Table 1 Clinical Trials of adoptive immunotherapy in ovarian cancer
Sponsor | ID | Condition | Type of immunotherapy | Primary outcome | Secondary outcome | Status |
|---|---|---|---|---|---|---|
University Healt Network of Toronto | NCT01883297 | Recurrent, Platinum Resistant High Grade Serous Ovarian, Fallopian Tube, or Primary Peritoneal Cancer | Re-stimulated tumor-infiltrating lymphocytes (TILs) | Number occurrences and severity of side effects | Clinical response to treatment Number of patients with an immunity and no immunity to the study treatment | Recruiting |
National Cancer Institute | NCT01174121 | Metastatic cancer (digestive tract, urothelial, breast, ovarian/endometrial) | Re-stimulated tumor-infiltrating lymphocytes (TILs) | determine the ability of autologous TIL to mediate tumor regression | / | Recruiting |
Harlev Hospital | NCT02482090 | Metastatic Ovarian Cancer | Re-stimulated tumor-infiltrating lymphocytes (TILs) | Determine the safety of the administration of TIL therapy including lymphodepleting chemotherapy and Interleukin-2 for patients with metastatic Ovarian Cancer | Tumor related immunoresponses ORR OS PFS | Recruiting |
Mie University | NCT02096614 | Solid tumors (melanoma, head and neck cancer, ovarian cancer, esophageal cancer) | MAGE-A4 Specific TCR Gene Transferred T Lymphocytes | Confirm the toxicity profile Confirm no replication competent retrovirus observed Confirm no clonality is observed Evaluate persistence and expansion of transferred TBI-1301 | / | Recruiting |
Mie University | NCT02366546 | Solid tumors (melanoma, head and neck cancer, ovarian cancer, synovial sarcoma, esophageal cancer) | NY-ESO-1-specific TCR gene transduced T lymphocytes | Toxicity profile confirmation Confirm no replication competent retrovirus observed Confirm no clonality is observed Evaluate persistence and expansion of transferred TBI-1301 | / | Recruiting |
Memorial Sloan Kettering Cancer Center | NCT00562640 | Fallopian Tube, Ovarian, Primary Peritoneal Cancer | Wilms’ tumor gene (WT1) peptide sensitized autologous T cells | Safety and tolerability Mean tolerated dose of autologous WT1 peptide-specific T cells Quantitation of alterations in the concentration of peptide-specific T cells in the blood at defined intervals post infusion Effects of the adoptively transferred T cells on the growth and progression of cancer | / | Active, not recruiting |
Fred Hutchinson Cancer Research Center | NCT00101257 | Advanced ovarian cancer | Autologous CD4+ Antigen Specific T Cell Clones | • Safety and toxicity of autologous CD4-positive antigen-specific T cells • Determine the duration of in vivo persistence of this drug in these patients. | • Determine the antitumor effect of this drug in these patients. | Completed |
Abramson Cancer Center of the University of Pennsylvania | NCT01312376 | Recurrent Ovarian Fallopian Tube or Primary Peritoneal Cancer | Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Combined With Vaccine Boost and Bevacizumab | • determine the feasibility and safety | / | Completed |
Abramson Cancer Center of the University of Pennsylvania | NCT02277392 | Recurrent Ovarian Carcinoma, Fallopian Tube or Primary Peritoneal Cancer | Recombinant Human Interleukin-18 (Sb-485232) Combined With Adoptive Transfer of Vaccine-Primed CD3/CD28-Costimulated Autologous T-Cells Following Lymphodepletion | • determine the feasibility and safety | / | Completed |
Fred Hutchinson Cancer Research Center | NCT00003887 | Breast Cancer, Chronic Myeloproliferative Disorders, Gestational Trophoblastic Tumor, Kidney Cancer, Leukemia, Lymphoma Multiple Myeloma and Plasma Cell Neoplasm, Myelodysplastic Syndromes, Neuroblastoma, Ovarian Carcinoma, Sarcoma Testicular Germ Cell Tumor | peripheral blood lymphocyte therapy | • Determine the feasibility of donor lymphocyte infusion as adoptive immunotherapy | / | Completed |
Cancer Research UK | NCT01212887 | Breast Cancer, Colorectal Cancer, Gastric Cancer, Lung Cancer, Ovarian Cancer, Pancreatic Cancer, Unspecified Adult Solid Tumor, Protocol Specific | MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes, aldesleukin, cyclophosphamide and fludarabine phosphate | evaluate the feasibility assess the toxicity of this regimen in these patients. determine the dose required to give optimal survival of these cells in the circulation (recommended phase II dose). | assess whether MFE23 scFv-expressing autologous anti-CEA MFEz T lymphocytes isolated from the circulation are functional. determine the preliminary tumor response evaluate the safety | Terminated |
University of Washington | NCT00228358 | HER2-positive Breast Cancer, Recurrent Breast Cancer, Recurrent Non-small Cell Lung Cancer Recurrent Ovarian, Epithelial Cancer, Recurrent Ovarian Germ Cell Tumor, Stage IV Breast Cancer, Stage IV Non-small Cell Lung Cancer, Stage IV Ovarian Epithelial Cancer, Stage IV Ovarian Germ Cell Tumor | ex vivo-expanded HER2-specific T cells | • Feasibility and Safety of infusing HER2 specific T cells | Number of patients in whom the precursor frequency of antigen specific T cells is increased by 10-fold over baseline within one week after the last infusion Number of patients in whom an immune response is demonstrated if baseline immune response was below detection • HER2 specific CD4+ or CD8+ precursor frequencies • Anti-tumor effects of HER2 specific T cells • Persistence of T cell immune augmentation in vivo after adoptive transfer of HER2 specific T cells | Completed |
Adaptimune | NCT01567891 | Recurrent Ovarian Epithelial cancer | Citoreductive surgery followed by infusion with NYESO-1(C259) transduced autologous T cells. | To determine the safety and tolerability of autologous redirected T cell therapy | Tumor Response | Recruiting |