Hematologic Malignancies Clinical Trial
Official title:
A Phase 1 Study of MONALIZUMAB (IPH2201), a Humanized Anti CD94/NKG2A Monoclonal Antibody (Mab) Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation (SCT) Prepared With a Reduced Intensity Conditioning
This study will determine the Maximal Tolerated Dose if any and the recommended dose for phase 2 of monalizumab, a monoclonal antibody directed against the CD94/NKG2A receptor, after allogenic stem cell transplantation. All patients will receive one single intravenous administration of one of the four doses of monalizumab.
Allogeneic hematopoietic stem cell transplantation (Allo-HSCT) is a curative option for most
of hematological malignancies, though the graft-versus-tumor (GVT) effect mediated by immune
cells from the donor. However, the use of Allo-HSCT is limited by its toxicity, notably the
graft-versus-host disease (GVHD) that is a major cause of non-relapse mortality (NRM).
Conditioning regimens dramatically improved during the last fifteen years, with a decrease of
both GVHD and NRM rates. Now, disease recurrence after Allo-HSCT is the first cause of
treatment failure and remains a concern for approximately 30% of the patients.
Based on a safety immunologic platform (ATG based reduced toxicity conditioning regimens), it
is needed to develop post Allo-HSCT strategies to decrease the incidence of relapse. In this
context, the modulation of immune cell activity could play a role to prevent relapse. NK
cells have a unique capacity to exert potent GVT effects without inducing GVHD. Moreover, NK
cells recovery occurs early after Allo-HSCT and NK cells function are not severely impaired
by the use of ciclosporin A, that is given for few months after Allo-HSCT as GVHD
prophylaxis. Thus, NK cell modulation appears as a viable option for early immune
intervention after Allo-HSCT.
Monalizumab (IPH2201), a monoclonal antibody has a non-depleting and purely blocking activity
directed with high affinity and specificity against the CD94/NKG2A receptor expressed by
subsets of NK cells, activated αβ CD8+ T cells, γδ-T cells and NK T cells. By suppressing the
inhibitory signal transduced by NKG2A, IPH2201 enhances the anti-tumor functions, including
cytolytic activity of these immune effector cells.The aim of the study is to determine the
safety of IPH2201 after allogenic stem cell transplantation.
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