Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer

Korábbi kezelés

• Active or prior history of autoimmune disease;
  • Note: The following conditions are permitted (i.e., not exclusionary) if the condition does not require immunosuppressive treatment:
  • Type 1 diabetes (if stable, well controlled, and not brittle); Vitiligo; Hypo- or hyperthyroid disease; or Autoimmune alopecia.
• Treatment with systemic steroids or any other form of immunosuppressive therapy within 14 days prior to planned initiation of the Innocell vaccine; Note: Inhaled or topical steroids, including mouthwash, and adrenal replacement doses are permitted in the absence of active autoimmune disease.
• Has any acute infection that requires specific therapy. Acute therapy must be completed at least 7 days prior to initiation of Innocell series;
• Has received any live or attenuated vaccines against infectious diseases within 28 days of the planned vaccine initiation. Inactive vaccines, including SARS-CoV-2 vaccines authorized for use for active immunization to prevent COVID-19 are allowed and must be given in accordance with the prevailing immunization guidelines; or
• Has received any other investigational agents within 4 weeks of planned vaccine initiation.
• Hs received treatment with an approved systemic therapy within 3 weeks of planned vaccine initiation;

Más betegség

• Positive clinical history of HIV, HCV, HBV, HTLV-1/2;
• Prior malignancy, except those that were treated curatively and have not recurred within 5 years prior to study treatment; resected basal cell and squamous cell skin cancers;

Laborértékek

• History or current evidence of any condition, therapy, or laboratory abnormality, or other circumstance that might confound the results of the study or interfere with the patient's participation for the full duration of the study, such that it is not in the best interest of the patient to participate, in the opinion of the treating investigator; or

Egyéb

• Diagnosis of immunodeficiency, either primary or acquired;
• Inability of the subject to comply with study procedures and/or followup.

• Age ≥ 18 years and female;
• Has histologically or cytologically confirmed diagnosis of advanced epithelial ovarian cancer (except carcinosarcoma), primary peritoneal, or fallopian tube cancer that has received at least 1 line of platinum-based systemic therapy and for whom single-agent therapy is appropriate as the next line of treatment;
• Been treated with available standard-of-care therapy likely to convey clinical benefit (i.e., PARP inhibitors for women with germline BRCA mutation and in homologous recombination repair deficiency based on prior molecular testing or bevacizumab as appropriate);
• Documented relapse or progression on or after the most recent line of therapy;
• Patients must have at least 2 sites of measurable or detectable disease. The team will target to collect 1.0 gram of tumor tissue that can be removed and be available for manufacturing;
• Eastern Collaborative Oncology Group (ECOG) performance status (PS) 0-2;
• Recovery from clinically relevant toxicities to Grade 2 or less (except alopecia, peripheral neuropathy, and ototoxicity);
• Adequate hematological, hepatic, and renal function obtained ≤ 28 days prior to planned initiation of vaccine series
• Negative pregnancy test for women of childbearing potential and agree to practice a medically acceptable contraception regimen throughout the participation in the clinical trial; and,
• Provide written informed consent for study participation.