Chimeric antigen receptor T (CAR-T) cells therapy has made remarkable progress in relapsed/refractory multiple myeloma (R/R MM) treatment. Unfortunately, patients still eventually experience disease progression or relapse even after receiving anti-BCMA CAR-T therapy. At present, there are limited data on available treatment options for patients who have progressed on anti-BCMA CAR-T therapy. In this study, we evaluated the safety and efficacy of fully human anti-BCMA CAR-T (HRC0202) in seven R/R MM patients who were previously exposed to anti-BCMA CAR-T therapy. Three patients received 6.0 × 10⁶ CAR⁺T cells/kg, one patient received 10.0 × 10⁶ CAR⁺T cells/kg and three patients received 15.0 × 10⁶ CAR⁺T cells/kg. Cytokine release syndrome (CRS) of grades 1–2 occurred in three patients (42.9%) and grade ≥3 in two patients (28.6%). Immune effector cell-associated neurotoxic syndrome (ICANS) was not observed in any of the patients. The best overall response rate (ORR) was 71.4% (5/7), with a stringent complete response/complete response (sCR/CR) achieved in three patients. The median progression-free survival (PFS) was 269 days, and median overall survival (OS) for all patients was not reached. The median peak concentration (C_max) of HRC0202 was 30117.70 (range, 6084.35–147415.10) copies/μg DNA. This study indicated that fully human anti-BCMA CAR-T (HRC0202) is a promising treatment for R/R MM patients who relapsed or refractory from prior anti-BCMA CAR-T infusion.

嵌合抗原受体T（CAR-T）细胞疗法在复发/难治性多发性骨髓瘤（R/R MM）治疗方面取得了显着进展。不幸的是，即使在接受抗 BCMA CAR-T 治疗后，患者最终仍会出现疾病进展或复发。目前，对于接受抗 BCMA CAR-T 治疗取得进展的患者，可用的治疗方案数据有限。在这项研究中，我们评估了全人源抗 BCMA CAR-T (HRC0202) 在七名先前接受过抗 BCMA CAR-T 治疗的 R/R MM 患者中的安全性和有效性。 3 名患者接受 6.0 × 10 ⁶ CAR ⁺ T 细胞/kg，1 名患者接受 10.0 × 10 ⁶ CAR ⁺ T 细胞/kg kg，三名患者接受了 15.0 × 10 ⁶ CAR ⁺ T 细胞/kg。 3 名患者 (42.9%) 发生 1-2 级细胞因子释放综合征 (CRS)，2 名患者 (28.6%) 发生≥3 级细胞因子释放综合征 (CRS)。在所有患者中均未观察到免疫效应细胞相关神经毒性综合征（ICANS）。最佳总体缓解率 (ORR) 为 71.4% (5/7)，三名患者达到严格的完全缓解/完全缓解 (sCR/CR)。中位无进展生存期 (PFS) 为 269 天，所有患者的中位总生存期 (OS) 尚未达到。 HRC0202 的中位峰浓度 (C _max ) 为 30117.70（范围，6084.35–147415.10）拷贝/μg DNA。这项研究表明，全人源抗 BCMA CAR-T (HRC0202) 是治疗因先前抗 BCMA CAR-T 输注而复发或难治的 R/R MM 患者的一种有前景的治疗方法。