OBR OncologyFDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates

Is this latest move from the FDA a reflection on manufacturing standards and their broader impact in oncology?

In a significant development for CAR-T cell therapy, the US Food and Drug Administration (FDA) has placed a clinical hold on three CAR-T cell therapy candidates from CARsgen Therapeutics. This decision follows an inspection of the company’s manufacturing facility in Durham, North Carolina, raising questions related to chemistry, manufacturing, and controls. As CARsgen pledges to address these issues, this situation underscores the critical importance of manufacturing standards in advanced cancer therapies and their potential impact on ongoing clinical trials and future cancer treatments.

Key Points:

1. FDA’s Clinical Hold: The FDA has issued a clinical hold on CARsgen Therapeutics’ three CAR-T cell therapy candidates: CT053, CT071, and CT041, following an inspection of their Durham, North Carolina facility.
2. Reasons for Hold: The clinical hold is primarily due to concerns in chemistry, manufacturing, and controls, as identified during the FDA inspection.
3. Company’s Response: CARsgen plans a comprehensive review and improvement of its Current Good Manufacturing Practices (cGMP) at the facility, opened in February 2022.
4. Commitment to Compliance: CARsgen is dedicated to working with the FDA to rectify the identified issues, focusing on employee training and addressing legacy issues.
5. FDA Feedback: The FDA’s feedback concerns areas of observation rather than process issues, guiding targeted improvements.
6. Impact on Clinical Trials: This hold affects ongoing and planned clinical trials, including a Phase II trial for CT041 and an investigator-initiated trial in China for CT071.
7. CARsgen’s CAR-T Candidates:
   • CT041 targets Claudin18.2 positive solid tumors, intended for gastric, gastroesophageal junction, and pancreatic cancer treatments.
   • CT071 focuses on treating relapsed/refractory multiple myeloma or primary plasma cell leukemia.
   • CT053 is designed for refractory and relapsed multiple myeloma, with a demonstrated high objective response rate in trials.
8. Industry-Wide Precedent: This is not an isolated case, as similar clinical holds were previously issued by the FDA on other companies’ CAR-T therapies and drugs in different trials.

“The 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.” – CARsgen Therapeutics Spokesperson

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