Immuno-oncology technology最新文献

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Safety and feasibility of blood-derived multiple antigen-specific endogenously derived T cells (MASE-T) for metastatic melanoma 血液来源的多种抗原特异性内源性T细胞（MASE-T）治疗转移性黑色素瘤的安全性和可行性

Immuno-oncology technology

Pub Date : 2025-12-19 DOI: 10.1016/j.iotech.2025.101581

T.J. Monberg , S.A. Tvingsholm , M. Svensson-Frej , C. Vestergaard , M. Ormhøj , J.W. Kjeldsen , T.H. Borch , R.B. Holmstroem , N. Jayashankar , J.S. Granhøj , A.R. Cordt , S.K. Larsen , Ö. Met , S.R. Hadrup , I.M. Svane

Background

Tumor-infiltrating lymphocyte (TIL) therapy is effective in metastatic melanoma (MM), but the need for resectable tumor tissue limits its accessibility. Antigen-presenting scaffolds (Ag-scaffolds) constitute a technology developed for the specific expansion of tumor-associated antigen (TAA)-specific T cells directly from peripheral blood. Ag-scaffolds are built on a dextran backbone with coattached interleukin 2 (IL-2), interleukin 21 (IL-21), and major histocompatibility complex class I molecules loaded with the top 30 most frequently expressed TAAs in MM patients. The resulting multiple antigen-specific endogenously derived T-cell (MASE-T) infusion product is enriched for CD8+ TAA-specific T cells. We hypothesize that treatment with MASE-T therapy is safe and feasible in patients with immune checkpoint inhibitor (ICI)-resistant MM.

Patients and methods

In this phase I, first-in-human, clinical trial (NCT04904185), six patients with ICI-resistant MM received MASE-T therapy preceded by 3 days of lymphodepleting chemotherapy with cyclophosphamide and fludarabine phosphate. The primary endpoint was the safety and feasibility of the treatment.

Results

MASE-T cells were successfully expanded in 88% (7/8) of the included patients, and most MASE-T products were enriched for T-cell populations targeting multiple TAAs. Administration of MASE-T therapy was safe with no MASE-T-related toxicities. Clinical efficacy was limited, with 3 out of 6 (50%) patients having stable disease 6 weeks after treatment.

Conclusions

This trial demonstrates that Ag-scaffold-driven expansion of TAA-specific T cells from the peripheral blood of patients with MM is feasible, and the resulting MASE-T infusion product can be safely administered. However, further development is required to unleash the full potential of this technology.

肿瘤浸润淋巴细胞（TIL）治疗转移性黑色素瘤（MM）是有效的，但需要切除肿瘤组织限制了其可及性。抗原呈递支架（Ag-scaffolds）是一种用于直接从外周血中特异性扩增肿瘤相关抗原（TAA）特异性T细胞的技术。ag -支架构建在葡聚糖骨架上，并结合白介素2 （IL-2）、白介素21 （IL-21）和主要组织相容性复合体I类分子，这些分子装载MM患者中最常表达的前30种TAAs。由此产生的多种抗原特异性内源性T细胞（MASE-T）输注产物富含CD8+ taa特异性T细胞。患者和方法在这项I期首次人体临床试验（NCT04904185）中，6例ci耐药MM患者接受了MASE-T治疗，然后用环磷酰胺和磷酸氟达拉滨进行了3天的淋巴细胞消耗化疗。主要终点是治疗的安全性和可行性。结果88%（7/8）的患者成功扩增smase - t细胞，大多数MASE-T产物富集于靶向多个TAAs的t细胞群。给予MASE-T治疗是安全的，没有MASE-T相关的毒性。临床疗效有限，6例患者中有3例（50%）在治疗后6周病情稳定。结论该试验表明，ag支架驱动的从MM患者外周血中扩增taa特异性T细胞是可行的，并且由此产生的MASE-T输注产品可以安全使用。然而，要充分发挥这项技术的潜力，还需要进一步发展。

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引用次数: 0

Safety and efficacy of immune checkpoint inhibitors in patients with melanoma and pre-existing autoimmune conditions: a systematic review and meta-analysis 免疫检查点抑制剂在黑色素瘤和自身免疫性疾病患者中的安全性和有效性：一项系统综述和荟萃分析

Immuno-oncology technology

Pub Date : 2025-12-02 DOI: 10.1016/j.iotech.2025.101559

S. Haider , M. Hong , J. Descallar , B. Balakrishnar , T.L. Roberts , K. Keat , W. Chua

Background

Melanoma patients with pre-existing autoimmune diseases (AIDs) have been excluded from clinical trials of immune checkpoint inhibitors (ICIs), due to a risk of flare and immune-related adverse effects (irAEs).

Materials and methods

A comprehensive literature search of Medline, Embase, CINAHL and Scopus was carried out. Studies of melanoma patients with pre-existing AIDs were included. Two reviewers used the Preferred Reporting Items for Systematic Reviews and Meta-Analysis (PRISMA) guidelines. Outcomes assessed included all-grade and grade 3 or 4 de novo irAEs, AID flare, treatment discontinuation owing to adverse effect(s), treatment-related mortality and objective response rate (ORR).

Results

Thirty-two percent of patients with AIDs developed a flare, with 80% requiring immunosuppression. In patients with AIDs, meta-analysis revealed a higher risk of all-grade irAEs [risk ratio (RR) 1.16, 95% confidence interval (CI) 1.01-1.33, P = 0.0106] but not grade 3 or 4 (RR 1.21, 95% CI 0.99-1.47, P = 0.0663). Treatment discontinuation, treatment-related mortality and ORR were not different among patients with AIDs.

Conclusions

Melanoma patients with pre-existing AIDs are at significant risk of flare with ICI use. These patients had an increased risk of irAEs of any grade. Although there was a trend towards increased risk of severe irAEs, this was not statistically significant. irAEs did not result in treatment-related deaths, and there were no differences in treatment response. Risks should be discussed, coupled with close monitoring.

已有自身免疫性疾病（AIDs）的黑色素瘤患者被排除在免疫检查点抑制剂（ICIs）的临床试验之外，因为有爆发和免疫相关不良反应（irAEs）的风险。材料与方法对Medline、Embase、CINAHL、Scopus进行综合文献检索。研究对象包括已有艾滋病的黑色素瘤患者。两位审稿人使用了系统评价和荟萃分析（PRISMA）指南的首选报告项目。评估的结局包括所有级别和3级或4级的新发irae、AID耀斑、因不良反应而停止治疗、治疗相关死亡率和客观缓解率（ORR）。结果32%的艾滋病患者出现急性发作，其中80%需要免疫抑制。在艾滋病患者中，荟萃分析显示所有级别irae的风险较高[风险比（RR） 1.16, 95%可信区间（CI） 1.01-1.33, P = 0.0106]，但3级或4级的风险较高（RR 1.21, 95% CI 0.99-1.47, P = 0.0663）。治疗中止、治疗相关死亡率和ORR在艾滋病患者之间没有差异。结论已存在艾滋病的恶性肿瘤患者使用ICI后有明显的复发风险。这些患者发生任何级别irae的风险都有所增加。尽管有严重的irae风险增加的趋势，但这在统计学上并不显著。irae没有导致治疗相关的死亡，治疗反应也没有差异。应该讨论风险，同时密切监测。

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