Phase I/II Trial of Pembrolizumab and Androgen-receptor Pathway Inhibitor With or Without 225Ac-J591 for Progressive Metastatic Castration Resistant Prostate Cancer

This is a phase I/II study investigating the combination of 225Ac-J591 (a drug that can deliver radiation to prostate cancer cells) with pembrolizumab (immunotherapy, a drug that increases the immune system's ability to destroy cancer cells). This study will assess whether 225Ac-J591 + pembrolizumab + androgen receptor pathway inhibitor (ARPI) is more effective against prostate cancer than pembrolizumab + ARPI alone.

开始日期2021-08-12

申办/合作机构

Weill Medical College of Cornell University

[+2]

NCT04886986

/ Suspended临床1/2期IIT

Phase I/II Study of 225Ac-J591 Plus 177Lu-PSMA-I&T for Progressive Metastatic Castration Resistant Prostate Cancer

This is a phase I/II dose-escalation study of 225Ac-J591 administered together with 177Lu-PSMA-I&T (also known as PNT2002). The two study drugs are 225Ac-J591 and 177Lu-PSMA-I&T. Both drugs are designed to deliver radiation to prostate cancer cells; they are known as radionuclide conjugates (radiation linked to antibodies/molecules that recognize prostate cancer cells). The first phase of the study (phase I) will determine the highest dose of the study drug that can be safely given. The second phase of the study (phase II) will determine the effectiveness of the drug combination in patients with prostate cancer.

开始日期2021-06-30

申办/合作机构

Weill Medical College of Cornell University

NCT04576871

/ Active, not recruiting早期临床1期IIT

Pilot Study of PSMA-TRT Re-treatment Utilizing 225Ac-J591

The purpose of this study is to find out if re-treatment with 225Ac-J591 can be given without severe side effects.

开始日期2020-10-29

申办/合作机构

Weill Medical College of Cornell University

100 项与 225Ac-J591 相关的临床结果

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100 项与 225Ac-J591 相关的转化医学

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100 项与 225Ac-J591 相关的专利（医药）

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项与 225Ac-J591 相关的文献（医药）

2024-06-03·Clinical cancer research : an official journal of the American Association for Cancer Research

Preclinical Efficacy of a PSMA-Targeted Actinium-225 Conjugate (225Ac-Macropa-Pelgifatamab): A Targeted Alpha Therapy for Prostate Cancer

Article

作者: Klotz, Monika ; Hammer, Stefanie ; Nielsen, Carsten H. ; Indrevoll, Bård ; Larsen, Åsmund ; Alfsen, Maria Z. ; Schatz, Christoph A. ; Cuthbertson, Alan ; Feng, Yuan Zeng ; Nair, Shankari ; Stargard, Stefan ; Bjerke, Roger M. ; Cruciani, Veronique ; Hagemann, Urs B. ; Hennekes, Hartwig ; Moen, Ingrid ; Zitzmann-Kolbe, Sabine ; Wickstrøm Biseth, Katrine ; Haendler, Bernard ; Karlsson, Jenny

Abstract:

Purpose::

Initially, prostate cancer responds to hormone therapy, but eventually resistance develops. Beta emitter-based prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy is approved for the treatment of metastatic castration-resistant prostate cancer. Here we introduce a targeted alpha therapy (TAT) consisting of the PSMA antibody pelgifatamab covalently linked to a macropa chelator and labeled with actinium-225 and compare its efficacy and tolerability with other TATs.

Experimental Design::

The in vitro characteristics and in vivo biodistribution, antitumor efficacy, and tolerability of 225Ac-macropa-pelgifatamab (225Ac-pelgi) and other TATs were investigated in cell line– and patient-derived prostate cancer xenograft models. The antitumor efficacy of 225Ac-pelgi was also investigated in combination with the androgen receptor inhibitor darolutamide.

