CAR-M/Pembrolizumab Trial Doses First Patient With HER2-Overexpressing Solid Tumors
Initial data from the combination substudy are expected in the second half of 2023.
Carisma Therapeutics has dosed the first patient with HER2-overexpressing
"We are excited by the progress being made on our CT-0508 clinical program with the dosing of the first patient in the combination study with KEYTRUDA®," Michael Klichinsky, PharmD, PhD, cofounder and chief scientific officer, Carisma Therapeutics, said in a statement.1 "The CT-0508 monotherapy trial has demonstrated early clinical validation of the CAR-M mechanism of action, and we are eager to explore this sub-study to assess the potential synergistic effect of CAR-M therapy in combination with KEYTRUDA®. The initiation of clinical manufacturing at Novartis' GMP cell therapy site is also a meaningful step forward in progressing our overarching manufacturing strategy, and demonstrates our desire to work alongside best-in-class companies."
The trial has been initiated at multiple site locations in the United States. It is a substudy of an ongoing, first-in-human trial evaluating the safety of CT-0508 alone in patients with solid tumors. Initial data from the substudyare expected in the second half of 2023.2
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The most updated data from the parent trial were presented at the
“The data from Group 1 of our first-in-human CAR-M clinical trial provides evidence that CAR-M therapy is feasible and generally well-tolerated by patients with certain late-stage metastatic cancers,” Klichinsky, said in an earlier statement.4 “The translational data collected from these patients is highly encouraging. We look forward to advancing CT-0508 into Group 2 of the monotherapy safety trial, as well as in a combination sub-study with the T cell checkpoint inhibitor pembrolizumab.”
REFERENCES
1. Carisma Therapeutics announces first patient dosed in phase 1 study of CT-0508 in combination with KEYTRUDA® (pembrolizumab) in patients with HER2 overexpressing solid tumors. News release. June 28, 2023. https://www.prnewswire.com/news-releases/carisma-therapeutics-announces-first-patient-dosed-in-phase-1-study-of-ct-0508-in-combination-with-keytruda-pembrolizumab-in-patients-with-her2-overexpressing-solid-tumors-301865175.html
2. Carisma Therapeutics reports second quarter 2023 financial results and recent business highlights. News release. Carisma Therapeutics. August 10, 2023. https://ir.carismatx.com/news-releases/news-release-details/carisma-therapeutics-reports-second-quarter-2023-financial
3. Reiss KA, Yuan Y, Ueno NT, et al. A phase 1, first-in-human (FIH) clinical trial of the anti-HER2 CAR macrophage CT-0508 in participants with HER2 overexpressing solid tumors. Presented at: SITC 37th Annual Meeting, November 8012, 2022, in Boston, Massachusetts. Poster #634
4. Carisma Therapeutics announces clinical & pre-clinical updates. News release. Carisma Therapeutics. November 11, 2022. https://carismatx.com/carisma-therapeutics-announces-clinical-pre-clinical-updates/
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