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NCT04670068 · ClinicalTrials.gov registry record · Phase 1
Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian
A Phase 1 study of Epithelial Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
- Active
- Registry status
- Phase 1
- Development phase
- 4
- Enrollment target
- 1
- Study location
NCT04670068: Active Phase 1 study of Epithelial Ovarian Cancer, sponsored by UNC Lineberger Comprehensive Cancer Center.
NCT04670068 is a Phase 1 study of Epithelial Ovarian Cancer that is active but no longer recruiting, run by UNC Lineberger Comprehensive Cancer Center. The registered enrollment target is 4 participants, below the 211-participant average among 41 other Epithelial Ovarian Cancer trials with a reported enrollment target (98% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04670068, a Phase 1 study of Epithelial Ovarian Cancer, is active but no longer recruiting, sponsored by UNC Lineberger Comprehensive Cancer Center.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 4 participants
- Enrollment target
- 1
- Study location
Study Summary
This is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.
Primary Outcome
Dose-limiting toxicity (DLT) assessments will include toxicities that are at least possibly related to the CAR.B7-H3 T cell product and that occur from the day of the initial infusion through four weeks after the final administration. DLTs are defined as toxicities of Grade ≥3. All toxicities will be classified and graded according to the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE), version 5.0, which rates severity from Grade 1 (mild) to Grade 5 (death).
Conditions Studied
Interventions
- DRUG Cyclophosphamide
- DRUG Fludarabine
- DRUG CAR.B7-H3
Study Locations (1)
North Carolina
- Lineberger Comprehensive Cancer Center - Chapel Hill
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 4 participants |
| Start Date | 2021-01-27 |
| Est. Completion | 2030-02 |
| Phase | Phase 1 |
What the registry record for NCT04670068 still lists
NCT04670068 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 4 participants, a relatively small participant target, below the 211-participant average among 41 other Epithelial Ovarian Cancer trials with a reported enrollment target (98% lower).
The record links to 1 condition, with Epithelial Ovarian Cancer appearing as the primary indexed condition, and to 3 interventions - of which Cyclophosphamide is the first listed.
NCT04670068 reports a single indexed study location in North Carolina.
Frequently Asked Questions
What is clinical trial NCT04670068 about?
NCT04670068 is a clinical study titled "Phase I Study of Autologous CAR T-Cells Targeting the B7-H3 Antigen in Recurrent Epithelial Ovarian". This is single center, open-label phase 1 dose escalation trial that uses modified 3+3 design to identify a recommended phase 2 dose (RP2D) of CAR.B7-H3 T cell product. An expansion cohort will enroll additional subjects at the RP2D for a total enrollment of up to 21 subjects on the protocol.
What is the current status of trial NCT04670068?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 4 participants. The study started on 2021-01-27. Estimated completion is 2030-02.
What conditions does trial NCT04670068 study?
This clinical trial studies the following conditions: Epithelial Ovarian Cancer.
What interventions are being tested in trial NCT04670068?
The interventions under investigation include: Cyclophosphamide (DRUG), Fludarabine (DRUG), CAR.B7-H3 (DRUG).
Who is sponsoring clinical trial NCT04670068?
This trial is sponsored by UNC Lineberger Comprehensive Cancer Center, which has 366 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04670068 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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Where NCT04670068's enrollment target sits among peer trials
4 42nd of 41 the lowest of 41 other Epithelial Ovarian Cancer trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Epithelial 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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