FDA lift clinical hold placed on the phase 1 PSMA-101-001 study of the chimeric antigen receptor T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer.
The FDA has lifted the clinical hold placed on the phase 1 PSMA-101-001 study (NCT04249947) of the CAR T-cell therapy P-PSMA-101 in patients with metastatic castration-resistant prostate cancer (mCRPC), according to Poseida Therapeutics, Inc, the drug developer.1 The company announced plans to resume the trial immediately, noting that they have agreed to make amendments to the protocol in an effort to increase patient compliance and safety. Some of these modifications are with regard to study inclusion and exclusion criteria, as well as frequency of monitoring and laboratory testing.
In August 2020, the regulatory agency made the decision to place a clinical hold on the trial examining P-PSMA-101 after a notification of a patient death had been issued by the company.2 The patient, who had reportedly progressed on many anticancer agents prior to receiving the CAR T-cell therapy in late July 2020, had normal laboratory results after the first week of treatment; the patient did not showcase any clinical symptoms suggestive of an adverse effect, according to the company.
Despite this, the patient missed his follow-up visits that were scheduled for day 10 and day 14 following treatment with the product. During that time span, he reportedly presented with symptoms that resulted in hospitalization. On day 19, the patient experienced hepatic failure and died. At the time of the report, the cause of the hepatic failure had not been confirmed, although the patient experienced symptoms that proved to be consistent with macrophage activation syndrome (MAS). It is known, however, that MAS can be caused by other events beyond treatment with CAR T-cell therapy, such as autoimmune disease or infection.