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NCT04520711 · ClinicalTrials.gov registry record · Phase 1
Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)
A Phase 1 study of Malignant Epithelial Neoplasms, sponsored by Providence Health & Services.
- Active
- Registry status
- Phase 1
- Development phase
- 24
- Enrollment target
- 1
- Study location
NCT04520711 is a Phase 1 study of Malignant Epithelial Neoplasms that is active but no longer recruiting, run by Providence Health & Services. The registered enrollment target is 24 participants. The trial reports 1 study location across 1 state.
The verdict
NCT04520711, a Phase 1 study of Malignant Epithelial Neoplasms, is active but no longer recruiting, sponsored by Providence Health & Services.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 1
- Development phase
- 24 participants
- Enrollment target
- 1
- Study location
Study Summary
This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Simon's Two-Stage expansion design, 80% power and 5% one-sided alpha: stage-one futility assessment at n = 10; stage-two assessment at n = 22, (accrual up to 24 to allow for potential study drop-out).
Conditions Studied
Interventions
- DRUG Pembrolizumab
- DRUG CDX-1140
- BIOLOGICAL TCR-transduced T cells
Study Locations (1)
Oregon
- Providence Portland Medical Center - Portland
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 24 participants |
| Start Date | 2022-02-08 |
| Est. Completion | 2027-02 |
| Phase | Phase 1 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04520711
The ClinicalTrials.gov registry entry for NCT04520711 describes a study currently listed as active not recruiting, categorized as Phase 1. The registered enrollment target is 24 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Providence Health & Services, which has 69 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Malignant Epithelial Neoplasms appearing as the primary indexed condition, and to 3 interventions - of which Pembrolizumab is the first listed.
NCT04520711 reports 1 study location spanning 1 distinct geographic area - top geographies include Oregon.
Frequently Asked Questions
What is clinical trial NCT04520711 about?
NCT04520711 is a clinical study titled "Hotspot TCR-T: A Phase I/Ib Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)". This is a phase I/Ib study of adoptively transferred T-cell receptor gene-engineered T cells (TCR-T) targeting tumor-specific antigens, with in vivo CD40 activation and PD-1 blockade, for patients with incurable cancers. The study design is a safety lead-in TCR-T with CD40/PD-1 (3+3), followed by Si...
What is the current status of trial NCT04520711?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 24 participants. The study started on 2022-02-08. Estimated completion is 2027-02.
What conditions does trial NCT04520711 study?
This clinical trial studies the following conditions: Malignant Epithelial Neoplasms.
What interventions are being tested in trial NCT04520711?
The interventions under investigation include: Pembrolizumab (DRUG), CDX-1140 (DRUG), TCR-transduced T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT04520711?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04520711 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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