A Phase 1/2a, Open-label, Dose-escalation, Dose-expansion, Parallel Assignment Study to Evaluate the Safety and Clinical Activity of PBCAR20A in Subjects With Relapsed/Refractory (r/r) Non-Hodgkin Lymphoma (NHL) or r/r Chronic Lymphocytic Leukemia (CLL) or Small Lymphocytic Lymphoma (SLL)

This is a Phase 1/2a, nonrandomized, open-label, parallel assignment, single-dose, dose-escalation, and dose-expansion study to evaluate the safety and clinical activity of PBCAR20A in adult subjects with r/r B-cell NHL or r/r CLL/SLL.

开始日期2020-03-24

申办/合作机构

Precision BioSciences, Inc.

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100 项与 Allogeneic anti-CD20 CAR-T cell therapy(Precision BioSciences, Inc.) 相关的专利（医药）

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项与 Allogeneic anti-CD20 CAR-T cell therapy(Precision BioSciences, Inc.) 相关的文献（医药）

2023-09-01·Molecular therapy oncolytics

Development of a bicistronic anti-CD19/CD20 CAR construct including abrogation of unexpected nucleic acid sequence deletions

Article

作者: Andrade, Jorge ; Lam, Norris ; Cutmore, Lauren ; Amatya, Christina ; Huang, Lei ; Wu, Xiaolin ; Finney, Richard ; Cam, Margaret ; Yang, Shicheng ; Choi, Stephanie ; Kochenderfer, James N

To address CD19 loss from lymphoma after anti-CD19 chimeric antigen receptor (CAR) T cell therapy, we designed a bicistronic construct encoding an anti-CD19 CAR and an anti-CD20 CAR. We detected deletions from the expected bicistronic construct sequence in a minority of transcripts by mRNA sequencing. Loss of bicistronic construct transgene DNA was also detected. Deletions of sequence were present at much higher frequencies in transduced T cell mRNA versus gamma-retroviral vector RNA. We concluded that these deletions were caused by intramolecular template switching of the reverse transcriptase enzyme during reverse transcription of gamma-retroviral vector RNA into transgene DNA of transduced T cells. Intramolecular template switching was driven by repeated regions of highly similar nucleic acid sequence within CAR sequences. We optimized the sequence of the bicistronic CAR construct to reduce repeated regions of highly similar sequences. This optimization nearly eliminated sequence deletions. This work shows that repeated regions of highly similar nucleic acid sequence must be avoided in complex CAR constructs. We further optimized the bicistronic construct by lengthening the linker of the anti-CD20 single-chain variable fragment. This modification increased CD20-specific interleukin-2 release and reduced CD20-specific activation-induced cell death. We selected an optimized anti-CD19/CD20 bicistronic construct for clinical development.

2022-10-01·Cytotherapy

CD20-specific chimeric antigen receptor-expressing T cells as salvage therapy in rituximab-refractory/relapsed B-cell non-Hodgkin lymphoma

Article

作者: Tan, Jingwen ; Xiao, Han ; Wang, Erhua ; Cheng, Qian ; Li, Ying ; Li, Xin ; Zhang, Jian ; Zhang, Yi ; Li, Minghao ; Xu, Nan ; Liu, Rui ; Yu, Lei ; Kang, Liqing

BACKGROUND AIMS:

The infusion of chimeric antigen receptor (CAR) T cells that target specific tumor-associated antigens is a promising strategy that has exhibited encouraging results in clinical trials. However, few studies have focused on the effectiveness and safety of CD20 CAR T cells in rituximab-refractory/relapsed (R/R) B-cell non-Hodgkin lymphoma (B-NHL) patients, particularly those treated with rituximab for a short time. This prospective study aimed to assess the effectiveness and toxicity of CD20 CAR T cells in R/R B-NHL patients previously treated with rituximab.

METHODS:

The authors conducted a prospective, single-center phase I study on the effectiveness and toxicity of CD20 CAR T cells in rituximab-treated R/R B-NHL patients (no. ChiCTR2000036350). A total of 15 patients with R/R B-NHL were enrolled between November 21, 2017, and December 1, 2021.

