Study of Isatuximab and Cemiplimab in Relapsed or Refractory Natural Killer/T-cell Lymphoid Malignancy
Status:
Recruiting
Trial end date:
2026-04-30
Target enrollment:
Participant gender:
Summary
This study is to analyze the efficacy of PD1 inhibitor and anti-CD38 antibody in relapsed or
refractory NK/T-cell lymphoid malignancy. The investigational products of this study are
cemiplimab (PD1 inhibitor) and isatuximab (anti-CD38 antibody).
The rationale for the use of cemiplimab in patients with NK/T-cell lymphoid malignancy is the
aforementioned PD-L1 expression in tumor cells of ENKTL and ANKL. In addition, the proven
efficacy of pembrolizumab in relapsed or refractory ENKTL support the use of PD1 inhibitor as
a salvage therapy for this disorder.
The addition of isatuximab to cemiplimab might induce synergistic activity because
CD38-mediated immunosuppression as a mechanism of tumor cell escape from PD-1/PD-L1 blockade.
Furthermore, targeting CD38 by isatuximab can preferentially block immunosuppressive
regulatory T-cells and thereby restore immune effector function against multiple myeloma.
These functions of CD38 blocking antibody might help to improve the efficacy of immune
checkpoint inhibitor such as PD1 inhibitor.
Given the presence of antibody-mediated cytotoxicity and direct anti-tumor effect of
isatuximab against CD38-positive tumor cells, the combination of isatuximab with cemiplimab
might show the synergistic activity resulting more improved treatment outcome than PD1
inhibitor alone.
Thus, The investigators designed a phase II study of cemiplimab and isatuximab for patients
with relapsed or refractory ENKTL and ANKL. In this study, The investigators analyze the
efficacy of this novel combination and their adverse effects.