Clinical Trial

Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)

Active, Not Recruiting Phase 1
View on ClinicalTrials.gov →
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).
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2022-04-22; most recent amendment 2026-04-21.
Status change: Enrolling by Invitation → Active, Not Recruiting 2024-10-23
Status change: Not Yet Recruiting → Enrolling by Invitation 2023-06-02
Trial Details
NCT Number NCT05349890
Lead Sponsor Providence Health & Services
Collaborators: Celldex Therapeutics, Providence Cancer Center, Earle A. Chiles Research Institute
Conditions Malignant Epithelial Neoplasms
Enrollment 1 participants
Start Date 2023-04-03
Primary Completion 2027-04-15 (estimated)
Study Completion 2028-04-15 (estimated)
Updated on ClinicalTrials.gov 2026-04-24