NCT06305299 Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
| NCT ID | NCT06305299 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | UNC Lineberger Comprehensive Cancer Center |
| Condition | Ovary Neoplasm |
| Study Type | INTERVENTIONAL |
| Enrollment | 27 participants |
| Start Date | 2024-07-29 |
| Primary Completion | 2036-04 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 27 participants in total. It began in 2024-07-29 with a primary completion date of 2036-04.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.
Eligibility 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.
Contact & Investigator
Linda Van Le, MD
PRINCIPAL INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Frequently Asked Questions
Who can join the NCT06305299 clinical trial?
This trial is open to female participants only, aged 18 Years or older, studying Ovary Neoplasm. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06305299 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06305299 currently recruiting?
Yes, NCT06305299 is actively recruiting participants. Contact the research team at UNCImmunotherapy@med.unc.edu for enrollment information.
Where is the NCT06305299 trial being conducted?
This trial is being conducted at Chapel Hill, United States.
Who is sponsoring the NCT06305299 clinical trial?
NCT06305299 is sponsored by UNC Lineberger Comprehensive Cancer Center. The principal investigator is Linda Van Le, MD at UNC Lineberger Comprehensive Cancer Center. The trial plans to enroll 27 participants.