Recent Advances Shifting Perspectives in Cell Therapy (2025)

Engineered 'smart' immune cells now allow ultrasound control, enabling CAR T-cells to more persistently sense and kill tumor cells with less exhaustion, outperforming standard CAR T-cells in preclinical trials for solid tumors like prostate cancer and glioblastoma1.

The FDA recently updated labeling for CAR T-cell therapies, eliminating Risk Evaluation and Mitigation Strategy (REMS) requirements and cutting necessary patient monitoring to just 2 weeks post-infusion, significantly improving treatment accessibility2.

The first New Drug Application (NDA) for CAR T therapy targeting solid tumors was submitted in H1 2025, marking a major shift beyond traditional hematological indications and expanding the therapeutic reach of cell therapy5.

Globally, cell therapy innovation is accelerating:
487 new cell therapy assets and 489 new clinical trials started in H1 2025, with new approvals including China’s first mesenchymal stem cell therapy for steroid-refractory acute graft-versus-host disease3 5.

Regulatory frameworks are evolving:
The FDA is preparing a new approval pathway for highly individualized, patient-specific gene therapies, which could allow approval with very small patient cohorts for rare disorders6.

CRISPR and cell therapies continue to grow, with the FDA issuing several guidance documents for development, underscoring shifts toward more personalized and genetically modified cell therapy approaches4.