Innocell — a vaccine made from your own tumor for recurrent epithelial ovarian cancer

Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer

This study will test whether a personalized vaccine made from a patient's own tumor cells (Innocell) is safe and triggers an immune response in people with recurrent epithelial ovarian cancer.

Quick facts

• Phase: Phase 1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years and up
• Sex: Female
• Sponsor: PhotonPharma, Inc. (Industry-sponsored)
• Drugs / interventions: bevacizumab, Immunotherapy
• Locations: 1 site (Duarte, California)
• Trial ID: NCT06366490 on ClinicalTrials.gov

What this trial studies

This is a Phase 1, open-label, single-center pilot study that collects tumor tissue to manufacture an individualized Innocell vaccine and then gives that vaccine back to participants. The study has two parts: a biopsy and manufacturing phase to obtain at least 1.0 gram of tumor tissue and produce three vaccine doses, followed by a treatment phase with intradermal Innocell plus CpG 1018 adjuvant given every two weeks for three doses. Participants are monitored on-site for immediate reactions and have brief follow-up visits after each injection for safety and immune monitoring. The trial is conducted at City of Hope in Duarte, California.

Who should consider this trial

Good fit: Adults (female) with recurrent epithelial ovarian, fallopian tube, or primary peritoneal cancer who have received at least one line of platinum-based therapy, have measurable disease at two or more sites, and have ECOG performance status 0–2 are the intended participants.

Not a fit: Patients who cannot provide sufficient tumor tissue for vaccine manufacture, have excluded histologies such as carcinosarcoma, or have very poor performance status or rapidly progressive disease are unlikely to benefit from this trial.

Why it matters

Potential benefit: If successful, Innocell could help stimulate a patient's immune system to recognize and attack ovarian cancer cells and potentially slow disease progression.

How similar studies have performed: Autologous tumor-cell vaccines and other personalized cell-based immunotherapies have induced immune responses in small early-phase studies, but they have not yet shown consistent, large-scale clinical benefit in ovarian cancer.

Eligibility criteria

Inclusion Criteria:

1. Age ≥ 18 years and female;
2. 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;
3. 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);
4. Documented relapse or progression on or after the most recent line of therapy;
5. 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;
6. Eastern Collaborative Oncology Group (ECOG) performance status (PS) 0-2;
7. Recovery from clinically relevant toxicities to Grade 2 or less (except alopecia, peripheral neuropathy, and ototoxicity);
8. Adequate hematological, hepatic, and renal function obtained ≤ 28 days prior to planned initiation of vaccine series
9. 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,
10. Provide written informed consent for study participation.

Exclusion Criteria:

1. Positive clinical history of HIV, HCV, HBV, 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 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. Hs received treatment with an approved systemic therapy within 3 weeks of planned vaccine initiation;
9. 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;
10. 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
11. Inability of the subject to comply with study procedures and/or followup.

Where this trial is running

Duarte, California

• City of Hope — Duarte, California, United States (Recruiting)

Study contacts

• Study coordinator: Beth Crump, RN, BSN

Conditions Ovarian Cancer; Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer; Autologous vaccine; Autologous Cellular Immunotherapy