Recruiting
Phase 1

Innocell

Sponsor:

PhotonPharma, Inc.

Code:

NCT06366490

Conditions

Ovarian Cancer

Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Innocell Autologous Cellular Immunotherapy

Study Details

Brief summary:

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

Conditions

Ovarian Cancer

Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer

Study ID

NCT06366490

Start date

Feb 12, 2026

Status verified date

Mar, 2026

Completion date

Dec, 2026

Anticipated

Primary completion date

Nov, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

8 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Innocell an Autologous Cellular Immunotherapy

Innocell autologous immunotherapy will be administered with CpG 1018 adjuvant

Interventions

Innocell Autologous Cellular Immunotherapy

Innocell Autologous Cellular Immunotherapy cells will be administered with CpG 1018 adjuvant ID every 2 weeks x 3 doses

Primary outcome measure

  • Success rate of autologous manufacturing [ Time Frame: 2 months ]
  • Safety assessed by treatment emergent adverse events [ Time Frame: From 1st dose of Innocell until 30 days post last dose ]

Central Contacts and Locations

Central contacts

Locations

City of Hope

Recruiting

Duarte, California, United States, 91010

Principal Investigator:

Mihae Song, MD

More Information

Sponsor

PhotonPharma, Inc.

Last update posted

Mar 27, 2026

Last verified

Mar, 2026

Keywords

  • Autologous vaccine
  • Autologous Cellular Immunotherapy

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by PhotonPharma, Inc. on 2026-03-27.