Seven years after CAR T cell therapy first hit the market for large B-cell lymphoma in the U.S., the numbers are blunt: only two out of ten eligible patients get the treatment. The science is there. The real problem is the grind of health system logistics and manufacturing.
By June 2026, the FDA had approved seven CAR-T therapies for hematologic cancers, with expanded indications for Breyanzi in relapsed/refractory marginal zone lymphoma after at least two prior therapies.
“These therapies have mostly been built for highly specialized, top-tier centers, but most health systems aren’t set up to deliver them at scale,” said Miguel Perales, Chief of the Adult Bone Marrow Transplantation Service at Memorial Sloan Kettering Cancer Center. He says the focus now has to move from proving CAR T works to making sure people can actually get it.
Scaling up isn’t just about making more doses. Gallia Levy, Global Head of Clinical Development at Kite (a Gilead Company), described the process: collect a patient’s cells, ship them to a factory, engineer and grow the CAR T cells, then send them back for infusion—all timed to the patient’s treatment window. “The assurance that a product will be successfully manufactured and delivered when promised is equally as important as shortening cycle times,” said Laura Alquist, Kite’s Global Head of Technical Operations. For centers and patients, predictability matters as much as speed.
According to a Medicare-based review, from January 2018 to September 2023, 3,292 eligible patients over 65 years old received CAR-T therapy in the U.S., highlighting both the growth in real-world use and the persistent limitations in access for older adults.
As CAR T moves into earlier treatment and new diseases, system bottlenecks are getting worse. Perales, who co-chairs the CAR T Vision Steering Committee, is pushing for a full-on effort to break these barriers. The goal: double the share of eligible patients getting CAR T from 20% to 40% by 2030. That means bringing access beyond big academic hospitals into community clinics—a tough job, since it takes expertise, infrastructure, and money to safely give CAR T and handle its side effects.
Perales says access has to be built into therapy design from the start. Developers should work early with doctors, insurers, policymakers, and patient groups to figure out what it takes to roll out CAR T at scale. Rethinking the therapy itself—moving away from the one-patient-at-a-time model—could help ease the load on health systems.
Two new ideas could help: in vivo CAR T, which engineers T cells inside the patient, and allogeneic or iPSC-derived CAR T, which could be made ahead of time for many people. Both are still in the works, but the impact could be big. If CAR T cells could be made in batches or generated inside the body, much of today’s logistical mess could disappear.
Early clinical results show promise. Kelonia Therapeutics’ KLN-1010, an in vivo therapy for multiple myeloma, pushed all six treated patients to minimal residual disease negativity in the bone marrow after one month. MagicRNA’s HN2301 made CD19-targeting CAR T cells in five patients with tough systemic lupus erythematosus, wiping out B cells and lowering disease activity after three months. But safety is still a concern, with risks like cytokine release syndrome and other side effects.
At Boston Medical Center and Boston University, researchers are working on iPSC-derived CAR T as an off-the-shelf option. Gustavo Mostoslavsky’s team is trying to make CD4+ helper T cells, which could help control the immune response and lower the risk of cytokine storms. The goal: frozen, ready-to-use CAR T cells that can be thawed and given as needed, skipping the custom build and possibly getting therapy to more people, faster.
But off-the-shelf CAR T is still a long way off. The cells need to be tested in people, and large-scale production has to keep their therapeutic power. Making allogeneic cells less visible to the patient’s immune system is another challenge. If these hurdles fall, the economics and logistics of CAR T could change, moving from a custom job for each patient to a standard, widely available treatment.
Every new step—faster manufacturing, in vivo engineering, off-the-shelf cell banks—aims at the same question: can CAR T be made easier to make, deliver, and get, without losing safety or effectiveness? No single fix will do it. Real change has to happen across the board, from the lab to the hospital to policy.
With the CAR T Vision initiative aiming to double access by 2030, the industry has a clear job: science must be matched by real-world readiness and policy change. The future of CAR T depends not just on what’s possible in the lab, but on how well developers, providers, and policymakers break down the barriers that keep these therapies out of reach for most patients. The next chapter in cell therapy will go to those who can deliver both cures and access.
