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NCT05349890 · ClinicalTrials.gov registry record · Phase 1
Personalized TCR-T: 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
- 1
- Enrollment target
- 1
- Study location
NCT05349890: Active Phase 1 study of Malignant Epithelial Neoplasms, sponsored by Providence Health & Services.
NCT05349890 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 1 participants, below the 60-participant average among 29,502 other Phase 1 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
NCT05349890, 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
- 1 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).
Primary Outcome
Incidence of adverse events
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 | 1 participants |
| Start Date | 2023-04-03 |
| Est. Completion | 2028-04-15 |
| Phase | Phase 1 |
What the registry record for NCT05349890 still lists
NCT05349890 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 1 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (98% lower).
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.
NCT05349890 reports a single indexed study location in Oregon.
Frequently Asked Questions
What is clinical trial NCT05349890 about?
NCT05349890 is a clinical study titled "Personalized TCR-T: 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 NCT05349890?
This trial is currently active not recruiting. It is a Phase 1 study. The enrollment target is 1 participants. The study started on 2023-04-03. Estimated completion is 2028-04-15.
What conditions does trial NCT05349890 study?
This clinical trial studies the following conditions: Malignant Epithelial Neoplasms.
What interventions are being tested in trial NCT05349890?
The interventions under investigation include: Pembrolizumab (DRUG), CDX-1140 (DRUG), TCR-transduced T cells (BIOLOGICAL).
Who is sponsoring clinical trial NCT05349890?
This trial is sponsored by Providence Health & Services, which has 69 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05349890 being conducted?
This trial has 1 study location across Oregon. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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