FDA clears IND application for CD20-directed CAR-T to treat B-cell malignancies
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The FDA cleared an investigational new drug application for MB-106, a chimeric antigen receptor T-cell therapy designed to treat patients with relapsed or refractory, CD20-positive B-cell malignancies.
The application includes indications for non-Hodgkin lymphoma and chronic lymphocytic leukemia.
MB-106 (Mustang Bio) is an autologous, gene-edited CAR T-cell therapy that targets the CD20 protein on the surface of cancer cells. The novel agent was based on work done at Fred Hutchinson Cancer Research Center, which is now collaborating with Mustang Bio to develop the cellular therapy.
The IND clearance will allow Mustang Bio to begin enrollment of a multicenter phase 1/phase 2 clinical trial that will evaluate the safety and efficacy of MB-106 for patients with relapsed or refractory CD20-positive B-cell malignancies, including B-cell NHL and CLL. The study is scheduled to start by the end of 2021, according to a press release from the manufacturer.
The FDA based the IND clearance on an interim analysis of an ongoing phase 1/phase 2 study at Fred Hutch that uses the same vector deployed to manufacture MB-106.
Data from the study, presented during last year’s ASH Annual Meeting & Exposition, showed an 89% overall response rate and 44% complete response rate among the first nine patients to receive the therapy for relapsed or refractory B-cell NHL. The therapy also exhibited a favorable safety profile: one patient had grade 3 cytokine release syndrome, but there were no reports of neurotoxicity.
“We are pleased with the FDA’s acceptance of our IND application for MB-106, which allows us to further advance this CAR-T therapy as a potentially safe and effective treatment option for B-NHL and CLL,” Manuel Litchman, MD, president and CEO of Mustang Bio, said in the release. “We are committed to finding better treatment options for patients living with these cancers and look forward to initiating our multicenter, phase 1/phase 2 clinical trial later this year.”
Reference:
Shadman M, et al. Abstract 1443. Presented at: ASH Annual Meeting and Exposition (virtual meeting); Dec. 5-8, 2020.
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