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# Mustang Bio Gets Orphan Status for CAR T Cell Therapy
- URL: https://www.fdaweb.com/mustang-bio-gets-orphan-status-for-car-t-cell-therapy/
- Published: 2022-06-22T12:00:00.000Z
- Updated: 2026-09-14T17:49:34.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5152128

FDA has granted Mustang Bio an orphan drug designation for MB-106, a CD20-targeted, autologous CAR T cell therapy for treating Waldenstrom macroglobulinemia, a rare form of B-cell non-Hodgkin lymphoma (B-NHL). The cell therapy is being developed in a collaboration between Mustang and Fred Hutchinson Cancer Center ("Fred Hutch") to treat patients with relapsed or refractory B-NHL and chronic lymphocytic leukemia (CLL).

The company is planning a Phase 1/2 clinical trial evaluating the safety and efficacy of MB-106 for relapsed or refractory B-NHL and CLL. It says the Phase 1 portion will see MB-106 dose escalation under three separate arms, “and Waldenstrom patients will be included in the indolent lymphoma arm in parallel with accrual of patients to the aggressive lymphoma and CLL arms.”

MB-106 data presented earlier this month at the European Hematology Association 2022 Hybrid Congress showed “high efficacy and a very favorable safety profile across all five dose levels,” Mustang says. “The overall response (ORR) was 96% across all dose levels and all indications (n=26),” it says. “In particular, the 100% complete response rates by PET scan of patients with WM (n=2) as well as of patients with B-NHL previously treated with CD19-directed CAR T cell therapy (n=2) underscore the potential for MB-106 to treat these patient populations with high unmet needs. Durable responses were observed in a wide range of hematologic malignancies including follicular lymphoma, CLL, diffuse large B-cell lymphoma and WM. The possible outpatient administration of this therapy makes it potentially even more compelling.”