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The Promise of In Vivo CAR T: Expanding Access Through Off-the-Shelf Innovation

Opinion
Video

ASH 2025 data on KLN-1010 suggest that off-the-shelf, in vivo CAR T therapy could significantly expand access to cellular therapy in multiple myeloma by reducing manufacturing, treatment delays, and logistical barriers, provided toxicity remains manageable.

This interview discusses data on KLN-1010, an investigational in vivo, off-the-shelf CAR T approach presented at ASH 2025, and its potential to meaningfully expand patient access to cellular therapy in multiple myeloma. Unlike conventional autologous CAR T treatments, which require T-cell collection, complex manufacturing, lymphodepleting chemotherapy, and prolonged coordination, KLN-1010 is has potential to simplify and accelerate the treatment process.

A central theme of the discussion is access. By eliminating or substantially reducing the need for lymphodepletion, individualized manufacturing, and prolonged wait times, in vivo CAR T therapy could allow patients to receive treatment much faster. Shorter time to therapy may be particularly important in myeloma, where disease can progress rapidly while patients wait for CAR T production. Reducing these logistical barriers could also lower overall costs and decrease the physical and emotional burden on patients during treatment preparation.

Toxicity remains a critical consideration in determining how broadly this approach can be adopted. The interview emphasizes that widespread access will depend not only on feasibility but also on whether toxicities are manageable and do not routinely require hospitalization. If safety remains favorable, KLN-1010 could be delivered in a wider range of clinical settings, including community hospitals, rather than being limited to highly specialized academic centers.

The findings are also framed within the broader movement toward scalable cellular therapies. Currently, only an estimated 10% to 20% of eligible patients with multiple myeloma ultimately receive CAR T-cell therapy, due to logistical, geographic, and systemic barriers. An off-the-shelf, in vivo CAR T platform could dramatically change this landscape by enabling more centers to offer cellular therapy closer to home. Overall, the data on KLN-1010 suggest a potential paradigm shift toward simpler, more accessible CAR T strategies that could reach a much larger patient population worldwide.

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