RESULTS:

An overall response rate of 100% was shown in enrolled patients, with 12 (80%) achieving complete remission and three (20%) achieving partial remission for the best response. The median follow-up time was 12.4 months. Progression-free survival and overall survival were not yet reached by the data cutoff day. No patient developed grade 4 cytokine release syndrome, and only one patient had immune effector cell-associated neurotoxicity syndrome.

CONCLUSIONS:

All enrolled B-NHL patients who were previously R/R to rituximab achieved different degrees of clinical response with tolerable toxicities. Notably, patients who had received rituximab within 3 months had a poorer prognosis.

2022-06-01·Journal for immunotherapy of cancer

Development of anti-somatostatin receptors CAR T cells for treatment of neuroendocrine tumors

Article

作者: Pellè, Eleonora ; Abate-Daga, Daniel ; Ramello, Maria Cecilia ; Mannavola, Francesco ; Palazzo, Antonio ; Strosberg, Jonathan ; Cives, Mauro ; Porta, Camillo ; Mandriani, Barbara ; Ingravallo, Giuseppe ; Cazzato, Gerardo ; Marsano, Renè Massimiliano

Background:

Neuroendocrine tumors (NETs) overexpress somatostatin receptors (SSTRs).

Methods:

We developed a second-generation, ligand-based, anti-SSTR chimeric antigen receptor (CAR) incorporating the somatostatin analog octreotide in its extracellular moiety.

Results:

Anti-SSTR CAR T cells exerted antitumor activity against SSTR+NET cell linesin vitro. The killing activity was highly specific, as demonstrated by the lack of CAR T cell reactivity against NET cells engineered to express mutated variants of SSTR2/5 by CRISPR/Cas9. When adoptively transferred in NSG mice, anti-SSTR CAR T cells induced significant antitumor activity against human NET xenografts. Although anti-SSTR CAR T cells could recognize the murine SSTRs as shown by their killing ability against murine NET cells, no obvious deleterious effects on SSTR-expressing organs such as the brain or the pancreas were observed in mice.

Conclusions:

Taken together, our results establish anti-SSTR CAR T cells as a potential candidate for early phase clinical investigations in patients with NETs. More broadly, the demonstration that a known peptide drug can direct CAR T cell targeting may streamline the potential utility of multiple peptide motifs and provide a blueprint for therapeutic applications in a variety of cancers.

项与 Allogeneic anti-CD20 CAR-T cell therapy(Precision BioSciences, Inc.) 相关的新闻（医药）

2022-11-07

·PRNewswire

CAR T-cell Therapy Pipeline Analysis Demonstrates 450+ Novel Therapies at the Horizon Expected to Transform the Treatment Paradigm | DelveInsight

