagnosed Early-Stage Extranodal Natural Killer/T cell Lymphoma, Nasal Type (ENKTL) | 207 | 3 | Recruiting | NCT04365036 | |
| PD-L1 | Avelumab | Relapsed/Refractory ENKTL | Avelumab in Relapsed or Refractory Extranodal Natural Killer/T cell Lymphoma[AVENT STUDY] | 21 | 2 | Active, not recruiting | NCT03439501 |
| Sugemalimab (CS1001) | Extranodal Natural Killer/T cell Lymphoma | A Study of CS1001 in Subjects With Relapsed or Refractory Extranodal Natural Killer/T cell Lymphoma (ENKTL) | 80 | 2 | Active, not recruiting | NCT03595657 | |
| IMC-001 | Relapsed/Refractory ENKTL | A Study of IMC-001 in Subjects With Relapsed or Refractory Extranodal NK/T cell Lymphoma, Nasal Type | 20 | 2 | Recruiting | NCT04414163 | |
| Sugemalimab | Extranodal NK/T cell Lymphoma | An Expanded Access Program to Provide Sugemalimab for the Treatment of Relapsed or Refractory Extranodal Natural Killer/T cell Lymphoma (R/R ENKTL) | NA | NA | Available | NCT05131438 | |
| CTL-4 | Ipilimumab | Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer, include Adult Nasal Type Extranodal NK/T cell Lymphoma | Ipilimumab and Local Radiation Therapy in Treating Patients With Recurrent Melanoma, Non-Hodgkin Lymphoma, Colon, or Rectal Cancer | 3 | 1/2 | Terminated (Planned Future Study) | NCT01769222 |
| CCR4 | Mogamulizumab (KW-0761) | Peripheral T/NK-cell Lymphoma | Study of KW-0761 in Subjects With CCR4-positive Peripheral T/NK-cell Lymphoma | 38 | 2 | Completed | NCT01192984 |
| KW-0761 | Adult T cell Leukemia and Lymphoma (ATL), Adult Peripheral T cell Lymphoma (PTCL) | Phase I Study of KW-0761 in Relapsed Patients With CCR4-Positive ATL and PTCL | 16 | 1 | Completed | NCT00355472 | |
| CD25 (IL-2Rα) | Basiliximab | Mature T cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Mature T- and NK-Cell Non-Hodgkin Lymphoma, Refractory Mature T cell and NK-Cell Non-Hodgkin Lymphoma, Recurrent Cutaneous T cell Non-Hodgkin Lymphoma, Refractory Cutaneous T cell Non-Hodgkin Lymphoma | Yttrium Y 90 Basiliximab and Combination Chemotherapy Before Stem Cell Transplant in Treating Patients With Mature T cell Non-Hodgkin Lymphoma | 20 | 1 | Active, not recruiting | NCT02342782 |
| Basiliximab, Pegaspargase | Extranodal NK/T cell Lymphoma | Combination of Basiliximab and Pegaspargase in the Treatment of ENKTCL | 20 | 2 | Not yet recruiting | NCT04337593 | |
| CD30 | B-MAD chemotherapy | Extranodal NK/T cell Lymphoma | B-MAD Chemotherapy in Newly-diagnosed Extranodal NK/ T cell Lymphoma | 36 | 1/2 | Active, not recruiting | NCT03246750 |
| Anti-CD30/CD16A Monoclonal Antibody AFM13 | Recurrent or refractory CD30-positive HL or NHL | Modified Immune Cells (AFM13-NK) and A Monoclonal Antibody (AFM13) in Treating Patients With Recurrent or Refractory CD30 Positive Hodgkin or Non-Hodgkin Lymphomas | 30 | 1 | Recruiting | NCT04074746 | |
| AFM 13 | Relapsed/Refractory cutaneous lymphomas | AFM13 in Relapsed/Refractory Cutaneous Lymphomas | 18 | 1/2 | Completed | NCT03192202 | |
| Brentuximab vedotin, Cyclophosphamide, Prednisone, Doxorubicin, Vincristine | Lymphoma, Large-Cell, AnaplasticLymphoma, NK-cellLymphoma, T cell | A Phase 1 Study of Brentuximab Vedotin Given Sequentially and Combined With Multi-Agent Chemotherapy for CD30-Positive Mature T cell and NK-Cell Neoplasms | 39 | 1 | Completed | NCT01309789 | |
| Brentuximab vedotin | Relapsed or Refractory EBV-and CD30-positive Lymphomas | Brentuximab Vedotin in Patients With Relapsed or Refractory EBV-and CD30-positive Lymphomas | 25 | 2 | Completed | NCT02388490 | |
| CD38 | Daratumumab | Relapsed or refractory NKTCL | A Study to Assess the Clinical Efficacy and Safety of Daratumumab in Participants With Relapsed or Refractory Natural Killer/T cell Lymphoma (NKTCL), Nasal Type | 32 | 2 | Completed | NCT02927925 |
| CD52 | Alemtuzumab (Campath), EPOCH | Lymphoma, T-CellLymphoma, Extranodal NK-T-Cell | Campath-1H and EPOCH to Treat Non-Hodgkin’s T- and NK-Cell Lymphomas | 31 | 2 | Completed | NCT00069238 |
| Alemtuzumab, CHOP | T cell LymphomaLymphoma, Non-Hodgkin’s | Study of CHOP + Campath for T cell, Null Cell, or Natural Killer (NK)-Cell Lymphoma | NA | 1 | Completed | NCT00161590 | |
| Alemtuzumab, CHOP | Aggressive T/NK-Cell Lymphomas | CHOP and Campath-1H in Previously Untreated Aggressive T/NK-Cell Lymphomas | 24 | 1 | Completed | NCT00323323 | |
| Alemtuzumab, CHOP-14 | Peripheral T cell Lymphoma, Unspecified Angioimmunoblastic Lymphadenopathy Extranodal NK/T cell Lymphoma | Immunotherapy in Peripheral T cell Lymphoma - the Role of Alemtuzumab in Addition to Dose Dense CHOP (A-CHOP-14) | 274 | 3 | Unknown | NCT00725231 |
NKTCL, natural killer/T cell lymphoma; ENKTL, extranodal NK/T-cell lymphoma, nasal type; R/R, Relapsed/Refractory; PTCL NOS, peripheral T cell lymphoma not otherwise specified; HL, Hodgkin lymphomas; NHL, non-Hodgkin lymphomas; PD-1, programmed death 1; PD-L1, programmed cell death-ligand 1; CTLA-4, cytotoxic T lymphocyte-associated antigen 4; CCR4, C-C chemokine receptor 4; IL-2Rα, IL-2 receptor alpha; ORR, overall response rate; CR, complete response; PR, partial response; SD, stable disease; P-GemOx, pegaspargase, gemcitabine and oxaliplatin; IMRT, intensity-modulated radiotherapy; EPOCH, etoposide, prednisone, vincristine, cyclophosphamide, doxorubicin; CHOP, cyclophosphamide, doxorubicin, vincristine, and prednisone.