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# Bellicum Studies on FDA Clinical Hold
- URL: https://www.fdaweb.com/bellicum-studies-on-fda-clinical-hold/
- Published: 2018-01-31T12:00:00.000Z
- Updated: 2026-09-14T23:18:47.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5140641

FDA has placed a clinical hold on Bellicum Pharmaceuticals’ U.S. studies of its BPX-501 after reports of three cases of encephalopathy possibly related to the drug. The company says it is awaiting formal FDA communication on the requirements for resuming studies, and will work closely with the agency to address its questions.

Bellicum [says](https://globenewswire.com/news-release/2018/01/30/1314666/0/en/Bellicum-Pharmaceuticals-Announces-Clinical-Hold-on-BPX-501-Clinical-Trials-in-the-United-States.html?ref=fdaweb.com) it has “treated more than 240 patients with BPX-501 cells on three allogenic haploidentical stem call transplant protocols. These three cases are complex, with a number of potential confounding factors including, in certain of the cases, prior failed transplants, prior history of immunodeficiency, concurrent infection, and administration of rimiducid in combination with other medications. Bellicum is working with FDA to evaluate the risk of encephalopathy in patients receiving BPX-501.”