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Mustang Bio Doses First Patient in CD20-Directed CAR T-Cell Therapy Trial

NEW YORK – Mustang Bio said on Thursday that the first patient has received MB-106 in a Phase I/II study exploring the cell therapy's activity in advanced lymphoma and leukemia.

The trial is designed to evaluate the safety and preliminary efficacy of the firm's autologous, CD20-directed CAR T-cell therapy as a treatment for patients with relapsed or refractory non-Hodgkin lymphoma (NHL) or chronic lymphocytic leukemia (CLL).

According to Worcester, Massachusetts-based Mustang, the first patient treated in this trial did not experience cytokine release syndrome or immune effector cell-associated neurotoxicity syndrome, both of which can be concerns with autologous cell therapies.

In addition to this Phase I/II study, other trials of MB-106 are also underway. Academic researchers at the Fred Hutchinson Cancer Research Center are evaluating the treatment in an investigator-sponsored trial involving 28 patients with various cancers including follicular lymphoma, CLL, diffuse large B-cell lymphoma (DLBCL), and Waldenstrom macroglobulinemia. As of last month, the researchers reported an overall response rate of 96 percent on MB-106 and a complete response rate of 75 percent, with 12 patients experiencing a complete response for more than one year. Three patients on that trial who previously received anti-CD19 CAR T-cell therapy have responded to MB-106.

The latest trial from Mustang will take place at six cancer centers and enroll 287 patients with CLL and B-NHL, including those with follicular lymphoma, DLBCL, and mantle cell lymphoma. To be eligible for the trial, patients' cancers must express CD20.

In the Phase I portion of the trial, Mustang expects to treat up to 18 patients in each of the three arms. In the Phase II portion, the firm will treat 20 patients in each arm to start and, contingent on interim results, expand to add 71 patients in each arm. In the study, the company hopes to establish MB-106's safety, tolerability, recommended Phase II dose, and preliminary efficacy.

According to Mustang, its Phase I/II trial is using the same lentiviral vectors as Fred Hutch to engineer the autologous CAR T-cell therapy. The experience with the drug in the Fred Hutch study led the US Food and Drug Administration to allow Mustang to begin treating patients at a higher MB-106 dose than was allowed originally in the Fred Hutch trial.

Mustang expects to share updates on the trial, including efficacy data, during the fourth quarter of this year.