Ovarian CancerPhase 1NCT06366490
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy for Recurrent Epithelial Ovarian Cancer
A Phase 1 study testing Innocell Autologous Cellular Immunotherapy in people with Ovarian Cancer and Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer, run by PhotonPharma, Inc. at 1 site in United States.
Trial summary
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Ovarian Cancer, Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer
- What is being tested?
- Innocell Autologous Cellular Immunotherapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Feb 2026to Dec 2026
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
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- 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.
Who cannot join
- Positive clinical history of HIV, HCV, HBV, HTLV-1/2;
- Diagnosis of immunodeficiency, either primary or acquired;
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
City of Hope
Duarte, California, 91010
Mihae Song, MD
About this study
Official title: Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
Read the detailed description
This is a Phase 1, open-label, single-center, pilot 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 14 days of planned initiation of the Innocell vaccine series. The vaccine series will consist of Innocell cells combined with 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 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, 2 weeks (+/- 3 days) and 30 (+7) days after the last dose of Innocell.
- Conditions
- Ovarian Cancer, Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer
- Being tested
- Innocell Autologous Cellular Immunotherapy
- Keywords
- Autologous vaccine, Autologous Cellular Immunotherapy
- Medical subject headings
- Ovarian Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Innocell Autologous Cellular ImmunotherapyBiological
Innocell Autologous Cellular Immunotherapy cells will be administered with CpG 1018 adjuvant ID every 2 weeks x 3 doses
| Study group | Role | What they receive |
|---|---|---|
| Innocell an Autologous Cellular Immunotherapy | Experimental | Innocell autologous immunotherapy will be administered with CpG 1018 adjuvant Receives: Biological: Innocell Autologous Cellular Immunotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Success rate of autologous manufacturing
Percent success rate to manufacture Innocell from autologous malignant tissue for patient administration
Measured: 2 months
Safety assessed by treatment emergent adverse events
Proportion of subjects experiencing treatment emergent adverse events
Measured: From 1st dose of Innocell until 30 days post last dose
Secondary outcomes (6)
Immune response to Innocell
Mean change in circulating biomarkers
Measured: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Mean change in circulating cytokine levels
Measured: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Mean change in T-cell counts
Measured: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Determined by > 1.5x over baseline via T-cell activation assay
Measured: Baseline to 30 days post last dose of Innocell
Immunogenicity of Innocell Vaccine
Correlation of % cancer cells in Innocell vaccine to immune response
Measured: Baseline to 30 days post last dose of Innocell
Clinical response
Assessed by RECIST criteria v1.1
Measured: Baseline to 30 days post last dose of Innocell, with long-term FU every 3 months x 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Apr 2024
- Study start12 Feb 2026
- Primary completionNov 2026 (estimated)
- Study completionDec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Ovarian CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- PhotonPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06366490
- Sponsor's protocol ID
- CIP2023-001
- Status last verified
- Mar 2026
- First submitted
- 28 Mar 2024
- Last updated
- 27 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase 1 Study to Assess the Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients With Recurrent Epithelial Ovarian Cancer
- ClinicalTrials.gov ID
- NCT06366490
- Acronym / sponsor ID
- CIP2023-001
- Conditions
- Ovarian Cancer, Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer
- Keywords
- Autologous vaccine, Autologous Cellular Immunotherapy
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- PhotonPharma, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Feb 2026 (actual)
- Primary completion
- Nov 2026 (estimated)
- Study completion
- Dec 2026 (estimated)
- First posted
- 16 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Safety and Immunogenicity of Innocell Autologous Cellular Immunotherapy Administered in Patients with Recurrent Epithelial Ovarian Cancer
Detailed description
This is a Phase 1, open-label, single-center, pilot 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 14 days of planned initiation of the Innocell vaccine series. The vaccine series will consist of Innocell cells combined with 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 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, 2 weeks (+/- 3 days) and 30 (+7) days after the last dose of Innocell.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Innocell an Autologous Cellular Immunotherapy | Experimental | Biological: Innocell Autologous Cellular ImmunotherapyInnocell autologous immunotherapy will be administered with CpG 1018 adjuvant |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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;
Key exclusion criteria (13 listed)
- Positive clinical history of HIV, HCV, HBV, HTLV-1/2;
- Diagnosis of immunodeficiency, either primary or acquired;
- 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:
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Innocell Autologous Cellular ImmunotherapyInnocell Autologous Cellular Immunotherapy cells will be administered with CpG 1018 adjuvant ID every 2 weeks x 3 doses | Biological | Innocell an Autologous Cellular Immunotherapy |
Primary outcome
Success rate of autologous manufacturing
Time frame: 2 months
Percent success rate to manufacture Innocell from autologous malignant tissue for patient administration
Safety assessed by treatment emergent adverse events
Time frame: From 1st dose of Innocell until 30 days post last dose
Proportion of subjects experiencing treatment emergent adverse events
6 secondary outcomes
Immune response to Innocell
Time frame: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Time frame: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Time frame: Baseline to 30 days post last dose of Innocell
Immune response to Innocell
Time frame: Baseline to 30 days post last dose of Innocell
Immunogenicity of Innocell Vaccine
Time frame: Baseline to 30 days post last dose of Innocell
Clinical response
Time frame: Baseline to 30 days post last dose of Innocell, with long-term FU every 3 months x 1 year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Innocell Autologous Cellular Immunotherapy in people with Ovarian Cancer and Recurrent Epithelial Ovarian Cancer Which Includes Epithelial Ovarian, Fallopian Tube and/or Primary Peritoneal Cancer, run by PhotonPharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 27 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Beth Crump, RN, BSN (303-981-1120, beth.crump@photonpharma.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success rate of autologous manufacturing (time frame: 2 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Mar 2026.