Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
NCT ID: NCT06305299
Last Updated: 2025-09-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE1
27 participants
INTERVENTIONAL
2024-07-29
2026-03-31
Brief Summary
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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.
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Detailed Description
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Subjects will receive standard-of-care therapy e.g., chemotherapy or radiation therapy to stabilize their disease if the treating physician feels it is in the subject's best interests before the cell therapy.
Subjects with ≥ grade 4 Cytokine Release Syndrome (CRS) or Immune Effector Cell-Associated Neurotoxicity Syndrome (ICANS) or grade 3 CRS or ICANS that do not improve to grade 0-1 within 72 hours will be given a 0.4mg/kg of rimiducid. Furthermore, subjects who experience a ≥ Grade 3 non-hematologic or hematologic toxicity (Excluding Grade 3 electrolyte abnormalities, hyperglycemia, diarrhea, or nausea and vomiting and Grade 3-4 hematologic toxicity without functional sequelae that do not persist at Grade 3-5 for \> 7 days) felt to be secondary to iC9-CAR.B7-H3 may be given rimiducid (0.4 mg/kg).
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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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.
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.
Interventions
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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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
FEMALE
No
Sponsors
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UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Linda Van Le, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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Lineberger Comprehensive Cancer Center
Chapel Hill, North Carolina, United States
Countries
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Central Contacts
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Facility Contacts
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Related Links
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University of North Carolina Lineberger Comprehensive Cancer Center Clinical Trials
Other Identifiers
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LCCC2152-ATL
Identifier Type: -
Identifier Source: org_study_id
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