Study of a Humanized Antibody Initiated 2 Months After an HLA Matched Allogenic Stem Cell Transplantation

Sponsor
Institut Paoli-Calmettes
Study ID
NCT02921685
Phase
PHASE1
Status
Unknown

Conditions

  • Hematologic Malignancies

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Nov 28, 2016
Status verified
Sep 2018
Primary completion
May 28, 2019
Completion
Apr 28, 2020

Study Design

Enrollment
18 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Monalizumab
    Monalizumab treatment will be initiated 75 to 100 days after hematopoietic stem cells transplantation. Patients will receive a single dose of monalizumab by intravenous route over 1 hour.

Primary Outcome Measure

Occurence ratio of dose-limiting toxicity (DLT) [ Time Frame: 4 weeks ]

Central Contacts

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