CAR T-cell therapy clinical trial pipeline constitutes 193+ key companies continuously working towards developing 450+ CAR T-cell therapies, analyzes DelveInsight LAS VEGAS, Nov. 7, 2022 /PRNewswire/ -- DelveInsight's ' CAR T-cell Therapy Competitive Landscape – 2022 ' report provides comprehensive global coverage of available, marketed, and pipeline CAR T-cell therapies in various stages of clinical development, major pharmaceutical companies are working to advance the pipeline space and future growth potential of the CAR T-cell therapy competitive domain. Key Takeaways from the CAR T-cell Therapy Pipeline Report Over 193+ CAR T companies are evaluating 450+ CAR T-cell therapies in various stages of development, and their anticipated acceptance in the CAR T-cell therapy market would significantly increase market revenue. Leading CAR T companies such as Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others are evaluating novel CAR T-cell Therapy drugs candidate to improve the treatment landscape. Key CAR T pipeline therapies in various stages of development include Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. In May 2022, Novartis announced the US Food and Drug Administration (FDA) had granted accelerated approval for Kymriah (tisagenlecleucel) for the treatment of adult patients with relapsed or refractory (r/r) follicular lymphoma (FL) after two or more lines of systemic therapy. Kymriah is now FDA-approved in three indications and remains the only CAR-T cell therapy approved in both adult and pediatric settings. In April 2022, the FDA approved axicabtagene ciloleucel (brand name Yescarta) for adult patients with large B-cell lymphoma that is refractory to first-line chemoimmunotherapy or relapses within 12 months of first-line chemoimmunotherapy. It is not indicated for treating patients with primary central nervous system lymphoma. In March 2022, JW Therapeutics announced that it had received the Investigational New Drug (IND) clearance from the National Medical Products Administration (NMPA) of China for a pivotal clinical trial of its anti-CD19 autologous chimeric antigen receptor T (CAR-T) cell immunotherapy product Carteyva (relmacabtagene autoleucel injection) in the treatment of second-line large B-Cell lymphoma. In February 2022, Fully human anti-B-cell maturation antigen (BCMA) chimeric antigen receptor (CAR) T-cell therapy (CT103A) received orphan drug designation (ODD) from the FDA for the treatment of relapsed and/or refractory multiple myeloma (R/R MM), according to a press release by IASO Biotherapeutics. In June 2021, based on ZUMA-3 study data, the US FDA accepted the supplemental Biologics License Application (sBLA) and granted Priority Review designation for Tecartus for the treatment of adult patients with relapsed or refractory B-cell precursor ALL. In April 2021, the Janssen Pharmaceutical Companies of Johnson & Johnson announced that they had submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) seeking approval of cilta-cel for the treatment of patients with relapsed and refractory multiple myeloma. In March 2021, the FDA approved Abecma (idecabtagene vicleucel), a cell-based CAR T - Cell Therapy to treat adult patients with multiple myeloma who have not responded to or whose disease has returned after at least four prior lines (different types) of therapy. Abecma is the first cell-based CAR T - Cell Therapy approved by the FDA for treating multiple myeloma. Request a sample and discover the recent advances in CAR T therapies @ CAR T-cell Therapy Competitive Landscape Report CAR T-cell Therapy Overview Chimeric antigen receptors (CARs) are recombinant antigen receptors that redirect the specificity and function of T lymphocytes and other immune cells in a single molecule. Cancer Immunotherapy is one of the most promising approaches for treating severe diseases (including cancer, autoimmune diseases, and allergic-hypersensitivity reactions) because it uses and improves the immune system's standard capacity. CAR T-cells are proteins that are fusions of a specific monoclonal antibody's single-chain fragment variable and one or more T-cell receptor intracellular signaling domains. A CAR combines antigen-binding domains—most commonly, a single-chain variable fragment (scFv) derived from antibody variable domains—with TCR chain signaling domains and costimulatory domains from receptors such as CD28, OX40, and CD137. For more information about CAR T-cell therapy drugs; visit @ CAR T-cell Therapy Process CAR T-cell Therapy Pipeline Analysis: Drug Profile JWCAR029: JW Therapeutics JW Therapeutics drug JWCAR029 is a CAR-T cell product that targets CD19 and is intended to treat advanced lymphoma and leukemia (Second-line therapy or greater). The molecule is currently in phase II of development. JWCAR029 is initially being investigated for the treatment of B-cell malignancies, with a focus on relapsed and refractory DLBCL. The National Medical Products Administration ("NMPA") accepted for review its NDA for relma-cel as a third-line treatment for DLBCL in June 2020. KTE-X19: Gilead Sciences Gilead Sciences drug KTE-X19 is an autologous CD19 CAR T-cell therapy under investigation. The drug is manufactured using the XLP process, including T-cell selection and lymphocyte enrichment. Lymphocyte enrichment is required in certain B-cell malignancies for which KTE-X19 is being studied. KTE-X19 is currently in Phase II clinical trials for the treatment of both adult and pediatric acute lymphocytic leukemia. Brexucabtagene autoleucel (formerly KTE-X19; Tecartus) has been approved by the FDA for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (MCL). A snapshot of the CAR T-cell Therapy Pipeline Drugs mentioned in