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Trial Title:
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
NCT ID:
NCT06347068
Condition:
Breast Cancer
Relapse
Resistant Cancer
Triple Negative Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms
Cyclophosphamide
Fludarabine
Fludarabine phosphate
Conditions: Keywords:
cellular therapy
biologic therapy
Study type:
Interventional
Study phase:
Phase 1
Overall status:
Recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Biological
Intervention name:
iC9-CAR.B7-H3 T Cell Therapy
Description:
iC9-CAR.B7-H3 T cells will then be administered intravenously
Arm group label:
iC9-CAR.B7-H3 T cells
Other name:
iC9-CAR.B7-H3 T cells
Intervention type:
Drug
Intervention name:
cyclophosphamide
Description:
cyclophosphamide 300 mg/m2 IV will be given.
Arm group label:
iC9-CAR.B7-H3 T cells
Other name:
Cytoxan
Intervention type:
Drug
Intervention name:
fludarabine
Description:
fludarabine 30 mg/m2 IV will be given.
Arm group label:
iC9-CAR.B7-H3 T cells
Other name:
Fludara
Other name:
Fludarabine Phosphate
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).
Detailed description:
T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T
cells) treatment is experimental and has not been approved by the Food and Drug
Administration. The safety of iC9-CAR.B7-H3 T cells will be investigated using a modified
3+3 design. 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.
Subjects with TNBC who meet procurement eligibility criteria will have cells collected to
manufacture iC9-CAR.B7-H3 T cells. Eligible subjects will receive lymphodepletion with
cyclophosphamide and fludarabine.
Criteria for 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
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
University of North Carolina
Address:
City:
Chapel Hill
Zip:
27599
Country:
United States
Status:
Recruiting
Contact:
Last name:
Catherine Cheng
Phone:
919-445-4208
Email:
catherine_cheng@med.unc.edu
Investigator:
Last name:
E. Claire Dees, MD, MSc
Email:
Sub-Investigator
Start date:
June 27, 2024
Completion date:
May 2028
Lead sponsor:
Agency:
UNC Lineberger Comprehensive Cancer Center
Agency class:
Other
Collaborator:
Agency:
Bellicum Pharmaceuticals
Agency class:
Industry
Source:
UNC Lineberger Comprehensive Cancer Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06347068
http://unclineberger.org/patientcare/clinical-trials/clinical-trials
