Treatment using CAR-T cells targeting B7-H3 for triple-negative breast cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This phase 1, single-center, open-label study investigates the safety of escalating doses of chimeric antigen receptor T cells (CAR-T) targeting the B7-H3 antigen in patients with relapsed or refractory triple-negative breast cancer (TNBC). Eligible participants will undergo lymphodepletion with cyclophosphamide and fludarabine before receiving the experimental iC9-CAR.B7-H3 T cell therapy. The study employs a modified 3+3 design to determine the maximum tolerated dose (MTD) and establish a recommended phase 2 dose (RP2D) based on safety and manufacturing feasibility.

Why it matters

Who can join: the full rules

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

Where it's running

• University of North Carolina
  Chapel Hill, North Carolina, United States Recruiting

Study contacts

• Principal investigator: Yara Abdou, MD — UNC Lineberger Comprehensive Cancer Center
• Study coordinator: Caroline Babinec
• Email: UNCImmunotherapy@med.unc.edu
• Phone: 919-445-4208

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using CAR-T cells to target B7-H3 in pancreatic cancer

  This study is testing a new treatment using specially modified immune cells to see if they can safely help people with pancreatic cancer that has come back after other treatments.

  Recruiting Phase 1 UNC Lineberger Comprehensive Cancer Center · Chapel Hill, North Carolina · NCT06158139

• CAR-T Therapy Safety, Response, and Immune-Escape: Observational Study in Adults

  This observational study looks at adults who receive CAR-T cell therapy or bispecific antibodies to see which factors predict response and immune-related side effects.

  Recruiting IRCCS San Raffaele · Milan, Italy · NCT07915102

• Natalizumab to help prevent brain-related side effects during CAR-T therapy in certain lymphoma patients

  This phase 2 study tests whether natalizumab can reduce severe ICANS in adults with recurrent or refractory DLBCL or MCL receiving CAR-T therapy.

  Recruiting Phase 2 University of Michigan Rogel Cancer Center · Ann Arbor, Michigan · NCT07892027

• CD19 CAR-T Therapy for Kids with Refractory Childhood SLE

  This study tests whether a patient’s own CD19 CAR-T cells can help children and young adults with severe, hard-to-treat lupus.

  Recruiting Phase 1 Seoul National University Hospital · Seoul · NCT07855302

• In Vivo CD19/CD20 CAR T-Cell Therapy for Relapsed or Refractory B-Cell Lymphoma

  This early-phase trial tests a one-time in vivo CAR T-cell therapy (SL1617) for people with relapsed or refractory B-cell lymphoma to see if it is safe and tolerable.

  Recruiting Phase 1 Chinese PLA General Hospital · Beijing · NCT07775508

• Can older adults with breast cancer tolerate a dense CMF chemo schedule

  This study tests whether giving a condensed CMF chemotherapy regimen is feasible for people 70 and older with breast cancer.

  Recruiting at 7 sites Phase 2 Memorial Sloan Kettering Cancer Center · Basking Ridge, New Jersey and 6 other locations · NCT07768436

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.