Home Cancer Site Watch: CARTI First to Enroll Patients in Imaging Clinical Trial

Site Watch: CARTI First to Enroll Patients in Imaging Clinical Trial

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CARTI Cancer Center (CARTI) has been fighting cancer for over four decades with several treatment centers near Arkansas, U.S. It’s mission is to promote the finest quality cancer treatment and compassionate care—they are dedicated to fighting cancer with up-to-date knowledge, education and research. Organized as an independent, not-for-profit cancer care provider, CARTI offers state of the art cancer treatment for more than 22,000 patients annually throughout Arkansas.

Most recently, The Cabin reported the first three patients were enrolled in a Phase II clinical trial sponsored by ImaginAB’s CD8+ T cell imaging agent. CARTI is the first site in the nation to have open trials currently enrolling patients. Enrolling patients in clinical research is often difficult. This demonstrates CARTI’s ability to conduct advanced clinical research.

“ImaginAB is an immune and oncology imaging company developing a pipeline of novel products that give physicians unprecedented insights into the patient’s health—enabling better patient selection and treatment monitoring for immune-oncology therapies and other drugs.” (http://www.imaginab.com/) Based in Los Angeles, California, ImaginAB has raised $46.8 million since their founding in 2007.

Sponsor ImaginAb seeks to enroll metastatic cancer patients in their study to to further correlate imaging signals observed using ImaginAb’s CD8+ T cell ImmunoPET imaging agent, standard-of-care scans, and immunohistochemistry analysis of CD8 in biopsied tissues. The sponsor seeks to use the trial to measure changes in CD8+ T cell distribution before and after immune-oncology therapies.

Phase I of the ImaginAB study went well—demonstrating an excellent safety profile and encouraging preliminary efficacy of the CD8+ T cell Immuno-PET imaging tracer according to Ian Wilson, COO of ImaginAB.

The actual study is a Phase II, Open Label, Multi-Dose Study of Positron Emission Tomography (PET/CT) with ⁸⁹Zr-Df-IAB22M2C (CD8 Tracer) in Patients with Metastatic Solid Tumors. This study will evaluate the safety of repeat doses of ⁸⁹Zr-Df-IAB22M2C, assess and quantify any detectable changes in ⁸⁹Zr-Df-IAB22M2C uptake from Baseline to post-Treatment, establish the relationship of ⁸⁹Zr-Df-IAB22M2C uptake in tumors with CD8+ TIL density, biodistribution. It will evaluate the variance in participants’ gene expression pre- and post-Treatment, evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with clinical response by RECIST 1.1/iRECIST and evaluate the correlation of ⁸⁹Zr-Df-IAB22M2C uptake with immune infiltrates and other molecular biomarkers (CD4, CD8, PD-1 and PD-L1) expression by IHC.

Lead Research/Investigator
David Hays, MD

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