Brain cancer stem cell trial begins recruitment: Calidi Biotherapeutics ships first batch to Northwestern University for the trial

Calidi Biotherapeutics Inc. announced that Northwestern University and Northwestern Memorial Hospital have begun patient trial recruitment for Calidi’s immunotherapy candidate, CLD-101.

CLD-101 consists of allogeneic neural stem cells loaded with the oncolytic adenovirus CRAd-S-pk7 (a virus engineered to selectively infect and destroy cancer cells). The company is investigating whether this candidate will support patients with newly diagnosed high-grade glioma, an aggressive and often fatal type of brain cancer.

The clinical trial is physician-led and sponsored by the National Cancer Institute (NCI). It will be overseen by Dr. Maciej Lesniak and Dr. Roger Stupp. The trial builds on results from a previous Phase 1 study published in The Lancet Oncology, in which 12 patients received a single dose of CLD-101. The current Phase 1B/2 trial introduces a regimen of multiple doses of CLD-101 for newly diagnosed patients, with the goal of improving treatment effectiveness and patient outcomes.

“I am extremely excited about the commencement of recruitment for the multiple dose CLD-101 trial in newly diagnosed HGG patients. This increases the probability of success due to the improved treatment regimen initiated as early as possible in this devastating disease,” said Dr. Lesniak, chairman of the Department of Neurological Surgery at Northwestern University’s Feinberg School of Medicine.

The trial has been granted funding by the NIH/NCI SPORE to support this pioneering study.

Both Dr. Lesniak and Dr. Stupp have extensive experience in treating brain tumors. Dr. Stupp is known internationally for developing the FDA-approved “Stupp Protocol,” a treatment regimen that has significantly impacted the standard of care in glioblastoma.

“We are proud to have assembled a world-class team of surgeons and neuro-oncologists to lead this trial,” said Allan Camaisa, Chief Executive Officer and Chairman at Calidi Biotherapeutics. “Should the results of this trial demonstrate treatment outcomes consistent with the previous study, now in a larger patient group and with multiple doses of CLD-101, the implications could be transformative for the treatment of brain tumors. Together with our systemic, enveloped virus platform, I believe we are developing a portfolio of products to address glioblastoma, solid tumors and metastatic cancer.”