Cellular Immunotherapy for Ovarian Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new treatment called Innocell Autologous Cellular Immunotherapy for women with recurrent ovarian cancer. The main goal is to assess the treatment's safety and the immune system's response. This trial targets women with a confirmed diagnosis of advanced epithelial ovarian cancer who have previously undergone treatments like chemotherapy and require a new option. Participants must have at least two measurable or detectable cancer areas. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new therapy.
Will I have to stop taking my current medications?
The trial requires that you stop taking systemic steroids or any other immunosuppressive therapy at least 14 days before starting the treatment. If you're on any other approved systemic therapy, you need to stop it 3 weeks before starting the trial.
Is there any evidence suggesting that Innocell Autologous Cellular Immunotherapy is likely to be safe for humans?
Research shows that Innocell Autologous Cellular Immunotherapy is being tested for safety in people with recurring epithelial ovarian cancer. As this trial is in its early stages, the primary goal is to assess how well participants tolerate the treatment and identify any side effects.
Although no previous human trials have provided safety data for Innocell, the FDA's approval for human testing indicates promise in earlier lab and animal studies. This suggests that major safety concerns were likely addressed before the trial began.
Researchers will closely monitor participants for any negative reactions or side effects to ensure their safety.12345Why do researchers think this study treatment might be promising?
Unlike the standard treatments for ovarian cancer, which often involve surgery and chemotherapy, Innocell Autologous Cellular Immunotherapy uses a unique approach by harnessing the body's own immune cells. Researchers are excited about this treatment because it involves engineering a patient's immune cells to better recognize and attack cancer cells, potentially leading to a more targeted and effective response. Additionally, the use of the CpG 1018 adjuvant in conjunction with this therapy may enhance the immune system's ability to fight the cancer more aggressively. This personalized approach could offer new hope for patients who have limited options with traditional therapies.
What evidence suggests that Innocell Autologous Cellular Immunotherapy might be an effective treatment for ovarian cancer?
Research has shown that Innocell Autologous Cellular Immunotherapy, which participants in this trial will receive, might be promising for treating recurring ovarian cancer. In earlier studies, combining this treatment with another drug led to better results than using the other drug alone, with a 31.4% response rate compared to 12.2%. This suggests that Innocell might help the immune system fight cancer more effectively. Although data remains limited, early results offer hope for improving treatment outcomes in ovarian cancer.12367
Are You a Good Fit for This Trial?
This trial is for patients with recurrent epithelial ovarian cancer, including those with primary peritoneal or fallopian tube cancer. Participants must have measurable disease and be in good physical condition (ECOG PS 0-1). They should have recovered from previous treatment side effects and meet specific blood count criteria. There's no limit on prior treatments but they must have had a recurrence within 6 months after platinum chemotherapy or cannot receive more of it.Inclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Tissue Procurement and Manufacturing
Participants undergo biopsy for tissue procurement to manufacture Innocell vaccine
Treatment
Innocell vaccine administration with CpG 1018 adjuvant via intradermal injection every 2 weeks for 3 doses
Follow-up
Participants are monitored for safety and effectiveness after treatment, with blood drawn for evaluation
Long-term Follow-up
Participants are monitored for clinical response every 3 months for 1 year
What Are the Treatments Tested in This Trial?
Interventions
- Innocell Autologous Cellular Immunotherapy
Trial Overview
The trial is testing the safety and immune response to Innocell Autologous Cellular Immunotherapy in patients with recurrent epithelial ovarian cancer. The therapy uses the patient's own cells, which are modified outside the body and then reintroduced as a form of personalized treatment.
How Is the Trial Designed?
1
Treatment groups
Experimental Treatment
Innocell autologous immunotherapy will be administered with CpG 1018 adjuvant
Find a Clinic Near You
Who Is Running the Clinical Trial?
PhotonPharma, Inc.
Lead Sponsor
Citations
NCT06366490 | Safety and Immunogenicity of Innocell ...
This is a Phase 1, open-label, single-center, pilot study of Innocell autologous cellular immunotherapy (i.e., Innocell vaccine) in patients with recurrent ...
Safety and Immunogenicity of Innocell Autologous Cellular ...
This is a Phase 1, open-label, single-center, pilot study of Innocell autologous cellular immunotherapy (i.e., Innocell vaccine) in patients ...
Immunotherapy in Recurrent Ovarian Cancer
The results showed that the combination treatment was more effective than nivolumab alone (ORR 31.4% vs. 12.2%) [27], with a near doubling of ...
PhotonPharma Inc. Announces Recruitment for Phase 1 ...
The Phase 1 study will assess the safety, tolerability, and immunogenicity of Innocell™ in patients with recurrent epithelial ovarian cancer.
Safety and Immunogenicity of Innocell Autologous Cellular ...
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 ...
PhotonPharma Inc. Announces Recruitment for Phase 1 ...
The Phase 1 study will assess the safety, tolerability, and immunogenicity of Innocell™ in patients with recurrent epithelial ovarian cancer.
7.
targetedonc.com
targetedonc.com/view/fda-clears-clinical-study-of-vaccine-therapy-for-ovarian-cancerFDA Clears Clinical Study of Vaccine Therapy for Ovarian ...
The first-in-human study that has received FDA clearance will investigate the novel autologous Innocell vaccine in stage III/IV ovarian cancer.
Unbiased Results
We believe in providing patients with all the options.
Your Data Stays Your Data
We only share your information with the clinical trials you're trying to access.
Verified Trials Only
All of our trials are run by licensed doctors, researchers, and healthcare companies.