The FDA placed a clinical hold on patient enrollment and dosing for the ongoing phase 1/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer.
The FDA has placed a clinical hold on patient enrollment and dosing for an ongoing phase 1/2 dose-escalation clinical trial evaluating BPX-601 in patients with previously treated metastatic pancreatic or prostate cancer, according to Bellicum Pharmaceuticals, the developer of the agent.
The FDA indicated it is taking this action due to the death of a patient with pancreatic cancer in the trial reported to the agency by the company. However, the clinical investigator and Bellicum reported that the patient death was unrelated to BPX-601 and rimiducid.
Bellicum suggested it intends to work closely with the FDA to address the agency’s questions and fulfill the requirements for resuming the trial.
BPX-601, the company’s first GoCAR-T product candidate, incorporates iMC (inducible MyD88/CD40). iMC is designed to provide a powerful boost to T cell proliferation and persistence, production of immunomodulatory cytokines, and enable the CAR-T to override key immune inhibitory mechanisms, including PD-1 and TGF-beta. BPX-601 is being evaluated as a treatment for both pancreatic and prostate tumors expressing prostate stem cell antigen.
Importantly, the clinical hold does not affect Bellicum’s plans to initiate enrollment in the phase 1/2 clinical trial of BPX-603, a dual switch GoCAR-T, in patients with HER2-positive solid tumors by the end of the year.
Bellicum Reports Clinical Hold Placed on BPX-601 Phase 1/2 Clinical Trial [news release]. Houston. Published December 7, 2020. Accessed December 7, 2020. https://www.globenewswire.com/news-release/2020/12/07/2140457/0/en/Bellicum-Reports-Clinical-Hold-Placed-on-BPX-601-Phase-1-2-Clinical-Trial.html