Maria Pia Morelli, MD, PhD, on Promising Safety of Sleeping Beauty TCR-T Therapy in Solid Tumors


The assistant professor at MD Anderson Cancer Center discussed progress of the phase 1/2 trial being conducted at the center.

“The study has been definitely safe, shows some promising activity, and we've been able to, so far, manufacturing adequate products to treat our patients... The trial is still ongoing. We have another dose level that we want to go up to. The trial is still enrolling, we are actively screening patients, and will be treating more in the coming weeks.”

Updated data from a phase 1/2 trial (NCT05194735) of sleeping Beauty T-cell receptor T-cell (TCR-T) therapy (Alaunos Therapeutics) being conducted at The University of Texas MD Anderson Cancer Center, Houston, TX, has shown promising signs of efficacy with a manageable safety profile in patients with mutant KRAS, EGFR and TP53-expressing solid tumors, including non-small cell lung (NSCLC), colorectal, endometrial, pancreatic, ovarian and bile duct cancers.

The new data, from the first 3 patients treated, were presented by investigator Maria Pia Morelli, MD, PhD, assistant professor, department of gastrointestinal (GI) medical oncology, division of cancer medicine, MD Anderson, at the 2023 American Society of Clinical Oncology (ASCO) meeting, held June 2-6, 2023, held both virtually and in Chicago, Illinois.

CGTLive™ spoke with Morelli to learn more about the data she presented and the progress of the trial. She encouraged clinicians with patients that may be eligible for the trial to refer them to trial centers nearby without delay, as manufacturing cell therapies still takes weeks.

Click here for more coverage of ASCO 2023.

Morelli MP, Negrao MV, Collinson-Pautz MR, et al. Safety and efficacy of Sleeping Beauty TCR-T cells targeting shared KRAS and TP53 mutations expressed by solid tumors in first-in-human phase 1 study. Presented at: 2023 ASCO Meeting; June 2-6; Chicago, Illinois. Poster #389
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