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New treatment option for Ovary Neoplasm
Official title Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
ClinicalTrials.gov ID: NCT06305299
What this study is testing
What is iC9-CAR.B7-H3 T cells?
iC9-CAR.B7-H3 T cells is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for ovary neoplasm.
Also referred to as iC9-CAR.B7-H3 T.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older, women only
You may be able to join if
- Unless otherwise noted, people must meet all of the following criteria to participate in all phases of the study:
- Written informed consent and Health Insurance Portability and Accountability Act (HIPAA) authorization for release of personal health information...
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) of 0-2.
- The subject must have histologically or cytologically confirmed epithelial ovarian, peritoneal or fallopian tube cancer and must have a histological...
You likely can't join if
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works...
- 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...
See the full eligibility criteria
- Unless otherwise noted, people must meet all of the following criteria to participate in all phases of the study:
- 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.
- Age ≥ 18 years at the time of consent.
- Eastern Cooperative Oncology Group (ECOG) of 0-2.
- 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...
- 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...
- Having received at least 2 prior regimens (including front-line therapy).
- people with a prior or concurrent malignancy whose natural history or treatment has the potential to interfere with the safety or how well it works assessment of the investigational regimen are eligible for this trial.
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Chapel Hill, North Carolina, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Chapel Hill, North Carolina, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.