Mustang Bio, a biopharmaceutical company, and City of Hope, a cancer center, have just revealed that their first participant in their Phase 1 clinical trial for leptomeningeal brain tumors including glioblastoma, medulloblastoma, and ependymoma. This trial is evaluating the safety and the efficacy of MB-101.
Previous research has demonstrated the potential of this therapy, specifically when infused in the ventricular system. It has actually been shown to lead to complete response for leptomeningeal glioblastoma patients.
This study will include a maximum of 30 participants and will be located at the City of Hope facility, where the therapy was first developed.
However, both organizations will be facilitating patient travel as needed.
MB-101 is a CAR T therapy or, a chimeric antigen receptor T cell therapy. This specific therapy targets ILL13Ra2. This is expressed minimally in normal tissue however, it is overexpressed on most malignant glioma cells.
In this study the therapy will be administered using an ICV Rickham catheter. Each participant will have surgery to place the ICV. Then, over a 4 week period, the treatment will be administered.
Arm one of the trials includes glioblastoma patients and arm two of the trial includes medulloblastoma and ependymoma patients. The primary endpoints of both arms are toxicity of the therapy and survival at the 3 month mark. The secondary endpoints are overall survival, cytokine levels, T cell levels, CAR T cell levels, as well as phenotype detection in tumor cyst fluid, cerebrospinal fluid, and peripheral blood.
You can read more about this trial on Clinicaltrials.gov or here.