Using modified T cells to treat recurrent ovarian cancer
Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors (CAR) and Containing the Inducible Caspase 9 Safety Switch in Subjects With Recurrent Platinum Resistant Epithelial Ovarian Cancer
This study is testing a new treatment using modified immune cells to see if it can help people with recurrent ovarian cancer that hasn't responded to standard treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 27 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | UNC Lineberger Comprehensive Cancer Center Academic / other |
| Drugs / interventions | chemotherapy, chimeric antigen receptor, CAR-T, radiation |
| Locations | 1 site (Chapel Hill, North Carolina) |
| Trial ID | NCT06305299 on ClinicalTrials.gov |
What this trial studies
This phase 1 clinical trial aims to evaluate the safety and tolerability of autologous T lymphocyte chimeric antigen receptor cells targeting the B7-H3 antigen in patients with recurrent platinum-resistant epithelial ovarian cancer. The study involves two parts: first, collecting and modifying T cells from the patient's blood to create iC9-CAR.B7-H3 T cells, and second, administering these modified cells after lymphodepletion chemotherapy. The trial will utilize a dose escalation approach to determine the maximum tolerated dose and establish a recommended phase 2 dose based on safety data.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 and older with histologically confirmed recurrent platinum-resistant or platinum-refractory epithelial ovarian cancer.
Not a fit: Patients with non-epithelial ovarian cancers or those who have not progressed on platinum-based chemotherapy may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with recurrent ovarian cancer who have limited treatment choices.
How similar studies have performed: Other studies using CAR-T cell therapies have shown promise in various cancers, suggesting potential for success with this novel approach in ovarian cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Unless otherwise noted, subjects must meet all of the following criteria to participate in all phases of the study: 2. Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information explained to, understood by and signed by the subject. 3. Age ≥ 18 years at the time of consent. 4. Eastern Cooperative Oncology Group (ECOG) of 0-2. 5. The subject must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological diagnosis of a high-grade serous histology based on local histopathological findings. 6. Subject must have recurrent platinum-resistant or platinum-refractory disease defined as: A disease that has progressed by imagining while receiving platinum OR Disease that has recurred within 6 months of the last receipt of platinum-based chemotherapy. Rising CA-125 only is not considered as platinum-resistant or refractory disease. 7. Having received at least 2 prior regimens (including front-line therapy). Exclusion Criteria: 1. Subjects with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or efficacy assessment of the investigational regimen are eligible for this trial. 2. The subject is not willing and not able to comply with study procedures based on the judgment of the investigator or protocol designee. 10\. The subject is not willing to undergo a biopsy prior to treatment, after infusion, and at the time of disease progression ), and the tumor is determined to be safe by the treating investigator for biopsy collection.
Where this trial is running
Chapel Hill, North Carolina
- Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Linda Van Le, MD — UNC Lineberger Comprehensive Cancer Center
- Study coordinator: Catherine Cheng
- Email: UNCImmunotherapy@med.unc.edu
- Phone: 919-445-4208
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.