Mustang Bio presented data on MB-106 at the 2022 EHA Congress.
Mustang Bio’s CD20-targeted chimeric antigen receptor (CAR) T-cell therapy MB-106 has shown efficacy in the follicular lymphoma (FL) cohort of a phase 1/2 trial (NCT03277729).1
Findings from the trial were presented at the European Hematology Association (EHA) 2022 Congress, June 9-12, held both virtually and in Vienna, Austria, byMayzar Shadman, MD, MPH, associate professor, clinical research division, Fred Hutchinson Cancer Center, where the trial was conducted.
“We continue to observe a favorable safety profile and high rate of complete response with MB-106 as exhibited by this follicular lymphoma cohort and within a wide range of other hematologic malignancies including CLL, diffuse large B-cell lymphoma (DLBCL) and Waldenstrom macroglobulinemia (WM),” Shadman said in a statement.2 “Based on the ongoing progress, MB-106 may be a suitable outpatient treatment for these patients and another immunotherapy option for patients for whom CD19-directed CAR T cell therapy is not effective. Enrollment in this study remains open to patients with CD20+ B-NHLs and CLL, including patients with prior CAR T treatment.”
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Eighteen patients with FL have been infused with 1x105, 3.3x105, 1x106, 3.3x106 or 1x107 CAR T cells/kg.1 All patients, except for the firstof each dose cohort which were kept for overnight observation, were infused in the outpatient setting. Overall response rate (ORR) was 94% (n = 17) and complete response (CR) rate was 78% (n = 14). Three patients (17%) had a partial response and 1 (5%) experienced disease progression.
One patient experienced pseudo-progression followed by a spontaneous, continuing CR. Another patient had prior CD19 CAR T therapy failure and has also had a continuing CR. Patients with other B-cell non-Hodgkin lymphomas (B-NHLs) including DLBCL and WM had a 100% ORR.
Five patients experienced cytokine release syndrome (CRS), 4 had grade 1 and 1 had grade 2 CRS. No patients with FL experienced immune effector cell associated neurotoxicity syndrome. CAR T-cell expansion was fastest at the highest dose levels although persistence was comparable by day 28.
An additional multicenter trial (NCT05360238) has also opened enrollment to assess MB-106 for relapsed or refractory B-cell non-Hodgkin lymphoma (NHL) and chronic lymphocytic leukemia (CLL) under Mustang Bio’s investigational new drug application.
“Given the ongoing positive progress presented by Dr. Shadman, we look forward to evaluating MB-106 to treat relapsed or refractory B-NHL and CLL in the multicenter clinical trial under Mustang’s IND which is now open to enrollment. MB-106 continues to demonstrate its potential as a safe, effective CAR T therapy that can address the unmet needs of a range of patients with relapsed or refractory B-NHLs, including WM and DLBCL, with outpatient administration,” Manuel Litchman, MD, president and chief executive officer, Mustang Bio, added to the statement.2 “It is especially gratifying to see that the DLBCL patient previously reported as a PR has now improved to a CR, which therefore represents a second CR in DLBCL and a second CR in a patient previously treated with CD19-targeted CAR T therapy.”