The FDA cleared the University of Texas MD Anderson Cancer Center to start a phase I study of JV-394, a CD94-targeted CAR T-cell therapy, for patients with relapsed or refractory CD94-positive T/NK cell lymphomas. The IND authorization sets up early clinical testing of a new cellular approach aimed at a tightly defined immune-cell target. The trial initiation is notable because CD94 expression is relatively niche, which can narrow eligibility but also sharpen the rationale for efficacy and safety assessment. MD Anderson’s first-in-human work will focus on tolerability and dose escalation before expanding into efficacy evaluation. With IND now in hand, the next milestones for JV-394 are clinical dose-finding and early response signals, which will determine whether the program can progress toward later-stage development in this hard-to-treat indication.
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