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 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).

NCT Number	NCT04520711
Lead Sponsor	Providence Health & Services
Conditions	Malignant Epithelial Neoplasms
Enrollment	24 participants
Start Date	2022-02-08
Primary Completion	2026-12 (estimated)
Study Completion	2027-02 (estimated)
Updated on ClinicalTrials.gov	2026-04-13