Recruiting
Phase 1

iC9-CAR.B7-H3

Sponsor:

UNC Lineberger Comprehensive Cancer Center

Code:

NCT06305299

Conditions

Ovary Neoplasm

Ovarian Cancer

Epithelial Ovarian Cancer

Recurrent

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

Interventions

iC9-CAR.B7-H3 T cells

Cyclophosphamide

Fludarabine

Study Details

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.

Conditions

Ovary Neoplasm

Ovarian Cancer

Epithelial Ovarian Cancer

Recurrent

Study ID

NCT06305299

Start date

Jul 29, 2024

Status verified date

May, 2026

Completion date

Apr, 2036

Anticipated

Primary completion date

Apr, 2036

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 18+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

27 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Chimeric Antigen Receptors

blood will be collected to prepare the iC9-CAR.B7-H3 T cells. Disease-fighting T cells will be isolated and modified to prepare the iC9-CAR.B7-H3 T cells. In part 2, the iC9-CAR.B7-H3 T cells are given by infusion after completion of lymphodepletion chemotherapy.

Interventions

iC9-CAR.B7-H3 T cells

iC9-CAR.B7-H3 T cells will then be administered intraperitoneally

Cyclophosphamide

cyclophosphamide 300 mg/m2 IV will be given.

Fludarabine

fludarabine 30 mg/m2 IV will be given.

Primary outcome measure

  • Toxicity: NCI-CTCAE [ Time Frame: Up to 4 weeks ]
  • Toxicity: Cytokine Release Syndrome (CRS) [ Time Frame: Up to 4 weeks ]
  • Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS) [ Time Frame: Up to 4 weeks ]

Central Contacts and Locations

Central contacts

Locations

Lineberger Comprehensive Cancer Center

Recruiting

Chapel Hill, North Carolina, United States, 27599

Contacts

Principal Investigator:

Linda Van Le

More Information

Sponsor

UNC Lineberger Comprehensive Cancer Center

Last update posted

May 19, 2026

Last verified

May, 2026

Keywords

  • cellular therapy
  • biologic therapy
  • Platinum Resistant

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by UNC Lineberger Comprehensive Cancer Center on 2026-05-19.