The rapidly evolving landscape of cancer treatment has witnessed a paradigm shift with the advent of immune effector cell therapies, notably chimeric antigen receptor T-cell (CAR-T) therapy and adoptive T-cell therapy. However, despite their unprecedented success, a significant barrier impedes the widespread application of immune effector cell therapies – the limited accessibility to these advanced treatments. This proposal outlines a comprehensive research topic aiming to define the scientific scope and vision for addressing the challenges associated with equitable access to immune effector cell therapies.

The envisioned outcome of this research topic is a comprehensive understanding of the challenges obstructing the universal availability of immune effector cell therapies. By identifying key barriers and proposing evidence-based solutions, this research aims to pave the way for policy changes, innovative business models, and collaborative efforts that enhance patient access to these transformative therapies.

Scientific Scope:

1. Economic Factors: Investigating the economic aspects surrounding immune effector cell therapies, including the cost of production, distribution, and administration. Comparative studies analyzing the cost-effectiveness of these therapies versus traditional treatments will be crucial in determining their long-term value.
2. Logistical Challenges: Analyzing the logistical hurdles in the manufacturing and delivery of immune effector cell therapies. This includes assessing the scalability of manufacturing processes, establishing efficient supply chains, and developing robust quality control measures to ensure product consistency and safety.
3. Clinical Trial Designs: Examining the clinical trial design and infrastructure required for the successful implementation of immune effector cell therapies, with focus on inclusion and decreasing disparities.
4. Patient Access and Equity: Investigating the disparities in patient access to immune effector cell therapies based on factors such as geographical location, socioeconomic status, and underrepresented demographics. Developing strategies to ensure equitable distribution and reimbursement of these therapies will be a central focus.
5. Factors affecting the choice of therapy: With advent of bispecific T cell engagers (such as mosunetuzumab, glofitamab, epcoritamab in lymphoma; teclistamab, talquetamab for myeloma) many patients who may not be able to access CAR-T in a timely manner can be offered the easily available off-the-shelf bispecific T cell engagers. Bispecific T cell engagers can also likely be used more commonly in the community given less stringent requirements for monitoring and no requirements for manufacture. Real world experience on choice of bispecific T cell antibodies vs CAR-T will be important , especially describing patterns of use in referring centers/community centers.
6. Describe the challenges globally: While CAR-T is approved in the US, there are several regulatory steps between approval and availability for patients in different countries. Awareness of the steps for approval and the state-of-affairs in different countries and continents will help the global cellular therapy community advocate for improved access.

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Frontiers in Medicine

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