Carvykti CAR-T Achieves 100% MRD Negativity in High-Risk Smoldering Multiple Myeloma (CAR-PRISM Phase 2)

Dana-Farber Cancer Institute's CAR-PRISM Phase 2 trial showed that all 20 patients with high-risk smoldering multiple myeloma treated with a single infusion of ciltacabtagene autoleucel (Carvykti, cilta-cel) achieved minimal residual disease (MRD) negativity within 2 months. All evaluable patients maintained MRD negativity at a median 15.3-month follow-up, with 100% complete or stringent complete response rates among patients with ≥6 months follow-up. No disease progression or deaths were observed, and no immune effector cell-associated neurotoxicity syndrome (ICANS) occurred. The results, presented at AACR 2026, suggest CAR-T therapy could intercept smoldering myeloma before it becomes active — a paradigm shift in treating the pre-malignant phase of the disease.