{"id":493495,"date":"2024-01-22T10:26:25","date_gmt":"2024-01-22T15:26:25","guid":{"rendered":"https:\/\/platohealth.ai\/early-phase-trial-shows-promise-of-car-t-cell-therapy-for-pancreatic-gastric-cancers\/"},"modified":"2024-01-22T13:56:23","modified_gmt":"2024-01-22T18:56:23","slug":"early-phase-trial-shows-promise-of-car-t-cell-therapy-for-pancreatic-gastric-cancers","status":"publish","type":"post","link":"https:\/\/platohealth.ai\/early-phase-trial-shows-promise-of-car-t-cell-therapy-for-pancreatic-gastric-cancers\/","title":{"rendered":"Early Phase Trial Shows Promise of CAR T-Cell Therapy for Pancreatic, Gastric Cancers","gt_translate_keys":[{"key":"rendered","format":"text"}]},"content":{"rendered":"
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Image credit: AIGen | stock.adobe.com<\/p>\n<\/div>\n<\/div>\n

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CARsgen Therapeutics Holdings Limited, an organization working with chimeric antigen receptor (CAR) T-cell therapies for the treatment of hematologic malignancies and solid tumors, provided an update on its study of satri-cel (satricabtagene autoleucel, CT041) at the 2024 American Society of Clinical Oncology Gastrointestinal Cancers Symposium (ASCO GI). The data includes the results of a trial on the dose escalation results of satri-cell for patients suffering from gastric\/gastroesophageal (GC\/GEJ) or pancreatic cancer (PC).1<\/sup><\/p>\n

“The treatment options for advanced GC\/GEJ or PC patients are limited. The data we presented at the 2024 ASCO GI of the Phase 1b ELIMYN18.2 study demonstrated encouraging safety and efficacy profile of satri-cel (CT041), a first-in-class CAR T-cell against Claudin18.2. We will continue to drive the global clinical development of satri-cel and look forward to sharing more data updates on satri-cel in the future,” said Raffaele Baffa, MD, PhD, chief medical officer, CARsgen Therapeutics, in a company press release.<\/p>\n

Evaluating the safety of and efficacy of satri-cel in patients with advanced GC\/GEJ or PC who had progressed or were intolerant of prior systemic therapy, the Phase Ib study utilized a modified 3+3 dose escalation\/de-escalation with five dose levels (DLs). DL3 (600\u00d7106 cells) was selected as the recommended phase 2 dose (RP2D), and Phase 2 enrollment is currently underway.1<\/sup><\/p>\n

Over the course of the study, 19 patients were treated across three DLs. The safety profile was encouraging, with no severe adverse events reported.<\/p>\n

In December of 2023, BioSpace reported that FDA placed a clinical hold on three of CARsgen\u2019s CAR T-cell candidates, including CT041, resulting from an inspection of the company\u2019s manufacturing facility in Durham, North Carolina. Facing setbacks in in its CAR-T product advancements, the company expressed commitment to collaborating with FDA to address findings and ensure the progress and quality of clinical trials.2<\/sup><\/p>\n

\u201cThe FDA’s feedback did not pertain to process issues. This provides the company with clear areas of observation, helping us improve in a more targeted manner. We are confident that it will be completed soon and will provide the rectification plan to the FDA as soon as possible, maintain follow-up communication and implement rectifications,\u201d said a company spokesperson in a statement to BioSpace.<\/p>\n

References<\/strong><\/h2>\n
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  1. CARsgen’s Presents Updated Research Results on CT041 at 2024 ASCO GI Meeting. PR Newswire. <\/em>January 19, 2024. Accessed January 19, 2024. https:\/\/www.prnewswire.com\/news-releases\/carsgens-presents-updated-research-results-on-ct041-at-2024-asco-gi-meeting-302038279.html<\/li>\n
  2. FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates. BioSpace. <\/em>December 15, 2023. Accessed January 19, 2024. https:\/\/www.biospace.com\/article\/fda-puts-clinical-hold-on-three-carsgen-therapeutics-car-t-candidates\/<\/li>\n<\/ol>\n