Cellular therapies such as chimeric antigen receptor (CAR) T-cell therapy and tumor-infiltrating lymphocyte therapy are transforming outcomes for patients with cancer, particularly in the relapsed or refractory setting. “We’re seeing outstanding response rates in patients with B-cell malignancies and multiple myeloma—even in those who are heavily pretreated,” said Folashade Otegbeye, MBChB, MPH, Associate Professor at Fred Hutchinson Cancer Center and the University of Washington, and Facility Director of the Therapeutic Products Program at Fred Hutch. “And, some of these responses are durable for years.”
However, as Dr. Otegbeye emphasized at the 2025 Summit on Cancer Health Disparities in Seattle, the success of these therapies has not been equitably distributed. “We have these life-saving products,” she said, “but the barriers to access are real and layered.”
The Multistep Burden of Access
CAR T-cell therapies involve genetically modifying a patient’s T cells to target tumor antigens, whereas tumor-infiltrating lymphocyte therapy harnesses and expands the patient’s own tumor-infiltrating immune cells without genetic manipulation. Both approaches have demonstrated survival benefits in select populations and are now approved for multiple hematologic malignancies, melanoma, and synovial sarcoma, with ongoing clinical trials in solid tumors and other hematologic malignancies.1-3
However, the journey to receiving CAR T-cell or tumor-infiltrating lymphocyte therapy is long and complex. It begins with referral and evaluation, followed by leukapheresis or tumor tissue harvesting. The collected cells are then sent for manufacturing—a process that can take several weeks—after which patients undergo lymphodepleting chemotherapy and infusion.
Each step carries logistical and financial burdens. “There’s the cost of manufacturing, yes,” said Dr. Otegbeye, “but also the unspoken cost of bridging therapy (and complications), hospitalizations, transportation, monitoring after infusion, and local lodging.”
In some cases, patients may receive additional chemotherapy during the manufacturing window to keep their disease under control. But complications from bridging therapy can disqualify patients from ultimately receiving their personalized product. Even after infusion, patients face risks such as cytokine-release syndrome, immune effector cell–associated neurotoxicity syndrome, pancytopenia, and other neurotoxicities and infections—requiring close monitoring and support systems that many cannot afford.
Infrastructure and Policy Constraints
Institutional and regulatory protocols meant to ensure safety can inadvertently reduce access. “For FDA-approved CAR T-cell therapies, patients must reside within 2 hours of the treatment center and have a full-time caregiver available for 30 days,” Dr. Otegbeye explained. Many centers, including Fred Hutch, enforce strict care and local lodging policies during the high-risk period after infusion.
These requirements pose steep challenges for patients who live in rural areas, lack housing options near the treatment center, or cannot afford for themselves and their caregivers to take extended leave from work. “We know these policies are intended to protect patients,” she said, “but we also have to ask who are we excluding as a result of the policies?”
Medicaid, for instance, reimburses housing up to $90 per night in Washington State, whereas short-term housing near Fred Hutch can cost well over $100 per night.4 Caregiver availability is another frequent barrier, particularly for patients with children, dependents, or limited support networks. “It becomes what we call a ‘caregiver conundrum,’” she added.
Disparities in Referral and Awareness
According to Dr. Otegbeye, access issues often begin at the referral stage, well before treatment. “Less than 4% of health centers in the United States can provide CAR T-cell therapies,” she noted. “That means most oncologists, particularly in rural settings, have to refer their patients for these treatments.”
Fred Hutch is now conducting a retrospective review of its referral pipeline from 2016 to 2024—the Fred Hutch Immunotherapy (IMTX) Access Initiative—to identify geographic referral gaps and drop-off points. “We’re seeing patients come from far away, from places like San Juan County [Washington], but not necessarily at similar rates, in proportion, from the counties closer to King County [where Fred Hutch is located],” she said.
The team is analyzing attrition rates and reasons between referral, arrival to the IMTX service, and treatment and working to develop interventions and metrics to track progress. “We’re trying to figure out who we’re missing and how to do better,” she said.
Awareness among patients is also a barrier. “We’re introducing genetically modified cells, and some patients, their families, and communities have concerns about DNA, mRNA—so education matters,” she said, noting a comparison to what was seen during the COVID vaccine era.
Racial and Socioeconomic Inequities
Multiple studies have documented racial and ethnic disparities in access to cellular therapies. “But these disparities are not driven by disease biology,” she said. “They’re access-related.”
Social determinants such as income, housing, and transportation continue to shape who gets referred, who makes it to the clinic, and who ultimately receives treatment. According to Dr. Otegbeye, an inverse relationship exists between distance from a treatment center and probability of access to CAR T-cell therapy, highlighting the impact of geography on eligibility and uptake.
National and International Efforts to Improve Access
Although Fred Hutch has launched the IMTX Access Initiative to identify and address barriers within its own system, on the national level, the American Society for Transplantation and Cellular Therapy and the National Marrow Donor Program have established their own ACCESS Initiative to promote equity in hematopoietic cell transplantation and cellular therapy.5 “These efforts are important,” said Dr. Otegbeye, “but they must be sustained and intentional.”
As CAR T and other cellular therapies continue to expand, she emphasized the need to redesign policies and pathways with equity in mind. Dr. Otegbeye concluded: “If we don’t address access, we’ll continue to leave behind the very patients these therapies were designed to help.”
DISCLOSURE: Dr. Otegbeye reported no conflicts of interest.
REFERENCES
1. Cappell KM, Kochenderfer JN: Nat Rev Clin Oncol 20:359-371, 2023.
2. Chesney J, et al: J Immunother Cancer 10:e005755, 2022.
3. D’Angelo SP, et al: Lancet 403:1460-1471, 2024.
4. Auletta JJ, et al: Transplant Cell Ther 29:713-720, 2023.
5. Auletta JJ, et al: Transplant Cell Ther 28:802-809, 2022.
