AABB2026: Manufacturing Within: Are We Ready for In Vivo CAR T-cell Therapy?

Could the next generation of CAR T-cell therapies eliminate the need to manufacture cells outside the patient?

During Sunday's Biotherapies Sizzling Topics Luncheon, panelists examined the emerging field of in vivo CAR T-cell therapy, in which T cells are genetically engineered directly within the patient rather than collected, modified and expanded outside the body.

The session was moderated by Zack Thompson, MD, CABP, and featured presentations by Brenda Alder, MS, MT(ASCP)SBB, CABP(H); Vijay Bhoj, Md, PhD; and Vasiliki Kalodimou, Dr MSc, PhD, CABP(H). Presenters discussed recent scientific and clinical developments, including early clinical experience, and the potential to simplify treatment, reduce costs and expand patient access.

The presentations sparked a lively discussion, with attendees raising questions about viral-vector safety, patient management and long-term monitoring. A particularly interesting discussion centered on the differences between ex vivo and in vivo approaches, including the greater ability to characterize and control cells during traditional manufacturing compared with the more limited control possible when cells are engineered within the patient.

The panelist agreed that several questions need to be addressed. In particular, the field needs to determine that if CAR T-cell manufacturing moves from the laboratory into the patient, how will quality, control and accountability be determined and ensured? As in vivo CAR T-cell therapies advance, addressing these scientific, clinical and regulatory challenges will be essential to their safe and effective implementation.