{"id":22080,"date":"2023-02-14T16:32:00","date_gmt":"2023-02-14T08:32:00","guid":{"rendered":"https:\/\/flcube.com\/?p=22080"},"modified":"2025-01-19T16:34:40","modified_gmt":"2025-01-19T08:34:40","slug":"gracell-biotechnologies-gains-ind-approval-for-gc012f-in-china","status":"publish","type":"post","link":"https:\/\/flcube.com\/?p=22080","title":{"rendered":"Gracell Biotechnologies Gains IND Approval for GC012F in China"},"content":{"rendered":"\n<p>Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. The dual BCMA\/CD19-targeted therapy is set to be assessed in treating relapsed\/refractory multiple myeloma (r\/r MM), marking a significant step in the development of innovative treatments for this condition.<\/p>\n\n\n\n<p><strong>Clinical Study Plans<\/strong><br>The Shanghai-based biotech plans to initiate a single-arm, open, multi-center Phase I\/II clinical study in China during the third quarter of this year. With IND approval already obtained in the United States in March, the company expects to kick off a Phase Ib\/II clinical study for the drug with the same indication in the US during the second quarter of this year.<\/p>\n\n\n\n<p><strong>GC012F: Autologous CAR-T Therapy<\/strong><br>GC012F is an autologous CAR-T therapy developed on Gracell\u2019s award-winning FasTCAR manufacturing platform, which enables a 24-hour treatment turnaround. This rapid turnaround time is a significant advantage in the treatment of multiple myeloma, where timely intervention can be critical.<\/p>\n\n\n\n<p><strong>Regulatory and Clinical Milestones<\/strong><br>The therapy was awarded an orphan drug designation from the US FDA for its potential against MM in November 2021. Gracell is currently assessing the candidate in multiple investigator-initiated trials (IIT) for indications including newly diagnosed MM and B-cell non-Hodgkin&#8217;s lymphoma. At the European Hematology Association 2022 Hybrid Congress, Gracell presented longer-term follow-up clinical data of GC012F in r\/r MM, which showed a 100% minimal residual disease (MRD) negativity rate in all patients treated. This data highlights the potential of GC012F to significantly improve outcomes for patients with multiple myeloma.<a href=\"https:\/\/flcube.com\/\">-Fineline Info &amp; Tech<\/a><\/p>\n","protected":false},"excerpt":{"rendered":"<p>Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug&#8230;<\/p>\n","protected":false},"author":1,"featured_media":0,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"googlesitekit_rrm_CAownpewDA:productID":"","_jetpack_memberships_contains_paid_content":false,"footnotes":"","jetpack_publicize_message":"","jetpack_publicize_feature_enabled":true,"jetpack_social_post_already_shared":false,"jetpack_social_options":{"image_generator_settings":{"template":"highway","default_image_id":0,"font":"","enabled":false},"version":2}},"categories":[7,11],"tags":[16,21,77,62,644],"class_list":["post-22080","post","type-post","status-publish","format-standard","hentry","category-company","category-drug","tag-cancer","tag-car-t","tag-cell-therapy","tag-clinical-trial-approval-initiation","tag-gracell-biotechnologies"],"yoast_head":"<!-- This site is optimized with the Yoast SEO Premium plugin v23.6 (Yoast SEO v27.5) - https:\/\/yoast.com\/product\/yoast-seo-premium-wordpress\/ -->\n<title>Gracell Biotechnologies Gains IND Approval for GC012F in China - Insight, China&#039;s Pharmaceutical Industry<\/title>\n<meta name=\"description\" content=\"Gracell Biotechnologies has reported receiving Investigational New Drug (IND) approval from the Center for Drug Evaluation (CDE) for its chimeric antigen receptor (CAR) T cell candidate GC012F. 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