According to the study data based on enrollment, as of December 31, 2024, a total of 109 patients received treatment with Fucaso®. The median number of prior lines of therapy was 4. Among these patients, 12.8% had EMD, and 11% had received prior BCMA CAR-T therapy. After receiving lymphodepleting preconditioning with cyclophosphamide and fludarabine for three consecutive days, patients received a single infusion of CAR-T cells (1×10⁶ cells/kg).
Among the 107 evaluable patients, the overall response (ORR) rate was 96.3%, with a complete response (CR) or stringent complete response (sCR) rate of 83.2%. In CAR-T naïve patients, the ORR and CR/sCR rates were 98.9% and 88.4%, respectively. The median progression-free survival (PFS) for the 109 patients receiving Eque-cel treatment was 30.5 months, and the median PFS extended to 35.9 months for CAR-T naïve patients. The median overall survival (OS) has not yet been reached. Minimal residual disease (MRD) negativity was achieved in 95.3% (102/107) of evaluable patients, including all patients who achieved CR or sCR, with a median duration of MRD negativity of 36.5 months. Cytokine release syndrome (CRS) occurred in 93.6% (102/109) of patients, with only 1 case being Grade ≥3. Immune effector cell-associated neurotoxicity syndrome (ICANS, Grade 1-2) was reported in 2 patients. No late-onset neurotoxicity or secondary malignancies were observed.