RECRUITING

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

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Conditions

Breast CancerRelapseResistant CancerTriple Negative Breast Cancercellular therapybiologic therapy

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

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).

Official Title

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

Quick Facts

Study Start:2024-06-27
Study Completion:2028-05
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06347068

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.

Ages Eligible for Study:18 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. 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. 2. Age ≥ 18 years at the time of consent.
  3. 3. Karnofsky score of \> 60% (see APPENDIX VI- Karnofsky Scale))
  4. 4. Histologically confirmed TNBC (ER-, PR-, HER2-negative)
  5. 1. ER- and PR-negative: defined as \< 1% staining by immunohistochemistry (IHC)
  6. 2. HER2-negative: defined as IHC 0-1+ or fluorescence in situ hybridization (FISH) ratio \< 2.0
  1. 1. Patients with a history of symptomatic CNS involvement or multiple metastases requiring whole-brain radiation.
  2. 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. 3. Subject does not have a measurable and or evaluable disease as defined by RECIST 1.1

Contacts and Locations

Study Contact

Caroline Babinec
CONTACT
919-445-4208
UNCImmunotherapy@med.unc.edu
Catherine Cheng
CONTACT
+1 919-445-4208
UNCImmunotherapy@med.unc.edu

Principal Investigator

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

Study Locations (Sites)

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

Collaborators and Investigators

Sponsor: UNC Lineberger Comprehensive Cancer Center

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

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-06-27
Study Completion Date2028-05

Study Record Updates

Study Start Date2024-06-27
Study Completion Date2028-05

Terms related to this study

Keywords Provided by Researchers

  • cellular therapy
  • biologic therapy

Additional Relevant MeSH Terms

  • Breast Cancer
  • Relapse
  • Resistant Cancer
  • Triple Negative Breast Cancer