Results::

Actinium-225-labeling of 225Ac-pelgi was efficient already at room temperature. Potent in vitro cytotoxicity was seen in PSMA-expressing (LNCaP, MDA-PCa-2b, and C4-2) but not in PSMA-negative (PC-3 and DU-145) cell lines. High tumor accumulation was seen for both 225Ac-pelgi and 225Ac-DOTA-pelgi in the MDA-PCa-2b xenograft model. In the C4-2 xenograft model, 225Ac-pelgi showed enhanced antitumor efficacy with a T/Cvolume (treatment/control) ratio of 0.10 compared with 225Ac-DOTA-pelgi, 225Ac-DOTA-J591, and 227Th-HOPO-pelgifatamab (227Th-pelgi; all at 300 kBq/kg) with T/Cvolume ratios of 0.37, 0.39, and 0.33, respectively. 225Ac-pelgi was less myelosuppressive than 227Th-pelgi. 225Ac-pelgi showed dose-dependent treatment efficacy in the patient-derived KuCaP-1 model and strong combination potential with darolutamide in both cell line– (22Rv1) and patient-derived (ST1273) xenograft models.

Conclusions::

These results provide a strong rationale to investigate 225Ac-pelgi in patients with prostate cancer. A clinical phase I study has been initiated (NCT06052306).

2024-03-01·JOURNAL OF CLINICAL ONCOLOGY

Prostate-Specific Membrane Antigen–Targeting Alpha Emitter via Antibody Delivery for Metastatic Castration-Resistant Prostate Cancer: A Phase I Dose-Escalation Study of ²²⁵Ac-J591

Article

作者: Vallabhajosula, Shankar ; Sternberg, Cora N. ; Nanus, David M. ; Ballman, Karla ; Bander, Neil H. ; Sartor, A. Oliver ; Stangl-Kremser, Judith ; Osborne, Joseph R. ; Sun, Michael ; Tagawa, Scott T. ; Molina, Ana ; Nauseef, Jones T. ; Castellanos, Sandra Huicochea ; Bissassar, Mahelia ; Thomas, Charlene

PURPOSE:

Novel therapies are needed to extend survival in metastatic castration-resistant prostate cancer (mCRPC). Prostate-specific membrane antigen (PSMA), a cell surface antigen overexpressed in PC, provides a validated target. This dose-escalation study investigated the safety, efficacy, maximum tolerated dose (MTD), and recommended phase II dose (RP2D) for 225Ac-J591, anti-PSMA monoclonal antibody J591 radiolabeled with the alpha emitter actinium-225.

METHODS:

Following investigational new drug-enabling preclinical studies, we enrolled patients with progressive mCRPC that was refractory to or who refused standard treatment options (including androgen receptor pathway inhibitor and had received or been deemed ineligible for taxane chemotherapy). No selection for PSMA was performed. Patients received a single dose of 225Ac-J591 at one of seven dose-escalation levels followed by expansion at the highest dose. Primary end point of dose-escalation cohort was determination of dose-limiting toxicity (DLT) and RP2D.

RESULTS:

Radiochemistry and animal studies were favorable. Thirty-two patients received 225Ac-J591 in an accelerated dose-escalation design (22 in dose escalation, 10 in expansion). One patient (1 of 22; 4.5%) experienced DLT in cohort 6 (80 KBq/kg) but none in cohort 7; MTD was not reached, and RP2D was the highest dose level (93.3 KBq/kg). The majority of high-grade adverse events (AEs) were hematologic with an apparent relationship with administered radioactivity. Nonhematologic AEs were generally of low grade. Prostate-specific antigen (PSA) declines and circulating tumor cell (CTC) control were observed: 46.9% had at least 50% PSA decline at any time (34.4% confirmed PSA response), and protocol-defined CTC count response occurred in 13 of 22 (59.1%).

CONCLUSION:

To our knowledge, this is the first-in-human phase I dose-escalation trial of a single dose of 225Ac-J591 in 32 patients with pretreated progressive mCRPC demonstrated safety and preliminary efficacy signals. Further investigation is underway.

2023-10-01·The Prostate

Prognostic value of neutrophil-to-lymphocyte ratio in patients with metastatic castration-resistant prostate cancer receiving prostate-specific membrane antigen targeted radionuclide therapy.

Article

作者: Osborne, Joseph R ; Bander, Neil H ; Molina, Ana ; Nauseef, Jones T ; Sun, Michael ; Tagawa, Scott ; Thomas, Joseph ; Stangl-Kremser, Judith ; Ho, Benedict ; Nanus, David M ; Sternberg, Cora N

BACKGROUND:

Neutrophil count:lymphocyte count ratio (NLR) may be a prognostic factor for men with advanced prostate cancer. We hypothesized that it is associated with prostate-specific antigen (PSA) response and survival in men treated with prostate-specific membrane antigen (PSMA)-targeted radionuclide therapy (TRT).

