AGENT-797 in Patients With Relapsed/Refractory Multiple Myeloma

Summary

Participation Requirements

Description

This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D. In Part 1, the study will employ a s...

This is a Phase I, open-label, dose-escalation, single arm study to explore the safety, tolerability, and preliminary clinical activity of agenT-797, an unmodified, allogeneic iNKT cell therapy, in subjects with relapsed/refractory MM, as well as define the RP2D. In Part 1, the study will employ a standard 3+3 dose escalation design, for which 3 to 6 evaluable subjects (maximally 9 if recommended by the Safety Review Committee [SRC]) will be enrolled at each assigned dose level, per cohort depending on the occurrence of DLTs. Part 2 will consist of one or more cohorts of in total up to around 6 to 12 subjects with relapsed/refractory MM who receive agenT-797 at a given dose after lymphodepletion and will employ a 3+3 dose escalation/de-escalation design depending on the occurrence of DLTs. The starting dose in Part 2 will be equal to the maximum tolerated dose (MTD) defined in Part 1 in the absence of any DLTs at that dose level. If a DLT is observed at the MTD in Part 1, the starting dose level in Part 2 will be the dose level below MTD. Details of the analyses will be described in a statistical analysis plan. A Safety Monitoring Committee will be established to assess safety and decide on escalation to next Cohort.

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