IPH4102/Lacutamab Alone or in Combination With Chemotherapy in Patients With Advanced T Cell Lymphoma

Completed · Phase 2

Conditions studied: Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides/Sezary Syndrome

In brief

This is an open label, multi-cohort, and multi-center phase II study, which evaluates the clinical activity and safety of IPH4102 in Sezary Syndrome and Mycosis fungoides as single agent.

Key facts

Study ID: NCT03902184
Run by: Innate Pharma
People needed: 170
Starts: 2019-05-22
Expected to finish: 2026-01-08
Last updated by the study team: 2026-04-29

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

SS patients (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;
MF patients (Cohorts 2 and All comers):
Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF;
Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC;
Patients should have received at least two prior systemic therapies;
Feasibility of obtaining at least one skin biopsy at screening;
Additional inclusion criteria applicable to all cohorts:
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;
Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia;
Adequate baseline laboratory data:
Hematology:
Hemoglobin >9 g/dL,
Absolute neutrophil count (ANC) ≥1,500/µL,
Platelets ≥100,000/µL,
Biochemistry:
Bilirubin ≤1.5 X upper limit of normal (ULN) or ≤3 X ULN for patients with Gilbert's disease,
Serum creatinine ≤1.5 X ULN,
Creatinine clearance ≥30 mL/min, calculated with the Cockcroft \& Gault formula,
Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≤2.5 X ULN;

You may not qualify if…

Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening;
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;
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 Hepatitis B Virus infection determined as HBsAg positive and / or Hepatitis C Virus infection determined as detection of HCV RNA in serum or plasma by a sensitive quantitative molecular method;
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: non-melanoma 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;
Known clinically significant cardiovascular disease or condition, including:
Class III or IV cardiovascular disease according to the New York Heart Association (NYHA) Functional Classification;
Any uncontrolled arrhythmia (per the investigator's discretion);
Uncontrolled hypertension (per the investigator's discretion).
Patients with autoimmune disease on systemic immunosuppressive treatment;
Patients with any serious underlying medical condition that would impair their ability to receive or tolerate the planned treatment and/or comply with study protocol;
Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.

Where it is running

University of California, Los Angeles (UCLA) - Medical Center — Los Angeles, California, United States
Irvine Medical Center — Orange, California, United States
Stanford University — Stanford, California, United States
Moffitt Cancer Center — Tampa, Florida, United States
University of South Florida — Tampa, Florida, United States
Northwestern University The Feinberg School of Medicine — Chicago, Illinois, United States
Dana-Farber Cancer Institute — Boston, Massachusetts, United States
Washington University School of Medicine — St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center — Lebanon, New Hampshire, United States
Universal Dermatology, PLLC68 — Fairport, New York, United States
Columbia University Department of Dermatology — New York, New York, United States
University of Pennsylvania — Philadelphia, Pennsylvania, United States
Thomas Jefferson University — Philadelphia, Pennsylvania, United States
University of Pittsburgh School of Medicine — Pittsburgh, Pennsylvania, United States
MD Anderson Cancer Center — Houston, Texas, United States
Inova Health Care Services — Fairfax, Virginia, United States
Universitätsklinik für Dermatologie Medizinische Universität Graz — Graz, Austria
Medizinische Universitaet Wien — Vienna, Austria
Institut Jules Bordet — Brussels, Belgium
UZ Leuven - campus Gasthuisberg — Leuven, Belgium
Centre Hospitalier Universitaire (CHU) de Liege — Liège, Belgium
CHU de Bordeaux Saint André — Bordeaux, France
CHRU de Tours, Hôpital Trousseau — Chambray-lès-Tours, France
CHU Henri Mondor — Créteil, France
University of Alabama at Birmingham — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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