Personalized TCR-T: Study of Adoptively Transferred T-cell Receptor Gene-engineered T Cells (TCR-T)
Status:
Not yet recruiting
Trial end date:
2027-06-15
Target enrollment:
Participant gender:
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).