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8110 Gatehouse Road, Falls Church, VA 22042

T-cell Lymphoma anti-KIR3DL2 therapy - An open label, multi-cohort, multi-center phase II study evaluating the efficacy and safety of IPH4102 alone or in combination with chemotherapy in patients with Advanced T-cell lymphoma (Tellomak)

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General Information

Age Group

Adults

Status

Recruiting

Protocol Number

NCT03902184

Background Information

The purpose of this study is to evaluate the effectiveness and safety of a new experimental drug named IPH4102.

IPH4102 is an antibody. Antibodies are proteins which are produced by cells of the immune system, the body’s defense system. They recognize foreign or unwanted material, such as bacteria, viruses or certain surface proteins of lymphoma cells. One part of IPH4102 recognizes and binds a protein called KIR3DL2 on the surface of tumor cells and another part binds to a specific kind of immune cells, called Natural Killer (NK) cells. When the tumor cell and the NK cell are connected by IPH4102, the NK cell will destroy the tumor cell.

Patients participating in this study will be enrolled in one of three cohorts:

  • In cohort 1: Patients with Sézary syndrome (SS)
  • In cohorts 2 and 3: Patients with mycosis fungoides (MF).

Patients with mycosis fungoides (MF) will be allocated to either cohort 2 or cohort 3 according to the result of a test called “KIR3DL2 expression."

Offered At

Inova Schar Cancer Institute
8081 Innovation Park Dr.
Fairfax, VA 22031

A department of Inova Fairfax Hospital

Eligibility Information

For Cohort 1:

  • Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies
  • Prior treatment with mogamulizumab
  • Patients should have blood stage B2 at screening based on central evaluation by flow cytometry
  • Feasibility of obtaining at least one skin biopsy at screening

For Cohorts 2 and 3:

  • Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF
  • KIR3DL2 expression (Cohort 2) or non-expression (Cohort 3) in at least one skin lesion based on central evaluation
  • Patients should have received at least two prior systemic therapies; o Feasibility of obtaining at least one skin biopsy at screening

Other Eligibility Information:

  • Male or Female, at least 18 years of age
  • ECOG performance status ≤2
  • The patient must have a minimum wash-out period of 3 weeks between the last dose of prior systemic therapy and the first dose of IPH4102, except for mogamulizumab, a washout period of at least 8 weeks is required
  • Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia
  • Additional eligibility in protocol

Ineligibility Information

  • Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening
  • Concomitant corticosteroid use, systemic or topical. However, stable dosage of topical steroids (maximum strength Class III according to World Health Organization (WHO) Classification of Topical Corticosteroids) and/or systemic steroids (≤10 mg prednisone equivalent/day) are allowed, if patient has been on a stable dose for at least 4 weeks prior to treatment start. Inhaled steroids are allowed provided the presence of a concomitant medical condition that justifies the use
  • Receipt of live vaccines within 4 weeks prior to treatment
  • Central nervous system (CNS) lymphoma involvement
  • Prior administration of IPH4102
  • Concurrent enrollment in another clinical trial, unless it is an observational (non -interventional) clinical study or the follow-up period of an interventional study
  • Concomitant administration of radiotherapy or systemic anti-cancer therapy including but not restricted to: chemotherapy, biological agents, extracorporeal photopheresis (ECP) or immunotherapy
  • Autologous stem cell transplantation less than 3 months prior to enrollment
  • Prior allogenic transplantation
  • Patients who have undergone major surgery ≤ 4 weeks prior to study entry
  • Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection
  • Patients who have active Hepatitis B or C virus infection
  • Known or tested positive for human immunodeficiency virus (HIV)
  • Patients with a history of other malignancies during the past five years apart from the disease subject of this study. The following are exempt from the five-year limit: nonmelanoma skin cancer, lymphomatoid papulosis, resected thyroid cancer, biopsy-proven cervical intraepithelial neoplasia, Ductal carcinoma in situ (DCIS) or cervical carcinoma in situ
  • Pregnant or breastfeeding women
  • Patients with congestive heart failure, Class III or IV, by New York Heart Association (NYHA) criteria
  • Additional ineligibility in protocol

Additional information can be found at: https://clinicaltrials.gov/ct2/show/NCT03902184