Trials / Recruiting
RecruitingNCT06347068
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
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 42 (estimated)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | iC9-CAR.B7-H3 T Cell Therapy | iC9-CAR.B7-H3 T cells will then be administered intravenously |
| DRUG | cyclophosphamide | cyclophosphamide 300 mg/m2 IV will be given. |
| DRUG | fludarabine | fludarabine 30 mg/m2 IV will be given. |
Timeline
- Start date
- 2024-06-27
- Primary completion
- 2026-05-01
- Completion
- 2028-05-01
- First posted
- 2024-04-04
- Last updated
- 2025-09-16
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT06347068. Inclusion in this directory is not an endorsement.