CAR-T Cells for Ovarian Cancer
Trial Summary
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.
What data supports the effectiveness of the treatment iC9-CAR.B7-H3 T cells for ovarian cancer?
Research shows that CAR-T cells targeting B7-H3 can control the growth of ovarian cancer in lab and animal studies, suggesting they might be effective in treating this cancer. Additionally, B7-H3 is a promising target because it is highly expressed in ovarian cancer cells, which may help overcome resistance to other treatments.12345
Is CAR-T cell therapy targeting B7-H3 safe for humans?
What makes the iC9-CAR.B7-H3 T cell treatment unique for ovarian cancer?
The iC9-CAR.B7-H3 T cell treatment is unique because it targets the B7-H3 protein, which is highly expressed in ovarian cancer cells but not in normal tissues, making it a promising target for immunotherapy. This approach is particularly beneficial for patients who do not respond to traditional PD-1/PD-L1 therapies, as B7-H3 is a different checkpoint molecule involved in suppressing the immune response.13458
What is the purpose of this trial?
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.
Research Team
Linda Van Le
Principal Investigator
UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria
This trial is for individuals with ovarian cancer that has returned after standard treatment. Participants must have sufficient T cells to modify, and meet specific health criteria not detailed here.Inclusion Criteria
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Lymphodepletion Chemotherapy
Subjects receive lymphodepletion chemotherapy prior to CAR-T cell infusion
CAR-T Cell Treatment
iC9-CAR.B7-H3 T cells are infused into subjects after lymphodepletion chemotherapy
Follow-up
Participants are monitored for safety and effectiveness after CAR-T cell treatment
Long-term Follow-up
Participants are monitored for progression-free survival and overall survival
Treatment Details
Interventions
- iC9-CAR.B7-H3 T cells
Find a Clinic Near You
Who Is Running the Clinical Trial?
UNC Lineberger Comprehensive Cancer Center
Lead Sponsor