New switchable CAR-T therapy enters phase 1 trial for advanced breast cancer

The Calibr-Skaggs Institute for Innovative Medicines, the drug development division of Scripps Research, today announced a milestone in cancer treatment with the dosing of the first patient in a phase 1 trial (NCT06878248) evaluating CLBR001 + ABBV-461, a modular, switchable chimeric antigen receptor T cell (sCAR-T) therapy in patients with advanced or metastatic breast cancer who have no suitable treatment options. This is the first study of the sCAR-T platform in solid tumors.

CAR-T therapy has been transformative for patients with hematological malignancies who failed numerous prior treatments. However, conventional CAR-T therapies have not yet been as successful at treating patients with solid tumors. This challenge is what Calibr-Skaggs' switchable CAR-T cell therapy platform was designed to address.

The sCAR-T platform developed by Calibr-Skaggs is designed to enhance the precision and safety of CAR-T therapies, and has demonstrated promising preliminary results in a phase 1 clinical trial for hematological malignancies. Additionally, initial results have demonstrated CLBR001 sCAR-T cells can expand in the body in significantly greater numbers than conventional CAR-T cells, affording a better chance of penetrating the hostile solid tumor microenvironment. And the switch offers an added advantage by allowing the cells to "rest," potentially avoiding CAR-T exhaustion.

There's a critical need to develop gene and cell therapy approaches that are able to recreate the success observed in blood cancers for patients with solid tumors like breast cancer. By integrating an antibody-based 'switch,' there's the potential to enhance the precision of targeting solid tumor cells, while also mitigating potential safety risks."

Travis Young, PhD, vice president of biology at Calibr-Skaggs

The clinical trial testing CLBR001 + ABBV-461 is now underway in the US. CLBR001 + ABBV-461 is being developed in collaboration with AbbVie.

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