METHODS:

Data of 180 men with metastatic castration-resistant prostate cancer (mCRPC) who were treated in sequential prospective radionuclide clinical trials from 2002 to 2021 (utilizing 177Lu-J591, 90Y-J591, 177Lu-PSMA-617, or 225Ac-J591) were retrospectively analyzed. We used a logistic regression to determine the association between NLR and ≥50% PSA decline (PSA50) and a Cox proportional hazards model to investigate the association between NLR and overall survival (OS).

RESULTS:

A total of 94 subjects (52.2%) received 177Lu-J591, 51 (28.3%) 177Lu-PSMA-617, 28 (15.6%) 225Ac-J591, and 7 (3.9%) 90Y-J591. The median NLR of 3.75 was used as cut-off (low vs. high NLR; n = 90, respectively). On univariate analysis, NLR was not associated with PSA50 (HR 1.08; 95% confidence interval [CI] 0.99-1.17, p = 0.067). However, it was associated with worse OS (hazard ratio [HR] 1.06, 95% CI 1.02-1.09, p = 0.002), also after controlling for circulating tumor cell count and cancer and leukemia group B risk group (HR 1.05; 95% CI 1.003-1.11, p = 0.036). Men with high NLR were at a higher hazard of death from all causes (HR 1.43, 95% CI 1.05-1.94, p = 0.024).

CONCLUSIONS:

NLR provides prognostic information in the setting of patients with mCRPC receiving treatment with PSMA-TRT.

项与 225Ac-J591 相关的新闻（医药）

2024-04-02

·PRNewswire

Convergent Therapeutics Announces FDA Clearance of IND Application for CONV01-α, a Best-in-Class Radioantibody Targeting Prostate-Specific Membrane Antigen

- CONV01-α is an actinium-225 labeled radioantibody with proven efficacy and safety in multiple Phase 1/2 trials in prostate cancer patients - Convergent Therapeutics will conduct Phase 2 clinical trials in 2024 preparing for a registrational program in 2025 CAMBRIDGE, Mass., April 2, 2024 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical stage biotechnology company focused on developing next generation radiopharmaceutical therapies for the treatment of prostate cancer and other cancers, today announced that the U.S. Food and Drug Administration ("FDA") has cleared the investigational new drug ("IND") application for CONV01-α, its lead candidate for the treatment of patients with advanced prostate cancer. "Receiving clearance of our IND is a significant milestone for Convergent Therapeutics," said Convergent's Co-founder and CEO, Philip Kantoff, MD. "While we have already treated well over 100 prostate cancer patients in the context of investigator INDs, this new IND will allow us to rapidly advance CONV01-α into Phase 3 studies and expand the scope of clinical development of CONV01-α as a monotherapy and in combination with other cancer therapies." In a multi-dose, dose escalation study conducted in advanced prostate cancer patients, CONV01-α demonstrated a prostate-specific antigen decline of 50% (PSA50) in 67% of patients and a PSA decline of 90% (PSA90) in 27% of patients and was well tolerated.1 Ongoing studies suggest CONV01-α may be highly effective when used alone or in combination with other cancer therapies. "Importantly, patients also showed minimal side effects in Phase 1/2 trials. CONV01-α's ideal biodistribution delivers potent alpha particles while avoiding immediate and significant salivary gland toxicity as well as the potential delayed renal toxicity," said Neil Bander, MD, Convergent's Co-founder and CSO. "CONV01-α's design increases delivery of tumor-killing radiation to malignant cells while greatly reducing both off-tumor effects and the amount of radiation delivered per dose, thereby improving both treatment efficacy and safety." About CONV01-α CONV01-α, Convergent's alpha emitting radioantibody, combines the precision and pharmacokinetics of antibodies with the tumor-killing potential of alpha emitting radionuclides. Specifically, CONV01-α uses a humanized monoclonal antibody targeted at prostate-specific membrane antigen (PSMA) which is highly overexpressed in prostate cancer cells. Since PSMA is a validated target, several therapeutics are directed at this antigen and CONV01-α is differentiated by its use of both an antibody and alpha emitter. CONV01-α is linked to a powerful radionuclide called 225Ac, which releases alpha particles which kill cancer cells through DNA double strand breaks. Unlike other radioactive sources, alpha particles deliver high-energy radiation over very short distances, thereby minimizing radiation exposure to healthy neighboring cells and tissues. Pairing highly selective antibodies with such a powerful yet precise payload offers the ideal combination to treat many types of cancers. About Convergent Therapeutics, Inc. Convergent Therapeutics Inc. is a clinical-stage biotechnology company focused on developing tumor-selective alpha radioantibodies to target cancer. The company was founded by world-renowned experts in clinical care and research, drug development and cancer biology and its proprietary platform is licensed from Cornell University. In harnessing the selectivity of antibodies and tumor-destructive potential of alpha radioisotopes, Convergent's radioantibodies precisely target cancer cells with potent, localized radiation. For more information, please visit and follow us on Twitter and LinkedIn. 1Nauseef, J. T., et al. Abstract CT014: Phase I dose-escalation study of fractionated dose 225AC J591 for metastatic castration resistant prostate cancer. Cancer Research. 2023: 83(8_Supplement). SOURCE Convergent Therapeutics

