Calidi Biotherapeutics has begun enrolling patients at Northwestern University/Northwestern Memorial Hospital for a clinical trial of CLD-101, an immunotherapy for newly diagnosed high-grade glioma (HGG). The therapy utilizes allogeneic neural stem cells carrying an oncolytic adenovirus, CRAd-S-pk7, and builds upon promising Phase 1 single-dose results published in •The Lancet Oncology•. This Phase 1B/2 trial will investigate multiple doses of CLD-101, led by Drs. Maciej Lesniak and Roger Stupp, and is funded by the NIH/NCI SPORE grant.
This trial represents a critical advancement in the fight against HGG, an aggressive brain cancer with limited treatment options. The shift to a multi-dose regimen in newly diagnosed patients could significantly improve efficacy compared to a single dose. This is especially crucial given the aggressive nature of the disease, offering the potential for earlier and more potent intervention. The involvement of renowned experts like Dr. Stupp, known for developing the Stupp Protocol for glioblastoma, lends considerable weight and expertise to the study.
The trial builds on previous single-dose data published in a top-tier journal. The NIH/NCI SPORE grant funding underscores the scientific community’s recognition of the therapy’s potential. This new trial is designed to evaluate the safety and efficacy of multiple doses, a key step towards establishing a more effective treatment protocol.
The results of this trial hold significant implications for the future of HGG treatment. Positive data could pave the way for a new standard of care, offering hope for improved survival and quality of life for patients diagnosed with this devastating cancer. It also further validates Calidi’s platform technology, strengthening its potential to develop treatments for other solid tumors and metastatic cancers.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
