肿瘤细胞治疗研究
英文原题：CD7 targeted "off-the-shelf" CAR-T demonstrates robust in vivo expansion and high efficacy in the treatment of patients with relapsed and refractory T cell malignancies.
在扩展研究中，12 例患者中有 11 例在 GC027 输注后 1 个月内快速清除 T 淋巴母细胞并达到完全缓解。
T细胞急性淋巴细胞白血病（T-ALL）仍有极大的未满足医疗需求。疾病复发后，患者治疗选择有限且预后较差。CD7等T-ALL抗原也广泛表达于正常T细胞和自然杀伤（NK）细胞，因此将CAR-T疗法拓展至T细胞恶性肿瘤面临CAR-T细胞相互杀伤、生产成本高及产品潜在污染等挑战。GC027是一种用于T细胞恶性肿瘤的现货型异基因CD7靶向CAR-T产品，在小鼠异种移植模型中显示出较强的细胞扩增和抗白血病活性。此前研究中，前两例接受GC027治疗的复发或难治性（R/R）T-ALL患者取得了令人鼓舞的疗效。在扩展研究中，12例患者中的11例在GC027输注后迅速清除T淋巴母细胞，并在1个月内达到完全缓解。输注后GC027细胞迅速扩增，约在第5至10天达到峰值。对多数有应答患者（9/11），输注4周后流式细胞术或qPCR已无法检出GC027。一名患者无进展生存期超过3年。在毒性可控的情况下，GC027在R/R T细胞恶性肿瘤中显示出优于标准化疗方案的临床疗效。
T-cell acute lymphoblastic leukemia (T-ALL) represents an area of highly unmet medical needs. Once relapsed, patients have limited treatment options and poor prognosis. T-ALL antigens such as CD7 is extensively expressed in normal T cells and natural killer (NK) cells, and extending the success of CAR-T therapy to T cell malignancies was challenged by CAR-T cell fratricide, high production cost, and potential product contaminations. GC027 is an "off-the-shelf" allogeneic CD7 targeted CAR-T therapeutic product for T cell malignancies. It demonstrated superior cell expansion and antileukemia efficacy in mouse xenograft model. In our previous study, we observed promising efficacy results in the first two relapsed and refractory(R/R) T-ALL patients treated with GC027. In the expanded study, 11 out of 12 patients had rapid eradication of T-lymphoblasts and reached complete response within 1-month after GC027 infusion. GC027 cells expanded quickly beginning at infusion and reached to peak around 5-10 days after infusion. For most patients with a response(9/11), GC027 could not be detected via flow cytometry or qPCR 4 weeks after infusion. One patient had progression free survival of >3 years. With manageable toxicity profile, GC027 demonstrated superior clinical efficacy to standard chemotherapy regimens in (R/R) T cell malignancies.
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