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# Hemogenyx CAR-T Therapy on Clinical Hold
- URL: https://www.fdaweb.com/hemogenyx-car-t-therapy-on-clinical-hold/
- Published: 2023-07-10T12:00:00.000Z
- Updated: 2026-09-14T18:42:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5154840

FDA has issued Hemogenyx Pharmaceuticals a clinical hold on an IND for the company’s chimeric antigen receptor T-cells (CAR-T) therapy for treating acute myeloid leukemia. The company says the hold is related to a “splicing that occurs during the manufacturing process of the lentivirus that is used to produce CAR-T cells.” It says it has identified the source of the splicing deficiency and has already developed a method to eliminate it, and the lentivirus is being remanufactured. FDA’s clinical hold letter also contains several suggestions to improve the safety of the CAR-T therapy, Hemogenyx says.