CYT107

A Phase 0 immune-readiness step, potentially using IL-7 (e.g., CYT107), is intended to improve the baseline substrate before antigen exposure. Phase 1 priming uses peptide vaccination on a commonly used adjuvant backbone such as Montanide ISA-51 or poly-ICLC (Hiltonol), while radiation and/or STING-based strategies are treated as context-dependent enhancers rather than replacements for priming...Although organized as sequential phases, the framework is intended as a bottleneck-guided and iterative design logic in which phases may overlap, repeat, or be entered in partial parallel depending on the dominant biologic constraint. The central hypothesis is that vaccine programs that progress beyond priming into trafficking-competent and functionally sustained states are predicted to correlate more closely with disease control than programs judged mainly by early blood immunogenicity.

P2, N=55, Recruiting, National Cancer Institute (NCI) | Not yet recruiting --> Recruiting

P2, N=55, Not yet recruiting, National Cancer Institute (NCI)

P1, N=30, Recruiting, Washington University School of Medicine | Not yet recruiting --> Recruiting

Combining CYT107 with atezolizumab was safe and resulted in lymphocyte expansion, a doubling of the CR rate, and durable responses exceeding 2 years, however, the ORR was similar to atezolizumab alone. Increased and sustained doses of CYT107 coupled with patient selection strategies should be further investigated.

P1, N=30, Not yet recruiting, Washington University School of Medicine | Trial completion date: Oct 2028 --> Jan 2029 | Initiation date: Oct 2024 --> Jan 2025 | Trial primary completion date: Oct 2028 --> Jan 2029

P1, N=30, Not yet recruiting, Washington University School of Medicine

P2, N=47, Completed, National Cancer Institute (NCI) | Active, not recruiting --> Completed | Trial completion date: Oct 2024 --> Apr 2024

P2, N=8, Terminated, Revimmune | N=12 --> 8 | Trial completion date: Dec 2022 --> Mar 2024 | Recruiting --> Terminated | Trial primary completion date: Dec 2022 --> Dec 2023; non convincing results

P2, N=10, Terminated, Revimmune | Active, not recruiting --> Terminated; POOR ACCRUAL

This is the first randomized trial of atezo +/- IL-7 (CYT107) in mUC. During the trial, the FDA approval for atezo in mUC was withdrawn, which limited enrollment. However, our results show that the addition of CYT107 to atezo is safe/tolerable, with comparable toxicity profile and efficacy to monotherapy.

P2, N=47, Active, not recruiting, National Cancer Institute (NCI) | Trial completion date: Dec 2023 --> Oct 2024 | Trial primary completion date: Dec 2023 --> Sep 2023