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FDA places clinical hold on trial of CAR-T for metastatic pancreatic, prostate cancer

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December 08, 2020

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The FDA placed a clinical hold on a phase 1/phase 2 trial designed to evaluate BPX-601 — a chimeric antigen receptor T-cell therapy — followed by rimiducid for patients with previously treated metastatic pancreatic or prostate cancer.

The agency placed the trial on hold after the manufacturer reported the death of one participant with pancreatic cancer.

Sign outside FDA HQ in Washington, DC.
Source: Adobe Stock.

The study investigator determined the death to be unrelated to BPX-601 (Bellicum Pharmaceuticals) and rimiducid, according to a press release from the manufacturer.

BPX-601 is an autologous CAR T-cell therapy that targets tumor cells expressing high levels of prostate stem cell antigen (PSCA). The investigational therapy uses Bellicum’s proprietary dual-switch GoCAR-T, which allows clinicians to either activate or eliminate the CAR T cells with the administration of small molecules to enhance real-time control of the agent.

The clinical hold means Bellicum must halt patient enrollment and dosing in the ongoing dose-escalation trial.

“The company plans to work diligently with the FDA to address the agency’s questions and fulfill the requirements for resuming the trial,” the press release stated.

The hold will not delay initiation of enrollment by year’s end in a phase 1/phase 2 trial of BPX-603, a dual-switch CAR T-cell therapy Bellicum is developing for patients with HER2-postive solid tumors, according to the press release.

https://www.healio.com/news/hematology-oncology/20201208/fda-places-clinical-hold-on-trial-of-cart-for-metastatic-pancreatic-prostate-cancer

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