The phase I study of the combined immunotherapy using alpha-galactosylceramide pulsed antigen presenting cells and tumor-specific peptide pulsed dendritic cells for patients with advanced head and neck mucosal melanoma - The phase I study with alpha-GalCer pulsed APCs and tumor peptide pulsed DCs for head and neck mucosal melanoma

开始日期2013-08-19

申办/合作机构-

JPRN-jRCTc040190130 / Completed临床2期IIT

Randomized phase II study with or without adjuvant immunotherapy of alpha-GalCer-pulsed dendritic cells in the patients with completely resected stage II-IIIA non-small cell lung cancer - Randomized phase II of adjuvant immunotherapy using alpha-GalCer-pulsed dendritic cells in completely resected stage II-IIIA non-small cell lung cancer (RADCLC)

开始日期2013-03-22

申办/合作机构-

100 项与抗原致敏的人树突状细胞(上海海欣生物) 相关的临床结果

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100 项与抗原致敏的人树突状细胞(上海海欣生物) 相关的转化医学

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100 项与抗原致敏的人树突状细胞(上海海欣生物) 相关的专利（医药）

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项与抗原致敏的人树突状细胞(上海海欣生物) 相关的文献（医药）

2016-12-01·Journal of Biomedical Science2区 · 医学

A phase I clinical study of immunotherapy for advanced colorectal cancers using carcinoembryonic antigen-pulsed dendritic cells mixed with tetanus toxoid and subsequent IL-2 treatment

2区 · 医学

ArticleOA

作者: Chung, Tsai-Rong ; Whang-Peng, Jacqueline ; Cheng, Ann-Lii ; Yu, Wei-Lan ; Liu, Ko-Jiunn ; Wu, Yu-Chen ; Chang, Jang-Yang ; Kao, Woei-Yau ; Chao, Tsu-Yi ; Ch'ang, Hui-Ju

BACKGROUNDTo better evaluate and improve the efficacy of dendritic cell (DC)-based cancer immunotherapy, we conducted a clinical study of patients with advanced colorectal cancer using carcinoembryonic antigen (CEA)-pulsed DCs mixed with tetanus toxoid and subsequent interleukin-2 treatment. The tetanus toxoid in the vaccine preparation serves as an adjuvant and provides a non-tumor specific immune response to enhance vaccine efficacy. The aims of this study were to (1) evaluate the toxicity of this treatment, (2) observe the clinical responses of vaccinated patients, and (3) investigate the immune responses of patients against CEA before and after treatment.METHODSTwelve patients were recruited and treated in this phase I clinical study. These patients all had metastatic colorectal cancer and failed standard chemotherapy. We first subcutaneously immunized patients with metastatic colorectal cancer with 1 × 10(6) CEA-pulsed DCs mixed with tetanus toxoid as an adjuvant. Patients received 3 successive injections with 1 × 10(6) CEA-pulsed DCs alone. Low-dose interleukin-2 was administered subcutaneously following the final DC vaccination to boost the growth of T cells. Patients were evaluated for adverse event and clinical status. Blood samples collected before, during, and after treatment were analyzed for T cell proliferation responses against CEA.RESULTSNo severe treatment-related side effects or toxicity was observed in patients who received the regular 4 DC vaccine injections. Two patients had stable disease and 10 patients showed disease progression. A statistically significant increase in proliferation against CEA by T cells collected after vaccination was observed in 2 of 9 patients.CONCLUSIONSThe results of this study indicate that it is feasible and safe to treat colorectal cancer patients using this protocol. An increase in the anti-CEA immune response and a clinical benefit was observed in a small fraction of patients. This treatment protocol should be further evaluated in additional colorectal cancer patients with modifications to enhance T cell responses.TRIAL REGISTRATIONClinicalTrials.gov (identifier NCT00154713 ), September 8, 2005.

