MGTA-145 or GROβT, a CXCR2 agonist, has shown promising activity for hematopoietic stem cell (HSC) mobilization with plerixafor in pre-clinical studies and healthy volunteers. Twenty-five patients with multiple myeloma enrolled in a phase 2 trial evaluating MGTA-145 and plerixafor for HSC mobilization (NCT04552743). Plerixafor was given subcutaneously followed 2 h later by MGTA-145 (0.03 mg/kg) intravenously with same day apheresis. Mobilization/apheresis could be repeated for a second day in patients who collected <6 ×106 CD34+ cells/kg. Lenalidomide and anti-CD38 antibody were part of induction therapy in 92% (n = 23) and 24% (n = 6) of patients, respectively. Median total HSC cell yield (CD34+ cells/kg × 106) was 5.0 (range: 1.1–16.2) and day 1 yield was 3.4 (range: 0.3–16.2). 88% (n = 22) of patients met the primary endpoint of collecting 2 ×106 CD34+ cells/kg in ≤ two days, 68% (n = 17) in one day. Secondary endpoints of collecting 4 and 6 × 106 CD34+ cells/kg in ≤ two days were met in 68% (n = 17) and 40% (n = 10) patients. Grade 1 or 2 adverse events (AE) were seen in 60% of patients, the most common AE being grade 1 pain, usually self-limited. All 19 patients who underwent transplant with MGTA-145 and plerixafor mobilized HSCs engrafted successfully, with durable engraftment at day 100. 74% (17 of 23) of grafts with this regimen were minimal residual disease negative by next generation flow cytometry. Graft composition for HSCs and immune cells were similar to a contemporaneous cohort mobilized with G-CSF and plerixafor.
MGTA-145（亦称GROβT）是一种CXCR2激动剂，临床前研究及健康志愿者试验显示其联合普乐沙福在造血干细胞动员方面具有良好活性。一项评估MGTA-145联合普乐沙福用于造血干细胞动员的II期试验（NCT04552743）纳入了25例多发性骨髓瘤患者。治疗方案为皮下注射普乐沙福，2小时后静脉注射MGTA-145（0.03 mg/kg），并于同日进行单采术。若采集的CD34⁺细胞量＜6×10⁶/kg，可在次日重复动员与单采流程。诱导治疗中，分别有92%（23例）和24%（6例）患者使用了来那度胺和抗CD38抗体。患者造血干细胞总采集量中位数（CD34⁺细胞×10⁶/kg）为5.0（范围：1.1-16.2），首日采集量中位数为3.4（范围：0.3-16.2）。88%（22例）患者达到主要终点（在≤2天内采集≥2×10⁶ CD34⁺细胞/kg），其中68%（17例）在一天内达成。次要终点中，68%（17例）患者在≤2天内采集到≥4×10⁶ CD34⁺细胞/kg，40%（10例）采集到≥6×10⁶ CD34⁺细胞/kg。60%患者出现1-2级不良事件，最常见的是1级疼痛（多呈自限性）。所有19例接受MGTA-145联合普乐沙福动员造血干细胞移植的患者均成功植入，且在100天时保持稳定植入。经新一代流式细胞术检测，使用该方案的移植物中74%（17/23例）达到微小残留病阴性。该方案动员获得的造血干细胞与免疫细胞移植物组成，与同期使用G-CSF联合普乐沙福动员的队列相似。
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