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The plan to launch the phase 1 trial to evaluate the safety and efficacy of combining the CAR-T cell therapy and oncolytic virus in patients with recurrent glioblastoma, a type of brain cancer, is supported by interim data from two ongoing trials.
Mustang Bio announced that it plans to launch a phase 1 clinical trial to assess the safety and efficacy of combining MB-108, an investigational oncolytic virus, with the CAR-T cell therapy MB-101 in a group of patients with recurrent glioblastoma, which is a type of brain cancer.
The decision comes after the early findings of two studies were presented at the recent American Association for Cancer Research (AACR) Annual Meeting.
“The data presented at the AACR Annual Meeting support the initiation of a phase 1 clinical trial to evaluate combining locoregional delivery of MB-108 and MB-101 as an attractive strategy for improving outcomes for patients with (recurrent glioblastoma). We are excited to build on the interim clinical safety and feasibility data for administering either single agent MB-101 or MB-108, as well as to take advantage of the potential of oncolytic viral therapy to make the tumor immunologically ‘hot’ since clinical data suggest that CAR T cells may be more effective in an inflamed tumor microenvironment,” Christine Brown, the deputy director of the T-Cell Therapeutics Research Laboratory at City of Hope Comprehensive Cancer Center in Duarte, California, said in a press release.
One of the trials Mustang Bio is referencing analyzed the feasibility and safety of the repeated delivery of the CAR-T cell therapy among 65 patients with recurrent or refractory malignant glioma who had previously received multiple lines of therapy. The results, according to the release, demonstrated that the weekly administration of treatment directly into the tumor, as well as into the central nervous system (to bypass the blood brain barrier) or both, appeared to be safe with manageable side effects. Moreover, the release continued, a final cohort of 19 patients showed that treatment may result in a survival benefit when compared with historical controls.
The other trial, which is ongoing at the University of Alabama at Birmingham, showed that a single infusion of the oncolytic virus into a patient with recurrent glioblastoma led to the death of cancer cells seven weeks post treatment.
“Recurrent (glioblastoma) remains a major challenge to treat with a median overall survival rate of six months,” Dr. Manuel Litchman, president and CEO of Mustang Bio, said in the release. “The MB-101 and MB-108 programs continue to enroll patients in Phase 1 clinical trials at City of Hope and UAB, respectively. Given the preclinical study outcomes, future efforts will include the combination therapy MB-109, for which we plan to file an investigational new drug application later this year.”
Of note, an investigational new drug application is a request from a trial sponsor to get authorization from the Food and Drug Administration to begin treating humans with an investigation drug.
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