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# FDA Lifts Hold on Leukemia/Lymphoma Therapy
- URL: https://www.fdaweb.com/fda-lifts-hold-on-leukemia-lymphoma-therapy/
- Published: 2022-12-02T12:00:00.000Z
- Updated: 2026-09-14T18:08:19.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5153313

FDA has lifted a clinical hold against Beam Therapeutics and its BEAM-201 for treating relapsed/refractory T-cell acute lymphoblastic leukemia/T-cell lymphoblastic lymphoma. The company [says](https://www.fdaweb.com/beam-hit-with-clinical-hold-on-car-t-therapy/) it filed the IND at the end of June for the specific anti-CD7, multiplex-edited, allogeneic chimeric antigen receptor T cell (CAR-T) development candidate, and the agency placed the hold late July.

In a recent SEC [filing](https://www.sec.gov/ix?doc=/Archives/edgar/data/1745999/000095017022017868/beam-20220825.htm&ref=fdaweb.com), Beam said the agency’s official clinical hold letter requested **(1)** additional control data from genomic rearrangement assessments; **(2)** further analyses of certain off-target editing experiments; **(3)** additional control data for a cytokine independent growth assay; and **(4)** an updated investigator brochure that includes information regarding any new nonclinical studies.