{"id":17802,"date":"2023-04-17T20:15:00","date_gmt":"2023-04-17T20:15:00","guid":{"rendered":"https:\/\/www.prnasia.com\/story\/archive\/4072226_AE72226_0"},"modified":"2023-04-17T20:15:00","modified_gmt":"2023-04-17T20:15:00","slug":"shanghai-cellular-biopharmaceutical-group-presents-first-data-from-phase-i-trial-evaluating-a-novel-car-t-in-advanced-liver-cancer-at-aacr-annual-meeting","status":"publish","type":"post","link":"https:\/\/transmediavictoria.net.au\/?p=17802","title":{"rendered":"Shanghai Cellular Biopharmaceutical Group presents first data from Phase I trial evaluating a novel CAR-T in advanced liver cancer at AACR Annual Meeting"},"content":{"rendered":"
\n

Promising anti-tumor activity reported for C-CAR031, a novel Glypican 3 (GPC3)-targeting cell therapy designed by AstraZeneca<\/i><\/b><\/p>\n

SHANGHAI<\/span>, April 18, 2023<\/span> \/PRNewswire\/ — Shanghai Cellular Biopharmaceutical Group Ltd. (the Company, or Shanghai Cellular Bio), a company engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today presented data from the First-in-Human (FIH) Phase I trial evaluating C-CAR031 at the 2023 American Association for Cancer Research (AACR) Annual Meeting.<\/p>\n

Early results indicate that C-CAR031 is well tolerated with promising anti-tumor activity seen and objective responses in several patients to date, including 3 patients with confirmed partial responses, 2 with stable disease and 1 with progressive disease per both RECIST v1.1 and mRECIST criteria. The clinical responses of the patients who achieved partial responses are ongoing up to the data cutoff date.<\/p>\n

C-CAR031 is an autologous GPC3-directed second generation armored CAR-T with affinity-tuned single-chain variable fragment (scFv) to enhance its  safety profile, based on a novel cell therapy designed by AstraZeneca (LSE\/STO\/Nasdaq:AZN) using their TGF\u03b2RII dominant negative armoring discovery platform.<\/p>\n

To investigate the feasibility, safety and initial efficacy of C-CAR301 in hepatocellular carcinoma (HCC), Shanghai Cellular Bio is currently conducting a Phase I FIH clinical study (NCT05155189) in advanced HCC in The First Affiliated Hospital, Zhejiang University School of Medicine in Hangzhou, China<\/span>.<\/p>\n

Methods<\/b>: This FIH, open-label dose escalation trial employs an accelerated dose titration plus i3+3 design. Histologically confirmed GPC3+ advanced HCC patients (pts) who failed systemic treatments received a single-dose i.v.<\/i> infusion of C-CAR031 following standard lymphodepletion. The primary objective was to assess the safety and tolerability. Adverse events (AEs) were graded using CTCAE 5.0, and cytokine release syndrome (CRS) \/ immune effector cell-associated neurotoxicity syndrome (ICANS) were graded according to ASTCT 2019 criteria.<\/p>\n

Results<\/b>: As of March 2<\/span>nd<\/sup>, 2023, seven patients received two dose levels (DL1, n=1; DL2, n=6) of C-CAR031. The median number of prior lines of therapies was 4 (range 1-6). The median follow-up was 77 (67-213) days. Seven patients with \u226528 days’ follow-up were eligible for safety evaluation. Good safety profile was observed at explored dose levels.  86% (6\/7) patients experienced Gr1\/2 CRS; no Dose Limiting Toxicities (DLT) or ICANS was observed. The \u2265Gr3 non-hematologic product-related AE included transient Gr3 AST elevation (2\/7, 28%), hypokalemia (1\/7, 14%), and abdominal pain (1\/7,14%). 5\/6 (83%) patients at DL2 showed tumor shrinkage post C-CAR031 treatment (median -41.4% range -3.4%~ – 94.4%).  Best clinical responses at DL2 included 3 confirmed PR, 2 SD and 1 PD per both RECIST v1.1 and mRECIST. The clinical responses of the patients who achieved PR are ongoing up to the cutoff date. C-CAR031 showed a robust cellular kinetic profile. CAR-T cells were detectable in blood of all patients in the last follow-up.<\/p>\n

