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NCT06305299 · ClinicalTrials.gov registry record · Phase 1
Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells
A Phase 1 study of Ovarian Cancer and Epithelial Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 27
- Enrollment target
- 1
- Study location
NCT06305299: Recruiting Phase 1 study of Ovarian Cancer and Epithelial Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT06305299 is a Phase 1 study of Ovarian Cancer and Epithelial Ovarian Cancer that is actively recruiting participants, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 27 participants, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06305299, a Phase 1 study of Ovarian Cancer and Epithelial Ovarian Cancer, is actively recruiting participants, sponsored by UNC Lineberger Comprehensive Cancer Center.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 27 participants
- Enrollment target
- 1
- Study location
Study Summary
The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. The iC9.CAR.B7-H3 treatment is experimental and has not been approved by the Food and Drug Administration. The study team wants to know how much (dose) of the iC9-CAR.B7-H3 T cells are safe to use in patients without causing too many side effects and what is the maximum dose could be tolerated. There are two parts to this study. In part 1, approximately blood will be collected from subjects to prepare the iC9.CAR.B7-H3 T cells. The study team will collect disease-fighting T cells from the blood and modify them to prepare the iC9.CAR.B7-H3 T cells. In part 2, the iC9.CAR.B7-H3 T cells will be given to eligible subjects by infusion three days after completion of lymphodepletion chemotherapy.
Primary Outcome
Treatment emerged 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. Dose Limiting Toxicities (DLTs) is defined as at least possibly related to CAR.B7-H3T cell product administration.
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- BIOLOGICAL iC9-CAR.B7-H3 T cells
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 27 participants |
| Start Date | 2024-07-29 |
| Est. Completion | 2026-03 |
| Phase | Phase 1 |
What NCT06305299 shows while recruiting
NCT06305299 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 27 participants, a relatively small participant target, below the 729-participant average among 322 other Ovarian Cancer trials with a reported enrollment target (96% lower).
The record links to 4 conditions, with Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT06305299 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT06305299 about?
NCT06305299 is a clinical study titled "Autologous CAR-T Cells Targeting B7H3 in Ovarian Cancer iC9-CAR.B7-H3 T Cells". The purpose of this study is to test the safety and tolerability of using a new treatment called autologous T lymphocyte chimeric antigen receptor cells against the B7-H3 antigen (iC9-CAR.B7-H3 T cells) in patients with ovarian cancer that came back after receiving standard therapy for this cancer. ...
What is the current status of trial NCT06305299?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 27 participants. The study started on 2024-07-29. Estimated completion is 2026-03.
What conditions does trial NCT06305299 study?
This clinical trial studies the following conditions: Ovarian Cancer, Epithelial Ovarian Cancer, Recurrent, Ovary Neoplasm.
What interventions are being tested in trial NCT06305299?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), iC9-CAR.B7-H3 T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT06305299?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06305299 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
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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 NCT06305299's enrollment target sits among peer trials
27 265th of 322 higher than 56 of 322 other Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Ovarian 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.
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