- The shift from ex vivo to in vivo CAR-Therapies
Perhaps the most significant scientific shift visible at ISCT this year was the momentum building behind in vivo approaches to CAR-T-cell therapy. Traditionally, CAR-T manufacturing has relied on an ex vivo process. This approach works, but it is logistically intensive, expensive, and difficult to scale.
In vivo CAR-Therapy aims to bypass this by delivering the engineering machinery, often via viral vectors or lipid nanoparticles, directly into the patient’s body, where it targets and reprograms the appropriate cells in situ. Early phase clinical data presented at ISCT suggest this approach is progressing beyond concept, with several trials already underway and more in planning across major pharmaceutical companies.
From a laboratory services perspective, this shift has important implications. As in vivo approaches progress through clinical development, the assays required to support these trials will need to evolve accordingly.
- Expanding beyond oncology: autoimmune disease and beyond
For much of its history, cell and gene therapy has been associated primarily with oncology. ISCT 2026 signaled that this is changing. A dedicated full-day session on non-oncology indications, something uncommon in the context of CAR-T therapy, reflected just how far the field has broadened.
Autoimmune diseases have emerged as a particularly compelling area, with early clinical data showing encouraging results and a rapidly expanding body of research. But the expansion does not stop there. Researchers are exploring CAR-based approaches in neurodegenerative disease, metabolic conditions, and other indications that would have seemed far-fetched even a few years ago.
Running alongside this scientific ambition is an urgent practical question: current therapies reach only a small fraction of those who could benefit. Expanding access through simpler manufacturing, lower cost, and improved logistics is becoming as important a priority as developing the therapies themselves.
- Regulation is keeping pace, including new rigor around clinical trial standards
A recurring theme across sessions was the evolving regulatory environment. Far from being a brake on progress, regulators are increasingly active partners in shaping the field’s development. The FDA’s recent move to request randomized controlled clinical trial data for CAR-T therapies, which was previously a rare expectation in this space, reflects a maturing relationship between innovators and oversight bodies.
For laboratory partners, this trajectory matters. As trial standards become more rigorous and more standardized, the quality, reproducibility, and documentation of analytical data become even more important.