Conclusion<\/b>: In this FIH study, C-CAR031 is well tolerated and shows promising anti-tumor activity. Enrollment is ongoing to confirm initial results.<\/p>\n

About <\/i><\/b>Shanghai Cellular Biopharmaceutical Group Ltd<\/i><\/b><\/p>\n

Shanghai Cellular Biopharmaceutical Group Ltd develops proprietary cell therapies for the treatment of cancerous diseases and autoimmune diseases, and operates state-of-the-art research and GMP facility in Shanghai<\/span>, China.   Shanghai Cellular Bio partners with its affiliate in Maryland<\/span> to augment its global research and development capabilities. Shanghai Cellular Bio and its affiliate conduct multiple clinical studies comprised of C-CAR039 Phase 1b<\/span> trial, C-CAR066  targeting treatment for r\/r NHL, C-CAR088, an autologous anti-B cell maturation antigen (BCMA) CAR-T for r\/r myeloma (MM), C-CAR031, an autologous armored anti-GPC3 CAR-T for Hepatocellular carcinoma (HCC), C-TIL051, an autologous tumor-infiltrating lymphocytes (TIL) therapy for non-small cell lung cancer (NSCLC);  and continue to discover and develop multiple novel T cell therapies for solid tumor and for orphan autoimmune diseases.<\/i><\/p>\n

Company Contact:
<\/b>Sarah Kelly<\/span>
Communications & Investor Relations
Shanghai Cellular Biopharmaceutical Group Ltd.
Phone: +86 21 5406 9990
Email: s.kelly@shcellbio.com<\/a><\/p>\n<\/p><\/div>\n

Source: Shanghai Cellular Biopharmaceutical Group Ltd.<\/p>\n","protected":false},"excerpt":{"rendered":"

Promising anti-tumor activity reported for C-CAR031, a novel Glypican 3 (GPC3)-targeting cell therapy designed by AstraZeneca SHANGHAI, April 18, 2023 \/PRNewswire\/ — Shanghai Cellular Biopharmaceutical Group Ltd. (the Company, or Shanghai Cellular Bio), a company engaged in the drug development of immunotherapies for cancer and stem cell therapies for degenerative diseases, today presented data from the […]<\/p>\n","protected":false},"author":8,"featured_media":0,"comment_status":"closed","ping_status":"closed","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[20],"tags":[],"class_list":["post-17802","post","type-post","status-publish","format-standard","hentry","category-business-news"],"yoast_head":"\nShanghai Cellular Biopharmaceutical Group presents first data from Phase I trial evaluating a novel CAR-T in advanced liver cancer at AACR Annual Meeting - My Blog<\/title>\n<meta name=\"robots\" content=\"index, follow, max-snippet:-1, max-image-preview:large, max-video-preview:-1\" \/>\n<link rel=\"canonical\" href=\"https:\/\/transmediavictoria.net.au\/?p=17802\" \/>\n<meta property=\"og:locale\" content=\"en_US\" \/>\n<meta property=\"og:type\" content=\"article\" \/>\n<meta property=\"og:title\" content=\"Shanghai Cellular Biopharmaceutical Group presents first data from Phase I trial evaluating a novel CAR-T in advanced liver cancer at AACR Annual Meeting - My Blog\" \/>\n<meta property=\"og:description\" content=\"Promising anti-tumor activity reported for C-CAR031, a novel Glypican 3 (GPC3)-targeting cell therapy designed by AstraZeneca SHANGHAI, April 18, 2023 \/PRNewswire\/ — Shanghai Cellular Biopharmaceutical Group Ltd. 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