NEXI-002

P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Dec 2023 --> Dec 2025 | Trial primary completion date: Nov 2023 --> Nov 2024

P1/2, N=9, Suspended, NexImmune Inc. | Trial completion date: Nov 2022 --> Dec 2023 | Terminated --> Suspended | Trial primary completion date: Aug 2022 --> Nov 2023

P1/2, N=9, Terminated, NexImmune Inc. | N=22 --> 9 | Recruiting --> Terminated; Lack of accrual

Bridging anti-MM treatment was permitted during the manufacture of the cellular product with a wash-out period of at least 14 days prior to lymphodepletion (LD) chemotherapy (intravenous fludarabine 30 mg/m 2 and cyclophosphamide 300 mg/m 2 ), which was administered on Days -5, -4, and -3 prior to the infusion of the NEXI-002 product up to 72 hours later (Day1). RNA Seq transcriptional profiling of the CD8+ T cells is planned. Additional patients have recently received NEXI-002 infusions and the trial will continue to be expanded to gain additional safety, immunologic, and clinical activity experience.

Results Three patients were treated with single infusions of 80 to 100 million cells of NEXI-002 following lymphodepleting chemotherapy (fludarabine 30 mg/m2 and cyclophosphamide 300 mg/m2 on Days -5 to -3). Due to these encouraging findings, the trial will be expanded to gain greater safety and activity experience with NEXI-002. Updated data will be available.