Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
NCT ID: NCT06347068
Last Updated: 2025-09-16
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
42 participants
INTERVENTIONAL
2024-06-27
2028-05-31
Brief Summary
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Detailed Description
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Subjects with TNBC who meet procurement eligibility criteria will have cells collected to manufacture iC9-CAR.B7-H3 T cells. Eligible subjects will receive lymphodepletion with cyclophosphamide and fludarabine.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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iC9-CAR.B7-H3 T cells
Specimen 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 Cell Therapy
iC9-CAR.B7-H3 T cells will then be administered intravenously
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 Cell Therapy
iC9-CAR.B7-H3 T cells will then be administered intravenously
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
1. 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 or legally authorized representative.
2. Age ≥ 18 years at the time of consent.
3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)
1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
Exclusion Criteria
2. 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.
3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1
18 Years
ALL
No
Sponsors
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National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
UNC Lineberger Comprehensive Cancer Center
OTHER
Responsible Party
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Principal Investigators
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Yara E Abdou, MD
Role: PRINCIPAL_INVESTIGATOR
UNC Lineberger Comprehensive Cancer Center
Locations
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University of North Carolina
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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LCCC2128-ATL
Identifier Type: -
Identifier Source: org_study_id
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