放射疗法临床申请

2023-05-25

·PRNewswire

Convergent Therapeutics to Announce Clinical Trial Updates on its Lead Candidate at the American Society of Clinical Oncology (ASCO) Annual Meeting 2023

CAMBRIDGE, Mass., May 25, 2023 /PRNewswire/ -- Convergent Therapeutics Inc., a clinical-stage biotechnology company focused on the development of next-generation radiopharmaceuticals for the treatment of cancer, today announced the title of an upcoming poster presentation on its lead asset, CONV01-α (225Ac-J591), a prostate-specific membrane antigen (PSMA)-targeted monoclonal antibody linked to actinium-225 (225Ac) at the American Society of Clinical Oncology Annual Meeting, which is taking place in Chicago, June 2 – 6. The poster presentation entitled "Phase I dose-escalation results of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT) with alpha-radiolabeled antibody 225Ac-J591 and beta-radioligand 177Lu-PSMA I&T" will be presented by Dr. Scott Tagawa, Professor of Medicine and of Urology, member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and Attending Physician at NewYork-Presbyterian/Weill Cornell Medical Center. Details of the poster presentation are as follows: Abstract Title: Phase I dose-escalation results of prostate-specific membrane antigen-targeted radionuclide therapy (PSMA-TRT) with alpha-radiolabeled antibody 225Ac-J591 and beta-radioligand 177Lu-PSMA I&T Presenter: Dr. Scott Tagawa*, Professor of Medicine and of Urology, member of the Sandra and Edward Meyer Cancer Center at Weill Cornell Medicine and Attending Physician at NewYork-Presbyterian/Weill Cornell Medical Center Date & Time: June 3, 1:15 pm CDT Location: E450 | On Demand Session Type: Poster Discussion Session Session Title: Genitourinary Cancer—Prostate, Testicular, and Penile Clinical Trial Registration Number: NCT04886986 Abstract number: 5018 Poster Bd number: 112 Dr. Tagawa is a paid consultant and equity stakeholder for Convergent Therapeutics and has been a paid consultant for POINT, Sanofi, Medivation, Astellas, Dendreon, Janssen, Genentech, Bayer, Endocyte, Eisai, Immunomedics, Karyopharm, Abbvie, Tolmar, Seattle Genetics, Amgen, Clovis, QED, Pfizer, AAA/Novartis, Clarity, Genomic Health, Blue Earth, Alkido Pharma, Telix Pharma, EMD Serono, Myovant, Merck, and Daiichi Sankyo. About Convergent Therapeutics, Inc. Convergent Therapeutics Inc. is a clinical-stage biotechnology company focused on developing next-generation radiopharmaceutical therapies for prostate and other cancers. The company's proprietary technology was developed by Dr. Neil Bander, the Bernard and Josephine Chaus Professor of Urologic Oncology at Weill Cornell Medicine, and licensed to Convergent by Cornell University. CONV01-α, a monoclonal antibody conjugated to actinium-225 (Ac-225), a radioactive alpha particle emitter, was specifically designed to bind to the prostate-specific membrane antigen (PSMA). A key functional feature of CONV01-α is that once bound to PSMA, it becomes internalized, delivering its powerful radioactive payload directly into prostate cancer cells while minimizing damage to surrounding healthy tissue. CONV01-α has the potential to be the first Ac-225 radioantibody approved for use in prostate cancer treatment. For more information, please visit and follow us on Twitter and LinkedIn. Convergent Media Contact: Rob Haney, Ph.D. Russo Partners, LLC (401) 632-9316 [email protected] SOURCE Convergent Therapeutics

