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

Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer

This is a Phase 1, open-label, multi-center, feasibility study of Innocell autologous cellular immunotherapy (i.e., Innocell vaccine) in patients with recurrent EOC.

The study is a 2-part design. For each participant, Part 1 will involve tissue procurement and confirmation of the ability to manufacture the Innocell vaccine, followed by Part 2 which is the treatment phase, involving Innocell administration to patients.

Part 1 - Tissue Procurement and Manufacturing of Innocell Vaccine

Participants will be screened to assure they fulfill the enrollment criteria. Screening must be performed within 30 days of administration of the Innocell regimen. Patients will undergo biopsy of the tumor. The team will target to harvest 1.0 gram or greater of tissue for the manufacturing process to produce 3 doses of Innocell and overage for testing. Upon successful manufacture and release testing, the Innocell vaccine series will be initiated.

Part 2 - Innocell Administration and Follow-up

Participants will undergo a Baseline Visit to confirm they meet the enrollment criteria. The Baseline Visit must be performed within 30 days of planned initiation of the Innocell vaccine series. The vaccine series will consist of Innocell 1.0 x 106 cells combined with 3 mg CpG 1018 adjuvant via intradermal (ID) injection every 2 weeks (14 ± 3 days) x 3 doses.

Participants will be monitored for a minimum of 60 minutes following each injection, with a follow up visit 2 days (+2 days) post-each injection for evaluation of safety and tolerability. All participants who received at least 1 dose of Innocell will be followed for safety through a minimum of 30 days (+ 7 days) after the last dose of Innocell or until all treatment-related adverse events are resolved or returned to Baseline/Grade 1, whichever is longer, or until the Investigator determines the outcome will not change with further followup.

Blood will be drawn for evaluation of immune response and disease burden prior to each dose of Innocell, and 8 weeks post-initiation of the Innocell vaccine series.

Eligibility Criteria:
Inclusion Criteria:

- Subjects meeting all of the following are eligible for the study:

1. Age ≥ 18 years and female;
2. Patients with histologically or cytologically confirmed, epithelial ovarian, primary peritoneal or fallopian tube cancer who experienced recurrence or progression within 6 months of completion of platinum based chemotherapy, or unable to receive further platinum based chemotherapy. No restriction on prior lines of therapy.
3. 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;
4. Eastern Collaborative Oncology Group (ECOG) performance status (PS) 0-1;
5. Recovery from clinically relevant toxicities to Grade 2 or less (except alopecia, peripheral neuropathy, and ototoxicity);
6. Adequate hematological, hepatic, and renal function as defined by the following laboratory values (obtained ≤ 28 days prior to planned initiation of vaccine series) a. Absolute neutrophil count \>1,000/mm3 b. Absolute lymphocyte count ≥200/mm3 c. Platelets ≥75,000/mm3 d. Hemoglobin ≥9.0 g/dL; low hemoglobin counts may be corrected with transfusion to achieve eligibility for study e. Total bilirubin ≤2 mg/dL f. Serum ALT/AST \<3 times the upper limit of normal g. Serum creatinine ≤1.6 mg/dL or calculated creatinine clearance (CrCL)

   * 50 mL/min as calculated by the Cockcroft-Gault formula.
7. Negative pregnancy test for women of childbearing potential and agree to practice a medically acceptable contraception regimen throughout the participation in the clinical trial. Women who are postmenopausal for at least 1 year (\> 12 months since last menses) or are surgically sterilized do not require this test; and,
8. Provide written informed consent for study participation.

Exclusion Criteria:

* Subjects meeting any of the following are not eligible for the study:

  1. Positive clinical history of human immunodeficiency virus (HIV), hepatitis C virus (HCV), hepatitis B virus (HBV), Human T-lymphotropic virus 1 \& 2 (HTLV-1/2);
  2. Diagnosis of immunodeficiency, either primary or acquired;
  3. 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.4. 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.

  5. Has any acute infection that requires specific therapy. Acute therapy must be completed at least 7 days prior to initiation of Innocell series; 6. 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 Coronavirus Disease - 2019 (COVID-19) are allowed and must be given in accordance with the prevailing immunization guidelines; or 7. Has received any other investigational agents within 4 weeks of planned vaccine initiation.

  8. 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; 9. 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 10. Inability of the subject to comply with study procedures and/or followup