CAR T-Cell Therapy Yields High Response Rates in Follicular Lymphoma

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.”

REFERENCES

1. Shadman M, Yeung C, Redman M, et al. Efficacy and safety of a third generation CD20 CART (MB-106) for treatment of relapsed/refractory follicular lymphoma (FL). Presented at: EHA 2022 Congress, June 9-12, Vienna, Austria and virtually. Abstract #S207.
2. Mustang Bio announces updated interim results from Follicular Lymphoma cohort of ongoing phase 1/2 clinical trial of MB-106, CD20-targeted CAR T therapy. News release. Mustang Bio. June 13, 2022. https://www.globenewswire.com/news-release/2022/06/13/2461188/0/en/Mustang-Bio-Announces-Updated-Interim-Results-from-Follicular-Lymphoma-Cohort-of-Ongoing-Phase-1-2-Clinical-Trial-of-MB-106-CD20-Targeted-CAR-T-Therapy.html