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采用配备HLA - A2限制性MART - 1 T细胞受体的同种异体细胞毒性T淋巴细胞进行过继性转移:转移性黑色素瘤的I期试验。

Adoptive transfer of allogeneic cytotoxic T lymphocytes equipped with a HLA-A2 restricted MART-1 T-cell receptor: a phase I trial in metastatic melanoma.

作者信息

Duval Lone, Schmidt Henrik, Kaltoft Keld, Fode Kirsten, Jensen Jens Jorgen, Sorensen Steen Mellerup, Nishimura Michael I, von der Maase Hans

机构信息

Department of Oncology , Aarhus University Hospital, Denmark.

出版信息

Clin Cancer Res. 2006 Feb 15;12(4):1229-36. doi: 10.1158/1078-0432.CCR-05-1485.

Abstract

PURPOSE

We did a phase I dose-escalation trial to evaluate the feasibility and safety of intratumoral injections of C Cure 709, an allogeneic, continuous CTL cell line that, restricted by HLA-A2, recognizes MART-1-positive tumor cells through transduction with a T-cell receptor encoding gene.

EXPERIMENTAL DESIGN

Cells were administered intratumorally in four dose levels ranging from 10(8) to 10(9) cells/d on days 1, 4, 7, 10, 14, and 28 of each treatment cycle to patients with metastatic melanoma. Main inclusion criteria were HLA-A2 tissue type, MART-1-positive tumor cells, and metastases suitable for ultrasound-guided injections. Patients were assessed for toxicity and response. Three to six patients were treated per dose level. Patients without progressive disease were offered up to three treatment cycles.

RESULTS

Fifteen patients received a total of 24 treatment cycles with a total of 266 injections of C Cure 709. Toxicity was minor to moderate and most common injection site reactions were fever, fatigue, nausea/vomiting, and arthralgia/myalgia. Side effects disappeared in general within 24 hours. Toxicity was not dose dependent. One patient obtained a partial response, encompassing both metastases used and not used for intratumoral injections. Remaining patients did not achieve an overall response. In addition, we observed local regression of metastases used for injection in two patients and of metastases not used for injection in one patient.

CONCLUSION

Intratumoral injections of C Cure 709 are feasible, safe, and capable of inducing tumor regression. Further investigation in a phase II setting is warranted.

摘要

目的

我们进行了一项I期剂量递增试验,以评估瘤内注射C Cure 709的可行性和安全性。C Cure 709是一种同种异体连续CTL细胞系,受HLA - A2限制,通过转导编码T细胞受体的基因识别MART - 1阳性肿瘤细胞。

实验设计

在每个治疗周期的第1、4、7、10、14和28天,对转移性黑色素瘤患者进行瘤内注射细胞,剂量水平分为四级,从10⁸到10⁹个细胞/天。主要纳入标准为HLA - A2组织类型、MART - 1阳性肿瘤细胞以及适合超声引导注射的转移灶。对患者进行毒性和反应评估。每个剂量水平治疗3至6名患者。无疾病进展的患者最多接受三个治疗周期。

结果

15名患者共接受24个治疗周期,总共进行266次C Cure 709注射。毒性为轻度至中度,最常见的注射部位反应为发热、疲劳、恶心/呕吐和关节痛/肌痛。副作用一般在24小时内消失。毒性与剂量无关。1例患者获得部分缓解,包括用于瘤内注射和未用于瘤内注射的转移灶。其余患者未达到总体缓解。此外,我们观察到2例患者中用于注射的转移灶以及1例患者中未用于注射的转移灶出现局部消退。

结论

瘤内注射C Cure 709是可行、安全的,并且能够诱导肿瘤消退。有必要在II期环境中进行进一步研究。

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