Bispecific CAR-T induces response in blood cancers
Click Here to Manage Email Alerts
Three-quarters of patients with advanced B-cell malignancies who received an investigational chimeric antigen receptor T-cell therapy achieved complete response, according to the agent’s manufacturer.
MB-106 (Mustang Bio) is an autologous, gene-edited CAR T-cell therapy that targets the CD20 protein on the surface of cancer cells.
Fred Hutchinson Cancer Research Center and Mustang Bio are collaborating to develop the cellular therapy for treatment of relapsed or refractory B-cell malignancies, including non-Hodgkin lymphomas and chronic lymphocytic leukemia.
The phase 1/phase 2 trial included 28 patients with hematologic malignancies, including follicular lymphoma, chronic lymphocytic leukemia and diffuse large B-cell lymphoma.
Interim analysis results showed a 96% overall response rate for the entire study population, with 75% achieving complete responses to therapy.
Twelve patients experienced complete responses that lasted longer than 12 months, and 10 of those patients remained in response at the data cutoff date.
Four patients remained in complete response for more than 2 years, with one patient maintaining a complete response at 33 months after infusion.
Two patients with Waldenstrom macroglobulinemia — a rare type of non-Hodgkin lymphoma — experienced complete response after a single dose of the therapy.
All three patients who underwent prior CD19-directed CAR T-cell therapy responded to treatment.
Researchers reported no cases of grade 3 or higher cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome.
The FDA previously granted the investigational agent orphan drug designation for treatment of Waldenstrom macroglobulinemia.
“We are very pleased with the advancement of the MB-106 clinical program,” Manuel Litchman, MD, president and CEO of Mustang Bio, said in a company-issued press release.
“Additionally, we are grateful that the Fred Hutch team continues to present compelling data from its ongoing phase 1/2 clinical trial that demonstrate high efficacy and a favorable safety profile,” Litchman added. “Having been granted orphan drug designation by the FDA for [Waldenstrom macroglobulinemia], we are looking forward to treating additional patients in the Mustang-sponsored phase 1 portion of our trial to support a fast-to-market phase 2 strategy for this indication.”
Click Here to Manage Email Alerts