临床1期ASCO会议

2023-05-05

·药明康德

速递 | 近亿美元A轮融资！开发潜在“best-in-class”疗法治疗前列腺癌

Convergent Therapeutics日前宣布完成9000万美元的A轮融资，由OrbiMed和RA Capital Management领投，Invus参与投资。这笔融资将支持公司开发一系列创新放射性抗体药物，包括其针对晚期前列腺癌治疗的先导项目CONV01-α。 Convergent是一家临床阶段的生物技术公司，专注于开发治疗前列腺癌和其他癌症的下一代放射性药物疗法。该公司的专有技术由威尔康奈尔医学院（Weill Cornell Medicine）泌尿肿瘤学教授Neil Bander博士开发，并由康奈尔大学授权给Convergent。CONV01-α是一种与锕-225（Ac-225）结合的单克隆抗体，专为与前列腺特异性膜抗原（PSMA）结合而设计。锕-225是一种放射性α粒子发射器。CONV01-α的一个关键功能特性是，一旦与PSMA结合，它就会被内化，将其强大的放射性有效成分直接送入前列腺癌细胞，同时将对周围健康组织的损害降至最低。CONV01-α有望成为首个获批用于前列腺癌治疗的Ac-225放射性抗体。 “虽然医学界在寻找有效的前列腺癌治疗方法方面已取得相当大的进展，但它仍然是男性癌症死亡的第二大原因，因此代表着一项重大尚未满足的需求，”Convergent首席执行官Philip Kantoff博士表示，“这笔融资对Convergent来说是一个重要的里程碑，加速了从CONV01-α开始的创新放射性抗体药物的开发。我们认为这个项目是针对前列腺癌的潜在‘best-in-class’疗法。我们将在短期内推进CONV01-α的临床开发。自Convergent成立以来，我们的重点一直是汇集世界一流的专业知识，以识别和开发广泛的癌症新型放射性药物治疗。” 参考资料：[1] Convergent Therapeutics Announces $90 Million Series A Financing to Advance the Clinical Development of Radiopharmaceuticals for the Treatment of Prostate Cancer and Other Solid Tumors. Retrieved May 3, 2023 from https://www.prnewswire.com/news-releases/convergent-therapeutics-announces-90-million-series-a-financing-to-advance-the-clinical-development-of-radiopharmaceuticals-for-the-treatment-of-prostate-cancer-and-other-solid-tumors-301813685.html?tc=eml_cleartime 内容来源于网络，如有侵权，请联系删除。

放射疗法基因疗法

100 项与 225Ac-J591 相关的药物交易

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研发状态

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适应症	最高研发状态	国家/地区	公司	日期
转移性去势抵抗性前列腺癌	临床2期	美国	Weill Medical College of Cornell University	2020-08-18

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研究	分期	人群特征	评价人数	分组	结果	评价	发布日期