the report: Learn more about FDA approved CAR T-cell therapy @ CAR T Clinical Trials Scope of the CAR T-cell Therapy Competitive Landscape Report Coverage: Global Key CAR T-cell Therapy Companies: Alnylam Pharmaceuticals, JW Therapeutics, Gilead Sciences, Janssen Pharmaceuticals, Innovent Biologics, Sorrento Therapeutics, Cartesian Therapeutics, CASI Pharmaceuticals, Juventas Cell Therapy, Novartis, Poseida Therapeutics,Shanghai Unicar-Therapy Bio-medicine Technology, Sinobioway Cell Therapy Co., Ltd., Tessa Therapeutics, Wuhan Bio-Raid Biotechnology, Miltenyi Biomedicine, Bristol-Myers Squibb, Autolus Limited, Beijing Immunochina Medical Science and Technology, Carsgen Therapeutics, Cellular Biomedicine Group, Chongqing Precision Biotech, Eureka Therapeutics, Formula Pharmaceuticals, Guangzhou Bio-gene Technology, Hebei Senlang Biotechnology, Mustang Bio, MolMed, Aurora BioPharma, Atara Biotherapeutics, Autolus, Bellicum Pharmaceuticals, Kecellitics Biotech Company Ltd, Yake Biotechnology, Minerva Biotechnologies, Allogene Therapeutics, PersonGen BioTherapeutics (Suzhou), Precision BioSciences, Pregene (ShenZhen) Biotechnology Company, Shanghai GeneChem, Shanghai Longyao Biotechnology, Shenzhen BinDeBio, and others Key CAR T-cell Therapies in Pipeline: Breyanzi, Kymriah, CT103A, CEA CAR-T, Descartes-11, CNCT19, CTL119, P-BCMA-101, CD19/CD20/CD22/CD30 CAR T-cell therapy, CD19-targeted CAR T-cells, EPCAM-targeted CAR-T cells, TT11, CD19+CD22 CAR-T cell sequential therapy, CART-19/22, MB-CART2019.1, JCAR017, AUTO4, AUTO3, IM19 CAR-T, CSG-CD19, CT053, Descartes-08, Orvacabtagene autoleucel, CAR-T CD30, PCAR-19B, BCMA CAR-T cells, CD123 CAR-T cells, CD19 CAR-T cells, ET140202, CIK-CAR.CD19, BG-T19, Autologous CD19-targeting CAR T cells (Senl-001), MB-102, Autologous CAR-T CD44v6 cell therapy, AU101, ATA2271, AU105, AUTO1, BPX-601, Anti-CD22 CAR, CAR-T cells targeting CD19 and CD22, huMNC2-CAR44 CAR T-cells, CD19-CART, ALLO-501A, AUTO1/22, ET 1402L1-CART, BPX-603, CAR-CD44v6, MB-106 (CD20 CAR), Anti-MUC1 CAR-T cells, PCAR-019, PBCAR0191, PBCAR20A, PBCAR269A, BCMA CAR T-cells, CAR19 CAR T cells, MG7-CART Cells, GPC3 – CART Cells, Anti-CD19 and Anti-CD20 CAR-T Cells, Humanized CD19 CAR-T cells, Dual Specificity CD19 and CD22 CAR-T Cell Immunotherapy, Mesothelin CAR-T cell therapy, and others. Dive deep into rich insights for CAR T-cell therapy drugs; visit @ FDA-approved CAR T-cell Therapy Table of Contents For further information on the CAR T-cell therapy pipeline therapeutics, reach out @ CAR T-cell Therapy Clinical Trials Related Reports CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market CAR T-cell Therapy for Acute Lymphoblastic Leukemia Market Insights, Epidemiology, and Market Forecast – 2032 report deliver an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Market CAR T-cell Therapy for Multiple Myeloma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market CAR T-cell Therapy for Non-Hodgkin's Lymphoma Market Insights, Epidemiology, and Market Forecast – 2032 report delivers an in-depth understanding of the disease, historical and forecasted epidemiology, as well as the market trends, market drivers, market barriers, and key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline CAR T-cell Therapy for Acute Lymphoblastic Leukemia Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for acute lymphoblastic leukemia companies, including Autolus, Pepromene Bio, Actinium Pharmaceuticals, among others. CAR T-cell Therapy for Multiple Myeloma Pipeline CAR T-cell Therapy for Multiple Myeloma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for multiple myeloma companies, including Novartis, Yake Biotech, Celgene Corporation, among others. CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline CAR T-cell Therapy for Non-Hodgkin's Lymphoma Pipeline Insight – 2022 report provides comprehensive insights about the pipeline landscape, pipeline drug profiles, including clinical and non-clinical stage products, and the key CAR T-cell therapy for non-Hodgkin's lymphoma companies, including Juno Therapeutics, Allogene Therapeutics, Caribou Biosciences, among others. Other Trending Reports Goitre Market | Thymus Cancer Market | US Healthcare Outlook Report | Venous Stenosis Market | Negative Pressure Wound Therapy Systems Market | Global Kinase Inhibitor in Autoimmune Diseases Market | Metrorrhagia Market | Dysfunctional Uterine Bleeding Market | Hypereosinophilic Syndrome Market | Age-related Vision Dysfunction Market | Dental Lasers Market | CRISPR Therapies Pipeline Insight | Cell And Gene Therapy For Multiple Myeloma Market | Drug Hypersensitivity Market | Dysthymia Market | Persistent Depressive Disorder Market | Cancer Vaccines Market | Weight Loss/Weight Management (Obesity) Market | Food Allergy Market | Obsessive-Compulsive Disorder Market | Tumor Ablation Market | Physiotherapy Equipment Market | Chimeric Antigen Receptor (CAR) T-Cell Therapy Market | Anti-hypertension Market | Radiofrequency Ablation Devices Market | Global Messenger RNA (mRNA)-based Vaccines and Therapeutics Market | Gastro Intestinal Bleeding Market | Trastuzumab Biosimilars Insight | Varicose Veins Market | Germ Cell Tumor Market | Intracardiac Echocardiography Devices Market | India Healthcare Report | Crows Feet Market | Seborrhoeic Dermatitis Market | Injectable Drug Delivery Devices Market | Structural Heart Devices Market | Substance (Drug) Abuse Market | Insulin Glargine Biosimilar Insight About DelveInsight DelveInsight is a leading Business Consultant, and Market Research firm focused exclusively on life sciences. Connect with us at LinkedIn Contact Us Shruti Thakur [email protected] +1(919)321-6187 Logo: SOURCE DelveInsight Business Research, LLP

