{"id":56263,"date":"2024-06-16T00:03:47","date_gmt":"2024-06-16T00:03:47","guid":{"rendered":"https:\/\/english.saigonbiz.com.vn\/2024\/06\/16\/carsgen-presents-first-in-human-results-of-gprc5d-targeting-car-t-ct071-at-eha-2024\/"},"modified":"2024-06-16T00:03:47","modified_gmt":"2024-06-16T00:03:47","slug":"carsgen-presents-first-in-human-results-of-gprc5d-targeting-car-t-ct071-at-eha-2024","status":"publish","type":"post","link":"https:\/\/english.saigonbiz.com\/vn\/carsgen-presents-first-in-human-results-of-gprc5d-targeting-car-t-ct071-at-eha-2024\/","title":{"rendered":"CARsgen Presents First-in-human Results of GPRC5D Targeting CAR-T CT071 at EHA 2024"},"content":{"rendered":"<div>\n<table name=\"logo_release\" border=\"0\" cellspacing=\"10\" cellpadding=\"5\" align=\"right\">\n<tbody>\n<tr>\n<td><img decoding=\"async\" src=\"https:\/\/mma.prnasia.com\/media2\/1722549\/Logo.jpg?p=medium600\" border=\"0\" alt=\"\" title=\"logo\" hspace=\"0\" vspace=\"0\" width=\"118\"><\/td>\n<\/tr>\n<\/tbody>\n<\/table>\n<p><span class=\"legendSpanClass\"><span class=\"xn-location\">SHANGHAI<\/span><\/span>, <span class=\"legendSpanClass\"><span class=\"xn-chron\">June 15, 2024<\/span><\/span> \/PRNewswire\/ &#8212; CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the initial results from the ongoing first-in-human study of CT071 have been presented at the 29th Annual Congress of the European Hematology Association (EHA).<\/p>\n<div class=\"PRN_ImbeddedAssetReference\" id=\"DivAssetPlaceHolder1\">\n<\/p><\/div>\n<p>The preliminary results of Phase I of CT071 (NCT05838131) were presented as a poster at the 29th EHA Annual Congress on <span class=\"xn-chron\">June 14<\/span>, <span class=\"xn-chron\">18:00 &#8211; 19:00 CEST<\/span>, which was titled &#8220;First-in-human study of GPRC5D-targeted CAR T cells (CT071) with an accelerated manufacturing process in patients with relapsed\/ refractory multiple myeloma (RRMM)&#8221;.<sup>[1]<\/sup><\/p>\n<p>&#8220;Multiple myeloma is a common yet incurable hematologic malignancy with high unmet need. Despite the numerous recent advances, most patients relapse and become refractory to available therapies and therefore, novel therapies are needed. GPRC5D, a protein highly expressed on the surface of malignant plasma cells with limited expression on normal tissues, represents a promising target for treating multiple myeloma. CT071 is a fully human GPRC5D-targeting autologous second-generation CAR T-cell product manufactured using our expedited CARcelerate<sup>TM <\/sup>platform that shortens the manufacturing time to around 30 hours, supporting a shorter vein-to-vein time and younger T cells. The preliminary results of the ongoing study presented at EHA shows that CT071 has the potential to be the best-in-class GPRC5D targeting CAR-T therapy,&#8221; said <span class=\"xn-person\">Raffaele Baffa<\/span>, M.D., Ph.D., Chief Medical Officer of CARsgen Therapeutics. &#8220;We are excited about advancing CT071 and look forward to sharing future updates with the medical community.&#8221;<\/p>\n<p>As of <span class=\"xn-chron\">February 28, 2024<\/span>, 10 patients were dosed with CT071\u20147 patients at 1.0\u00d710<sup>5<\/sup> cells\/kg and 3 patients at 3.0\u00d710<sup>5<\/sup> cells\/kg. Among them, 80% had high-risk cytogenetics, 30% had one or more extramedullary plasmacytomas (EMD), and 40% were at R-ISS stage III. This was a heavily pre-treated population with a median of 5 prior lines of therapy, including 90% double-class refractory, 70% triple-class refractory, 40% penta-drug refractory, 50% having received autologous stem cell transplantation, and 20% had previously been treated with BCMA\/CD19 dual-targeting CAR T cells. None of the patients on the study required bridging therapy due to rapid manufacturing turnaround.<\/p>\n<p>The median follow-up at the time of data cut-off was 4.07 months (range: 2.8-7.4). There were no Grade 3 or higher cytokine release syndrome (CRS) events. No immune effector cell-associated neurotoxicity syndrome (ICANS) was observed. No adverse events of special interest or dose limiting toxicity (DLT) occurred. Four patients experienced treatment-related SAE, including pneumonia (n=1), decreased appetite (n=1) and thrombocytopenia (n=2), and all recovered.