Phase I study of IPH4102 treatment in patients with CTCL
Research type
Research Study
Full title
Open label, multicenter phase I study of IPH4102, a humanized anti-KIR3DL2 monoclonal antibody, in patients with relapsed/refractory cutaneous T-cell lymphomas (CTCL)
IRAS ID
182530
Contact name
Sean Whittaker
Contact email
Sponsor organisation
INNATE PHARMA
Eudract number
2015-000260-34
Duration of Study in the UK
4 years, 1 months, 30 days
Research summary
Cutaneous T-cell lymphoma (CTCL) is a rare cancer caused by T-cells (cells that are vital to the immune system) in the skin growing in an uncontrolled way. There are different types of CTCL, Mycosis fungoides (MF) is the most common and is a very slow growing form of CTCL only affecting the skin. Sezary syndrome involves abnormal T-cells in the blood too and is considered as an advanced form of MF.
CTCL causes changes in the skin such as red rash-like patches, itchiness, lumps and raised plaques. The causes of CTCL are unknown.
There is no known cure for CTCL. Current treatments for early-stage CTCL include applying creams directly to the skin, radiotherapy, and UV light, whereas advanced-stage patients require chemotherapy to work throughout the whole body.
Innate Pharma have developed a new drug, IPH4102, an antibody (protein which neutralizes foreign substances, such as bacteria or infection) which recognizes and binds to human protein KIR3DL2. KIR3DL2 has been found to be present on CTCL cells. On normal cells, KIR3DL2 is expressed on minor subsets of lymphocytes (cells from the immune system), but is absent from any other human tissue.
This study is being carried out to evaluate how well IPH4102 is tolerated in patients with CTCL and which side effects will occur when IPH4102 is administered (‘dose-escalation’ part) to determine a dose for further studies, as well as to assess antitumour activity (‘cohort-expansion’ part).
This is an open-label, phase I study with participants receiving 1 of 10 increasing doses of IPH4102 once a week for 4 weeks via intravenous injection (into the vein), followed by further treatment depending on clinical benefit.
This is a multicentre study which will take place across Europe and United States. It is anticipated that approximately 60 patients (men and women ≥ 18 years) with CTCL will be enrolled worldwide across both parts of the study.REC name
London - Chelsea Research Ethics Committee
REC reference
15/LO/1502
Date of REC Opinion
8 Oct 2015
REC opinion
Further Information Favourable Opinion