No Dose-Limiting Toxicities Seen with AgenT-797 in Myeloma

By Cecilia Brown - Last Updated: November 15, 2022

No dose-limiting toxicities occurred in patients with relapsed/refractory multiple myeloma (MM) who were treated with agenT-797, a novel allogeneic invariant natural killer T-cell therapy, according to a presentation at the 2022 Society for Immunotherapy of Cancer Annual Meeting.

AgenT-797 is a “scalable, off-the-shelf therapy that retains potent cytotoxicity after cryopreservation,” the authors, led by Don Stevens, MD, of the Norton Cancer Institute, wrote.

The researchers analyzed data from two ongoing phase I studies of agenT-797, one of which evaluated it as a monotherapy in 12 patients with relapsed/refractory MM, while the other assessed agenT-797 alone or in combination with pembrolizumab or nivolumab in 25 patients with relapsed/refractory solid tumors.

Patients with relapsed/refractory MM received agenT-797 at dose levels of 1.4×106 cells/kg (n=3), 4.3×106 cells/kg (n=6), or 1.4×107 cells/kg (n=3) after having failed at least three prior treatments, including a proteasome inhibitor, immunomodulatory agent, and an anti-CD38 antibody. They received a single dose of agenT-797, without lymphodepletion, in two dose-escalating cohorts. These patients had a median age of 55 years and received a median of five prior lines of therapy. Of the 12 patients treated, eight were evaluable (see TABLE 1).

TABLE 1. AgenT-797 Dose Levels and Best Overall Responses in Patients with Relapsed/Refractory Multiple Myeloma
Patient AgenT-797 Dose Prior Lines of Therapy Prior Immunotherapies Best Overall Response
1 1.4×106 cells/kg 6 Daratumumab, nivolumab Stable disease for 10 months
2 1.4×106 cells/kg 6 Daratumumab, elotuzumab Progressive disease
3 1.4×106 cells/kg 4 Daratumumab Progressive disease
4 4.3×106 cells/kg 4 Daratumumab Progressive disease
5 4.3×106 cells/kg 3 Daratumumab Progressive disease
6 4.3×106 cells/kg 7 Daratumumab, elotuzumab Stable disease for two months with response ongoing
7 1.4×107 cells/kg 2 Daratumumab Progressive disease
8 1.4×107 cells/kg 6 Daratumumab Progressive disease


No dose-limiting toxicities occurred with agenT-797. The lack of dose-limiting toxicities indicates that agenT-797 has “favorable” tolerability in patients with relapsed/refractory MM, according to Dr. Stevens and colleagues.

AgenT-797 “can be administered without lymphodepletion, is tolerable in patients with [relapsed/refractory] MM after at least three prior lines of therapy and shows early signals of durable disease stabilization,” they concluded.


Stevens D, Mo C, Garmezy B, et al. Phase I studies of agenT-797, a novel allogeneic invariant natural killer T (iNKT) cell therapy, for the treatment of patients with solid tumors or multiple myeloma. Abstract #647. Presented at the 2022 Society for Immunotherapy of Cancer Annual Meeting; November 8-12, 2022, Boston, MA.

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