基因疗法抗体孤儿药生物类似药细胞疗法

100 项与 Allogeneic anti-CD20 CAR-T cell therapy(Precision BioSciences, Inc.) 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
B细胞淋巴瘤	临床2期	美国	Precision BioSciences, Inc.	2020-03-24
难治性非霍奇金淋巴瘤	临床2期	美国	Precision BioSciences, Inc.	2020-03-24
复发性慢性淋巴细胞白血病	临床2期	美国	Precision BioSciences, Inc.	2020-03-24
复发性非霍奇金淋巴瘤	临床2期	美国	Precision BioSciences, Inc.	2020-03-24
小淋巴细胞淋巴瘤	临床2期	美国	Precision BioSciences, Inc.	2020-03-24

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分期

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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


NCT04030195 (CTgov)	临床1/2期	难治性非霍奇金淋巴瘤 \| 复发性非霍奇金淋巴瘤 \| B细胞淋巴瘤 ... 更多	18	PBCAR20A+Fludarabine+CYCLOPHOSPHAMIDE (Dose Level 1 of PBCAR20A CAR T Cells)	齋網築醖鑰遞艱願積蓋(鹹範鹹鹽積鏇醖膚衊獵) = 艱憲簾醖鬱鏇衊餘遞網衊淵選壓憲夢遞窪襯繭 (醖鏇鬱糧選憲繭壓築膚, 淵繭積網蓋淵淵願膚糧 ~ 夢壓願淵觸繭襯壓選糧) 更多	-	2023-01-31
				PBCAR20A+Fludarabine+CYCLOPHOSPHAMIDE (Dose Level 2 of PBCAR20A CAR T Cells)	齋網築醖鑰遞艱願積蓋(鹹範鹹鹽積鏇醖膚衊獵) = 壓鹹願鬱壓製網簾積憲衊淵選壓憲夢遞窪襯繭 (醖鏇鬱糧選憲繭壓築膚, 夢願遞顧願淵襯鏇壓糧 ~ 積醖壓鹽淵繭願觸製糧) 更多