肿瘤细胞治疗研究
英文原题：Lisocabtagene maraleucel combined with ibrutinib in R/R CLL or SLL: primary results from TRANSCEND CLL 004.
TRANSCEND CLL 004 研究是一项 1/2 期、开放标签研究，其 liso-cel 联合 ibrutinib 队列中的患者患有复发/难治性慢性淋巴细胞白血病 (CLL)/小淋巴细胞淋巴瘤 (SLL)，患者接受 liso-cel（50×106 [剂量水平 (DL)1] 或 100×106 [DL2] 嵌合抗原受体阳性 T 细胞）治疗，并从入组起至 liso-cel 输注后 90 天或根据研究者判断更长时间内同时接受 ibrutinib 治疗。
liso-cel联合ibrutinib队列来自1/2期开放标签TRANSCEND CLL 004研究，患者为复发/难治性慢性淋巴细胞白血病(CLL)/小淋巴细胞淋巴瘤(SLL)，接受liso-cel(50×106[剂量水平(DL)1]或100×106[DL2]嵌合抗原受体阳性T细胞)治疗，并从入组至liso-cel输注后90天或根据研究者判断更长时间内同时接受ibrutinib治疗。主要终点为研究者评估的完全缓解/完全缓解(CR)/伴骨髓恢复不完全的CR(CRi)。在56例接受ibrutinib联合liso-cel治疗的患者中(DL1，n=5；DL2，n=51)，中位(范围)年龄为64.5岁(44‒77)，98%具有高危细胞遗传学，55%在Bruton酪氨酸激酶抑制剂治疗期间进展且venetoclax治疗失败，中位(范围)既往治疗线数为5(1‒13)。中位(范围)随访时间为24.8个月(3.1‒51.8)。在DL2，CR/CRi率为45%(95%置信区间[CI]，31‒60)，总缓解率为86%(95% CI，74‒94)。CR/CRi患者的中位(95% CI)缓解持续时间未达到(NR；28.7‒NR)，所有缓解者的中位(95% CI)缓解持续时间为41.4个月(23.3‒NR)。中位(95% CI)无进展生存期为31.4个月(20.1‒NR)。在DL1+DL2中，最常见的≥3级治疗中出现的不良事件(TEAE)为中性粒细胞减少(52%)和贫血(41%)。细胞因子释放综合征报告于80%的患者(3级，4%；无4/5级)，神经系统事件报告于41%(3/4级，11%；无5级)。ibrutinib相关TEAE报告于68%的患者(3/4级，43%；无5级)。liso-cel联合ibrutinib在复发/难治性CLL/SLL患者中显示出显著疗效，且安全性可预测且可管理。Clinicaltrials.gov：NCT03331198；NCT03435796。
Patients in the liso-cel plus ibrutinib cohort of the phase 1/2, open-label TRANSCEND CLL 004 study had relapsed/refractory chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL) and received liso-cel (50×106 [dose level (DL)1] or 100×106 [DL2] chimeric antigen receptor-positive T cells) with concurrent ibrutinib from enrollment through 90 days after liso-cel infusion or longer per investigator discretion. Primary end point was complete response/remission (CR)/CR with incomplete marrow recovery (CRi) by investigator assessment. Among 56 patients who received ibrutinib plus liso-cel (DL1, n=5; DL2, n=51), median (range) age was 64.5 years (44‒77), 98% had high-risk cytogenetics, 55% had progression on Bruton tyrosine kinase inhibitor and venetoclax failure, and median (range) number of prior therapies was 5 (1‒13). Median (range) follow-up was 24.8 months (3.1‒51.8). At DL2, CR/CRi rate was 45% (95% confidence interval [CI], 31‒60) and overall response rate was 86% (95% CI, 74‒94). Median (95% CI) duration of response was not reached (NR; 28.7‒NR) for patients with CR/CRi and 41.4 months (23.3‒NR) for all responders. Median (95% CI) progression-free survival was 31.4 months (20.1‒NR). In DL1+DL2, most common grade ≥3 treatment-emergent adverse events (TEAE) were neutropenia (52%) and anemia (41%). Cytokine release syndrome was reported in 80% of patients (grade 3, 4%; no grade 4/5), and neurological events in 41% (grade 3/4, 11%; no grade 5). Ibrutinib-related TEAEs were reported in 68% of patients (grade 3/4, 43%; no grade 5). Liso-cel plus ibrutinib demonstrated notable efficacy in patients with relapsed/refractory CLL/SLL with predictable and manageable safety. Clinicaltrials.gov: NCT03331198; NCT03435796.
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