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NCT06347068 · ClinicalTrials.gov registry record · Phase 1
Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells
A Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 42
- Enrollment target
- 1
- Study location
NCT06347068: Recruiting Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06347068 is a Phase 1 study of Breast Cancer and Triple Negative Breast Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 42 participants, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06347068, a Phase 1 study of Breast Cancer and Triple Negative Breast Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 42 participants
- Enrollment target
- 1
- Study location
Study 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).
Primary Outcome
Toxicity will be graded as the Number of participants with adverse events (AE)s AEs will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI-CTCAE) version 5.0.
Conditions Studied
Interventions
- DRUG fludarabine
- DRUG cyclophosphamide
- BIOLOGICAL iC9-CAR.B7-H3 T Cell Therapy
Study Locations (1)
North Carolina
- University of North Carolina - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 42 participants |
| Start Date | 2024-06-27 |
| Est. Completion | 2028-05 |
| Phase | Phase 1 |
What NCT06347068 shows while recruiting
NCT06347068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 42 participants, a relatively small participant target, below the 2,803-participant average among 1,224 other Breast Cancer trials with a reported enrollment target (99% lower).
The record links to 4 conditions, with Breast Cancer appearing as the primary indexed condition, and to 3 interventions - of which fludarabine is the first listed.
NCT06347068 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06347068 about?
NCT06347068 is a clinical study titled "Study of Autologous CAR-T Cells Targeting B7-H3 in TNBC iC9-CAR.B7-H3 T Cells". 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).
What is the current status of trial NCT06347068?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 42 participants. The study started on 2024-06-27. Estimated completion is 2028-05.
What conditions does trial NCT06347068 study?
This clinical trial studies the following conditions: Breast Cancer, Triple Negative Breast Cancer, Relapse, Resistant Cancer.
What interventions are being tested in trial NCT06347068?
The interventions under investigation include: fludarabine (DRUG), cyclophosphamide (DRUG), iC9-CAR.B7-H3 T Cell Therapy (BIOLOGICAL).
Who is sponsoring clinical trial NCT06347068?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06347068 being conducted?
This trial has 1 study location across North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Breast Cancer
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT06347068's enrollment target sits among peer trials
42 864th of 1224 higher than 356 of 1,224 other Breast Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Breast Cancer trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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