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RecruitingPhase 1

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years and older
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Procedures mentioned: Infusions

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The data from the dose escalation will be used to determine a recommended phase 2 dose (RP2D), which will be decided based on the maximum tolerated dose (MTD) and additional factors such as the ability to manufacture sufficient cells for infusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This phase 1 study tests the safety of increasing doses of CAR-T cells made from a person's own immune cells and changed to target B7-H3. It is for adults with triple-negative breast cancer that has come back or has not responded to treatment.

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).

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be at least 18 years old.
  • You or your legal representative must understand and sign consent and permission to share personal health information.
  • Have a Karnofsky score above 60%, a measure of how well you can do daily activities.
  • Have triple-negative breast cancer confirmed by tissue tests. The cancer must meet the study's limits for three markers: ER, PR, and HER2.
  • The listing says people with another past or current cancer are eligible, even if that cancer or its treatment could affect study safety or results.

Who can't join

  • Have a history of cancer affecting the brain or spinal cord that caused symptoms, or several areas of cancer spread that need radiation to the whole brain.
  • Have no cancer that can be measured or assessed using the study's standard rules.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: Unless otherwise noted, subjects must meet all of the following criteria to participate in in all phases of the study: 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: 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

Study sites (1)

NC