2015-12-01·British Journal of Cancer1区 · 医学

A phase I/IIa study of adjuvant immunotherapy with tumour antigen-pulsed dendritic cells in patients with hepatocellular carcinoma

1区 · 医学

Article

作者: Lee, Jeong-Hoon ; Kim, Yoon Jun ; Heo, Min Kyu ; Lee, Minjong ; Kim, Ki-Hwan ; Lee, Yoon ; Song, Jae-Sung ; Lee, Hyunah ; Yi, Nam-Joon ; Bae, Yong-Soo ; Lee, Kwang-Woong ; Suh, Kyung-Suk

BACKGROUNDTo date, no adjuvant treatment has been shown to have a clear benefit in patients with hepatocellular carcinoma (HCC). In this prospective phase I/IIa study, we evaluated the safety and efficacy of adjuvant dendritic cell (DC) therapy in HCC patients who received primary treatment for HCC.METHODSTwelve HCC patients who had no viable tumour after primary treatments were included. Dendritic cell vaccines pulsed with cytoplasmic transduction peptide-attached alpha-fetoprotein, glypican-3 and melanoma-associated antigen 1 recombinant fusion proteins were injected subcutaneously near to inguinal lymph nodes. Adverse effects, time to progression (TTP), and associated immune responses were evaluated after DC vaccination.RESULTSNine of 12 patients had no tumour recurrence up to 24 weeks after DC vaccination. Among a total of 144 adverse events, 129 events (89.6%) were regarded as adverse drug reactions, all of which were grade 1 or 2. The majority of patients showed enhanced anti-tumour immune responses after DC vaccination. Recurrence-free patients exhibited relatively stronger anti-tumour immune responses than patients who developed recurrence after DC vaccination, as evidenced by lymphocyte proliferation and IFN-γ ELISPOT assays. The median time of TTP was 36.6 months in the DC-vaccination group and 11.8 months in the control group (hazard ratio, 0.41; 95% confidence interval, 0.18-0.95; P=0.0031 by log-rank test).CONCLUSIONSAdjuvant DC vaccine for HCC was safe and well tolerated in phase I/IIa study, and preliminary efficacy data are encouraging to warrant further clinical study in patients with HCC after primary treatments.

2012-12-01·Medical Oncology4区 · 医学

Adjuvant vaccination with melanoma antigen-pulsed dendritic cells in stage III melanoma patients

4区 · 医学

Article

作者: Anna Jakubowska-Mucka ; Tomasz Switaj ; Marzena Biernacka ; Hanna Polowniak-Pracka ; Henryk Skurzak ; Sergiusz Markowicz ; Aleksandra Misicka ; Andrzej W Lipkowski ; Piotr Rutkowski ; Jan Walewski ; Zbigniew I Nowecki

Dendritic cells may be successfully used to induce in vivo-specific anti-tumor responses when combined with the appropriate antigen in the appropriate context. The purpose of this study was to evaluate efficacy of peptide-loaded DC vaccine in high-risk stage III melanoma patients after lymph node dissection (LND). HLA-A2+, -A1+, or -A3+ melanoma patients (N=22), stage III, N1b-N3, received 5–16 (median: 11) DC vaccines loaded with MHC class-I-restricted melanoma peptides respective to the patient’s haplotype, and with autologous tumor lysate, if available. Vaccinated patients were matched to unvaccinated stage III controls (22 of 869) by sex, number of metastatic lymph nodes, extracapsular involvement, LND type, Breslow stage, and ulceration. Vaccination elicited cutaneous delayed-type hypersensitivity (DTH) or/and IFN-γ-producing CD8+ cell response to melanoma peptides in 15 of 22 patients. Three-year overall survival (OS) rate was 68.2% in the vaccinated group versus 25.7% in the control group, P value accounting for matching: 0.0290. In a Cox regression model, hazard ratio (HR) for death of vaccinated patients was 0.31 [95% confidence interval (CI): 0.10–0.94]. The corresponding values for 3-year disease-free survival rate were 40.9 versus 14.5%, P=0.1083; HR of recurrence for vaccinated, 0.46 (95% CI: 0.18–1.22). There was no grade>1 toxicity. The DC/peptide vaccine was well tolerated and elicited immune responses to melanoma antigens. Vaccinated patients had significantly longer OS after LND than the matched controls, but a significant improvement in the primary endpoint DFS was not achieved.

100 项与抗原致敏的人树突状细胞(上海海欣生物) 相关的药物交易

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适应症	最高研发状态	国家/地区	公司	日期
转移性结直肠癌	临床3期	中国	中国人民解放军第二军医大学	2015-12-04
转移性结直肠癌	临床3期	中国	上海海欣生物技术有限公司	2015-12-04