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# FDA Removes Hold on Legend CAR-T Therapy
- URL: https://www.fdaweb.com/fda-removes-hold-on-legend-car-t-therapy/
- Published: 2022-06-01T12:00:00.000Z
- Updated: 2026-09-14T17:46:57.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5151952

FDA has lifted a clinical hold against a Legend Biotech Phase 1 clinical trial of LB1901, an investigational autologous chimeric antigen receptor T-cell (CAR-T) therapy targeting malignant CD4+ T-cells for treating adults with relapsed or refractory T-cell lymphoma*.* The hold was placed in February after one patient had been dosed in the clinical trial and experienced low CD4+ T-cell counts in the peripheral blood. At the time, the company said: “The patient has not experienced drug-related serious adverse events (SAEs) and is being monitored in accordance with the protocol.” The hold removal was announced in a earnings release with no further explanation.