Using modified T cells to treat recurrent ovarian cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.