RecruitingPhase 1

Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells

United States42 participantsStarted 2024-06-27

Plain-language summary

This phase 1, single-center, open-label study explores the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) cells in subjects with relapsed/refractory triple-negative breast cancer (TNBC).

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. 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.
✓. Age ≥ 18 years at the time of consent.
✓. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
✓. Histologically confirmed TNBC (ER-, PR-, HER2-negative)
✓. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
✓. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0

Exclusion criteria

✕. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
✕. 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.
✕. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1

What they're measuring

Toxicity: NCI-CTCAE

Timeframe: Up to 4 weeks

Toxicity: Cytokine Release Syndrome (CRS)

Timeframe: Up to 8 weeks after infusion of Biological/Vaccine

Toxicity: Immune effector cell-associated neurotoxicity syndrome (ICANS)

Timeframe: Up to 4 weeks

Trial details

NCT IDNCT06347068

SponsorUNC Lineberger Comprehensive Cancer Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2026-05

Contact for this trial

Caroline Babinec

919-445-4208 UNCImmunotherapy@med.unc.edu

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