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

Description

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).

Conditions

Breast Cancer, Relapse, Resistant Cancer, Triple Negative Breast Cancer

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Study Overview

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Study Details

Study overview

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).

Study of Administration of T Cells Expressing B7-H3 Specific Chimeric Antigen Receptors and Containing the Inducible Caspase 9 Safety Switch in Subjects With Triple Negative Breast Cancer

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

Condition
Breast Cancer
Intervention / Treatment

-

Contacts and Locations

Chapel Hill

University of North Carolina, Chapel Hill, North Carolina, United States, 27599

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility 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
  • 1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
  • 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

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

UNC Lineberger Comprehensive Cancer Center,

Claire E Dees, MD, MSc, PRINCIPAL_INVESTIGATOR, UNC Lineberger Comprehensive Cancer Center

Study Record Dates

2028-05