Progress Reported in Phase 1 Trial of CLD-101 for Recurrent Glioma

Among patients with recurrent high-grade glioma, treatment with the investigational agent CLD-101, neural stem cell-based oncolytic virotherapy, showed safety and feasibility, according to a progress report of the phase 1 trial which was shared in a news release from the drug’s manufacturer, Calidi Biotherapeutics.

“We are optimistic about the initial results in these first 14 patients. I am especially encouraged by cohort 4 as we keep enrolling participants in this highest treatment schedule,” said Dr. Jana Portnow, co-director of the Brain Tumor Program at City of Hope, in Duarte, California, and the trial’s principal investigator.

This phase 1 trial is evaluating the safety and feasibility of delivering up to four weekly intracerebral doses of CLD-101. So far, 14 participants have been treated, and all participants have tolerated the treatment well, according to the release. The study is now enrolling participants at the highest treatment schedule.

Dr. Karen Aboody, a professor in the Department of Stem Cell Biology and Regenerative Medicine at City of Hope, and Portnow have played a key role in developing this approach, as per the release.

During the trial, patients will undergo standard of care surgical resection before receiving CLD-101 intracerebrally over 10 minutes once a week for up to four doses, unless the patient’s disease progresses, or unacceptable toxicity occurs. After completing treatment, patients will be monitored at three and six months, then annually.

The trial will aim to determine the maximum tolerated number of cycles of intracavitary-administered CLD-101 for phase 2 testing based on dose-limiting toxicities, overall toxicity profile and activity in patients with recurrent high-grade glioma.

City of Hope Medical Center and Wake Forest University in Winston-Salem, North Carolina, are among the available sites. This clinical trial is now also open at Northwestern University Feinberg School of Medicine and Stanford University Hospitals.

Additional Information on CLD-101 Treatment

Gliomas are tumors that develop in glial cells, which support and protect nerve cells in the brain and spinal cord. These tumors can be benign or malignant and can form anywhere in the brain or spinal cord. Gliomas are classified as low grade or high grade based on the appearance of the tumor cells and their potential for growth, spread, and recurrence. The three main types are astrocytomas, oligodendrogliomas and ependymomas. Gliomas can affect both adults and children and are also known as glial tumors. To address the unmet needs present in this population, investigators are evaluating CLD-101.

Previously, the Food and Drug Administration cleared an investigational new drug application for CLD-101. Previous trials demonstrated CLD-101's safety and potential efficacy, with patients showing a median progression-free survival of 9.05 months and a median overall survival of 18.4 months.

CLD-101 is composed of neural stem cells carrying a virus that targets and kills cancer cells. Administering multiple doses may lead to greater tumor cell destruction, according to the trial investigators.

Oncolytic virus treatment uses a virus that infects and destroys cancer cells without harming normal cells, according to the National Cancer Institute’s website. This therapy may enhance the effectiveness of chemotherapy and radiation. It is a form of targeted therapy, also known as oncolytic virus therapy, viral therapy, or virotherapy.

“We are dedicated to improving clinical outcomes of cancer patients with the use of stem cell technology to deliver oncolytic virus payloads to cancer sites,” said Allan Camaisa, chief executive office and chairman of Calidi, in the news release. “Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer.”

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