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

NCT06366490 | Recruiting Phase 1 FDA Drug

• 1 other identifier: CIP2023-001
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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

Keywords

Autologous vaccine; Autologous Cellular Immunotherapy

Outcome Measures

Primary Outcomes (2)

• Success rate of autologous manufacturing

  Percent success rate to manufacture Innocell from autologous malignant tissue for patient administration

  2 months

• Safety assessed by treatment emergent adverse events

  Proportion of subjects experiencing treatment emergent adverse events

  From 1st dose of Innocell until 30 days post last dose

Secondary Outcomes (6)

• Immune response to Innocell

  Baseline to 30 days post last dose of Innocell

• Immune response to Innocell

  Baseline to 30 days post last dose of Innocell

• Immune response to Innocell

  Baseline to 30 days post last dose of Innocell

• Immune response to Innocell

  Baseline to 30 days post last dose of Innocell

• Immunogenicity of Innocell Vaccine

  Baseline to 30 days post last dose of Innocell

Study Arms (1)

Innocell an Autologous Cellular Immunotherapy

EXPERIMENTAL

Innocell autologous immunotherapy will be administered with CpG 1018 adjuvant

Biological: Innocell Autologous Cellular Immunotherapy

Interventions

Innocell Autologous Cellular Immunotherapy BIOLOGICAL

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

Innocell an Autologous Cellular Immunotherapy

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Positive clinical history of HIV, HCV, HBV, HTLV-1/2;
• Diagnosis of immunodeficiency, either primary or acquired;
• Active or prior history of autoimmune disease;
• 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;
• 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;
• 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
• Inability of the subject to comply with study procedures and/or followup.

Sponsors & Collaborators

• PhotonPharma, Inc.: lead

Study Sites (1)

City of Hope

Duarte, California, 91010, United States

RECRUITING

MeSH Terms

Conditions

Ovarian Neoplasms

Condition Hierarchy (Ancestors)

Endocrine Gland Neoplasms; Neoplasms by Site; Neoplasms; Ovarian Diseases; Adnexal Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Neoplasms, Female; Urogenital Neoplasms; Genital Diseases; Endocrine System Diseases; Gonadal Disorders

Central Study Contacts

Beth Crump, RN, BSN

CONTACT

303-981-1120; beth.crump@photonpharma.net

Thomas Bogenrieder, MD, Ph.D.

CONTACT

011 49 2115401040; thomas.bogenrieder@photonpharma.net

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Masking Details: Open label Phase I trial with no masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 28, 2024
• First Posted: April 16, 2024
• Study Start: February 12, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: March 27, 2026

Record last verified: 2026-03

Locations

US (1)