The CITN is an offspring of the NCI Immunotherapy Agent Workshop, held in July 2007, where participants ranked a list of agents with high potential to serve as immunotherapeutic drugs for cancer. All of the prioritized agents had proven immunologic or physiologic function. Yet, even today, none are broadly available for testing in patients with cancer.
Building on the decisions made at the initial and two subsequent NCI prioritization workshops detailed below, the CITN will focus on conducting early phase clinical trials that use agents and novel regimens with consensus prioritization that are most likely to prove effective and lead to regulatory approval in the foreseeable future.
The CITN has limited funding. Thus, the CITN must select and prioritize its projects judiciously and strategically by:
Focusing on agents with known and proven biologic function that have received consensus prioritization in previous NCI workshops
Focusing on regimens with clear immunologic endpoints likely to inform the next phases of drug development — specifically, those that prospectively and predictably increase the number of T cells specific for known and defined antigens
Developing regimens that can be applied in multiple circumstances by multiple investigators
Providing high-quality immunogenicity and biomarker data that elucidate mechanisms of response or failure and thereby facilitate the design of subsequent trials
Using only GMP agents with validated reproducible and reliable manufacturing at scale by a company, the NExT (NCI Experimental Therapeutics) program, the former RAID (Rapid Access to Interventional Development) program, or an equivalent experienced organization
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