CD27 装甲 BCMA CAR-T 细胞疗法（CBG-002）治疗复发/难治性多发性骨髓瘤：一项 I 期临床试验

B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy has been approved for the treatment of relapsed and refractory multiple myeloma (RRMM); however, whether patients have long-term responses has yet to be established.

We investigated the feasibility of CBG-002, a CD27-armored BCMA CAR T-cell therapy, to improve clinical efficacy in patients with RRMM.

We present preclinical data showing the activity of CBG-002 against myeloma and results from a phase I clinical trial (NCT04706936) evaluating its safety and efficacy in patients with RRMM. The primary endpoint was safety, as assessed by grade 3 or 4 adverse events (AE). Key secondary endpoints were overall response rate (ORR), duration of response (DOR), progression-free survival (PFS), and overall survival (OS). A total of 11 patients were enrolled and received CBG-002 therapy. Nine patients developed grade 1 or 2 cytokine release syndrome (CRS), whereas no patients experienced grade 3 or higher CRS or immune effector cell-associated neurotoxicity syndrome.

Other grade 3 or higher AEs included neutropenia (72. 7%), thrombocytopenia (45. 5%), and anemia (36. 4%). At a median follow-up of 16. 7 months, the ORR was 81. 8%, including a stringent complete response/complete response rate of 45. 5%, very good partial response rate of 18.

2%, and partial response rate of 18. 2%, with a median DOR of 8. 9 (range 1. 8-21. 9) months. The median OS was not reached, and the median PFS was 8. 5 (2. 7-22. 9) months. In this phase I study, CBG-002, a CD27-armored BCMA CAR T-cell therapy, demonstrated safety and clinical efficacy in patients with RRMM.