NCT04946370 (ESMO2024) 人工标引	临床1期	转移性去势抵抗性前列腺癌	12	Pembrolizumab 225Ac-J591	鑰衊簾淵衊積簾鏇蓋獵(壓顧壓構繭糧艱齋繭廠) = determined to be 80 KBq/Kg 觸網廠鹽餘範鏇鑰構積 (選選網淵鑰壓製衊鑰鑰 )	积极	2024-09-15
NCT04946370 (ESMO2024) 人工标引	临床1期	转移性去势抵抗性前列腺癌	12	Pembrolizumab 225Ac-J591		积极	2024-09-15
NCT04886986 (ASCO 12023 \| ASCO 22023) 人工标引	临床1/2期	前列腺癌	18	225Ac-J591+PNT2002	製觸製醖廠築鏇齋餘願(夢選蓋窪製鹹獵遞夢艱) = 2 of 6 pts with DLT at 40 KBq/Kg (Gr 2 or 3 thrombocytopenia delaying cycle 2 by >3 wk); no DLT observed in other cohorts. 夢醖夢齋憲齋餘艱構簾 (廠範艱構憲鹽憲鬱製鹽 ) 更多	积极	2023-05-31
AACR2023 人工标引	临床1期	转移性去势抵抗性前列腺癌	24	225Ac J591	範廠遞廠衊壓齋鑰築壓(鹹製顧夢齋構醖衊製膚) = No DLTs were observed in Cohort 1 (n=3) or 2 (n=6). In C3, 2/6 subjects experienced DLTs 壓遞範獵齋膚餘鑰觸願 (獵餘艱襯範夢構糧衊壓 ) 更多	积极	2023-04-14
NCT04946370 (ASCO_GU2023) 人工标引	临床1/2期	去势抵抗性前列腺癌	13	pembrolizumab+225Ac-J591	襯繭艱壓膚遞艱鑰觸獵(艱醖鹽網積窪淵鑰艱獵) = 9 (75%) thrombocytopenia (3 with g≥3; 1 g4 with PC marrow infiltration), 7 (58%) neutropenia (none g≥3), 6 (50%) nausea, 7 (58%) g1-2 fatigue, 9 (75%) g1-2 xerostomia, 7 (58%) g1 AST 鹹憲構膚積鑰衊遞鬱鹽 (窪齋鏇鹹遞蓋鏇壓鑰齋 ) 更多	积极	2023-02-21
NCT03276572 (Phase I Dose-Escalation Study of <sup>225</sup>Ac-J591, CTgov)	临床1期	转移性去势抵抗性前列腺癌	32	225Ac-J591 (225Ac-J591 Cohort 1)	選顧醖網鹹觸遞遞顧糧(夢觸廠顧壓築鬱糧製廠) = 構製衊鑰糧窪齋蓋積範廠選窪鏇壓夢鬱遞顧糧 (齋範艱憲夢鹽繭簾獵構, 鑰願觸積鏇簾襯選夢鹽 ~ 築鹽網鑰齋鹽選繭糧窪) 更多	-	2022-12-06
	临床1期	转移性去势抵抗性前列腺癌	32	225Ac-J591 (225Ac-J591 Cohort 2)	選顧醖網鹹觸遞遞顧糧(夢觸廠顧壓築鬱糧製廠) = 顧製襯獵鏇糧壓艱淵淵廠選窪鏇壓夢鬱遞顧糧 (齋範艱憲夢鹽繭簾獵構, 鹽遞築積衊網鹹願構窪 ~ 夢範壓廠積鬱鏇憲鹽網) 更多	-	2022-12-06
NCT04506567 (ASCO_GU2021)	临床1/2期	转移性去势抵抗性前列腺癌	-	225Ac-J591 (Fractionated-dose cohort)	淵餘鬱膚鑰糧鏇簾蓋糧(鏇窪淵觸壓憲齋網衊膚) = 築觸積築繭觸窪築廠鏇範齋夢構網願餘齋蓋衊 (鑰鹽窪築鏇獵夢網築願 )	-	2021-03-02
NCT04506567 (ASCO_GU2021)	临床1/2期	转移性去势抵抗性前列腺癌	-	225Ac-J591 (Multiple-dose cohort)	淵餘鬱膚鑰糧鏇簾蓋糧(鏇窪淵觸壓憲齋網衊膚) = 鏇範鏇淵糧糧顧簾鹹選範齋夢構網願餘齋蓋衊 (鑰鹽窪築鏇獵夢網築願 )	-	2021-03-02
NCT03276572 (ASCO2020)	临床1期	转移性去势抵抗性前列腺癌	22	<sup>225</sup>Ac-J591	艱鬱鬱鬱鬱遞衊構顧夢(齋遞淵襯夢製觸膚憲襯) = 製襯壓積壓蓋糧鹽遞遞淵鹽觸蓋糧醖築廠窪憲 (網鏇繭襯願夢積蓋簾遞 ) 更多	积极	2020-05-25