FDA Puts Clinical Hold on Three CARsgen Therapeutics CAR-T Candidates

FDA Entrance_iStock, Grandbrothers

Pictured: FDA headquarters/iStock, Grandbrothers

The FDA has placed a clinical hold on three of CARsgen Therapeutics’ CAR-T cell therapy candidates following an inspection of the Chinese biotech’s manufacturing facility in Durham, North Carolina.

CARsgen notified the Hong Kong Stock Exchange that the FDA clinical hold had gone into effect on three of its CAR-T products: CT053, CT071 and CT041. According to CARsgen, the clinical hold on its products are due to chemistry, manufacturing, and controls-related “questions” that arose due to the FDA inspection.

The company said in the notice that it plans to conduct a “comprehensive review” and improve its Current Good Manufacturing Practices (cGMP) at the facility, which was opened in February 2022.

CARsgen also said in the notice it is “committed to working closely with the FDA to address the findings to ensure the smooth progress and production quality for clinical trials and launching applications.” 

In a statement emailed to BioSpace, a CARsgen spokesperson said that “lingering concerns” surrounding employee training and “other legacy issues” need to be addressed for the facility to be in compliance.

“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,” the spokesperson said.

The FDA’s clinical hold comes at a time when CARsgen was making headway for its CAR-T products.

CARsgen’s CT041 product is a candidate that targets Clauidin18.2 positive solid tumors and is focused on treating gastric, gastroesophageal junction and pancreatic cancer. In August 2023, CARsgen and Moderna announced a partnership to combine an mRNA cancer vaccine with the CT041 CAR-T therapy. Patient enrollment in a Phase II trial for CT041 started in May 2023.

The company’s CT071 targets the G protein-coupled receptor Class C group 5 member D and is placed to treat relapsed/refractory multiple myeloma or relapsed/refractory primary plasma cell leukemia. The product received IND clearance from the FDA in December 2023 and already has an investigator-initiated trial underway in China.

CT053 is designed to treat refractory and relapsed multiple myeloma. Last year, CARsgen presented data from a Phase I/II trial showing that 14 people treated with the candidate had an objective response rate of 100% and a complete response or stringent complete response rate of 78.6%.

CARsgen’s CAR-T cell therapies are not the only ones hit by clinical holds from the FDA. In August 2023, the regulator placed a clinical hold on 2seventy bio’s Phase I trial of its CAR-T therapy for acute myeloid leukemia.

Earlier this month, Roche’s BTK inhibitor fenebrutinib was slapped with a clinical hold after two patients enrolled in a Phase III program for relapsing multiple sclerosis had abnormal elevations in hepatic transaminase levels after receiving the drug.

Tyler Patchen is a staff writer at BioSpace. You can reach him at tyler.patchen@biospace.com. Follow him on LinkedIn.

Back to news