> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA Lifts Hold on Hemogenyx CAR-T Therapy
- URL: https://www.fdaweb.com/fda-lifts-hold-on-hemogenyx-car-t-therapy/
- Published: 2024-02-12T12:00:00.000Z
- Updated: 2026-09-14T14:22:40.000Z
- Author: David McFarland
- Tags: Biologics, #legacy-id-D5156340

FDA has lifted a clinical hold against Hemogenyx Pharmaceuticals’ IND for the company’s chimeric antigen receptor T-cells (CAR-T) therapy for treating acute myeloid leukemia. The hold was issued 7/2023 and was related to a “splicing that occurs during the manufacturing process of the lentivirus that is used to produce CAR-T cells,” the company said at the time. It said it had identified the source of the splicing deficiency and had already developed a method to eliminate it, requiring the lentivirus to be remanufactured. Hemogenyx now says it is proceeding with its Phase 1 clinical study of Hemo-CAR-T.