<\/p>\n<p>The overall response rate was 90%, including 5 patients (50%) with stringent complete response (sCR), 2 patients (20%) with very good partial response (VGPR), and 2 patients (20%) with partial response (PR). All the 9 patients with evaluable MRD assessment at Week 4 achieved MRD negativity (10<sup>-6<\/sup> threshold) <span>), including all 5 patients with sCR\/CR.<\/span>\u00a0The\u00a0pharmacokinetic analysis demonstrated robust cell expansion and persistence, with median T<sub>max<\/sub> of 14 days (range: 12-28) and median C<sub>max<\/sub> of 32280.5 copies\/\u03bcg gDNA (range: 8372-106060).<\/p>\n<p><b>About CT071<br \/><\/b>CT071 is a CAR T-cell therapy candidate developed utilizing CARsgen&#8217;s proprietary CARcelerate<sup>TM<\/sup> platform targeting GPRC5D for the treatment of R\/R MM or relapsed\/refractory plasma cell leukemia (&#8220;R\/R PCL&#8221;). An investigator-initiated trial (NCT05838131) is ongoing in <span class=\"xn-location\">China<\/span> to evaluate the safety and efficacy of CT071 for the treatment of R\/R MM or R\/R PCL. Another investigator-initiated trial (NCT06407947) is ongoing in <span class=\"xn-location\">China<\/span> for the treatment of newly diagnosed multiple myeloma (NDMM).<\/p>\n<p><b>About CARsgen Therapeutics Holdings Limited<br \/><\/b>CARsgen is a biopharmaceutical company with operations in <span class=\"xn-location\">China<\/span> and the U.S. and is focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors. CARsgen has established a comprehensive CAR T-cell research and development platform, encompassing target discovery, innovative CAR T-cell development, clinical trials, and commercial-scale production. CARsgen has internally developed novel technologies and a product pipeline with global rights to address major challenges of CAR T-cell therapies, such as improving the safety profile, enhancing the efficacy in treating solid tumors, and reducing treatment costs. CARsgen&#8217;s mission is to become a global biopharmaceutical leader that brings innovative and differentiated cell therapies to cancer patients worldwide and makes cancer curable.<\/p>\n<p><b>Forward-looking Statements<br \/><\/b>All statements in this press release that are not historical fact or that do not relate to present facts or current conditions are forward-looking statements. Such forward-looking statements express the Group&#8217;s current views, projections, beliefs and expectations with respect to future events as of the date of this press release. Such forward-looking statements are based on a number of assumptions and factors beyond the Group&#8217;s control. As a result, they are subject to significant risks and uncertainties, and actual events or results may differ materially from these forward-looking statements and the forward-looking events discussed in this press release might not occur. Such risks and uncertainties include, but are not limited to, those detailed under the heading &#8220;Principal Risks and Uncertainties&#8221; in our most recent annual report and interim report and other announcements and reports made available on our corporate website, <a href=\"https:\/\/www.carsgen.com\/\" target=\"_blank\" rel=\"nofollow noopener\">https:\/\/www.carsgen.com<\/a>. No representation or warranty is given as to the achievement or reasonableness of, and no reliance should be placed on, any projections, targets, estimates or forecasts contained in this press release.<\/p>\n<p><b>Reference<br \/><\/b>[1] J Du, et al. EHA 2024. 2024 Jun; Poster P941<\/p>\n<p>\u00a0<\/p>\n<\/div>\n","protected":false},"excerpt":{"rendered":"<p>SHANGHAI, June 15, 2024 \/PRNewswire\/ &#8212; CARsgen Therapeutics Holdings Limited (Stock Code: 2171.HK), a company focused on innovative CAR T-cell therapies for the treatment of hematologic malignancies and solid tumors, announces that the initial results from the ongoing first-in-human study of CT071 have been presented at the 29th Annual Congress of the European Hematology Association [&#8230;]\n","protected":false},"author":1,"featured_media":85254,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[],"class_list":["post-56263","post","type-post","status-publish","format-standard","has-post-thumbnail","hentry","category-pr-newswire"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v21.6 (Yoast SEO v21.6) - https:\/\/yoast.com\/wordpress\/plugins\/seo\/ -->\n<title>CARsgen Presents First-in-human Results of GPRC5D Targeting CAR-T CT071 at EHA 2024 - 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