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New antibody shows promise for rare blood cancers

NCT ID NCT03902184

Disease control Sponsor: Innate Pharma Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tested a drug called lacutamab (IPH4102) in 170 people with advanced T-cell lymphoma, including Sezary syndrome and mycosis fungoides. The drug is an antibody that targets a protein on cancer cells. It was given alone or with chemotherapy to see if it could shrink tumors and improve quality of life. The study is now complete, and results will show how safe and effective the treatment is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
lacutamab (IPH4102), a targeted antibody
What this could lead to
If successful, this could provide a new treatment option for people with advanced T-cell lymphoma who have not responded to other therapies.
What could go wrong
This is a phase 2 trial, so results are still early. The drug may not work for all patients, and side effects are possible. Further studies are needed before it becomes widely available.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

170 people

The number who actually took part.

Started

May 2019

Finished

Jan 2026

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion criteria SS patients (Cohort 1): 1. Relapsed and/or refractory stage IVA, IVB SS who have received at least two prior systemic therapies; 2. Prior treatment with mogamulizumab; 3. Patients should have blood stage B2 at screening based on central evaluation by flow cytometry; 4. Feasibility of obtaining at least one skin biopsy at screening; MF patients (Cohorts 2 and All comers): 5. Relapsed and/or refractory stage IB, IIA, IIB, III, IV MF; 6. Only for Cohort 2: KIR3DL2 expression in at least one expressing skin lesion based on central evaluation by IHC; 7. Patients should have received at least two prior systemic therapies; 8. Feasibility of obtaining at least one skin biopsy at screening; Additional inclusion criteria applicable to all cohorts: 9. Male or Female, at least 18 years of age; 10. ECOG performance status ≤2; 11. 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; 12. Patients should have recovered from all non-hematological adverse events related to prior therapy to ≤ grade 1 except for alopecia; 13. 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; 14. Women of childbearing potential (WOCBP): Premenopausal females who had at least one menstrual cycle in the past 12 months and capable to become pregnant. They must have a negative serum beta-HCG pregnancy test result within seven days from start of treatment; 15. Women of childbearing potential and all men (and their female partners of childbearing potential) who are sexually active must agree to use adequate method of contraception at study entry, during treatment and for at least 9 months (270 days) following the last dose of study drug; 16. Signed informed consent form prior to any protocol-specific procedures Exclusion Criteria: 1. Patients with evidence of large cell transformation (LCT) based on central histologic evaluation at screening; 2. Receipt of live vaccines within 4 weeks prior to treatment; 3. Central nervous system (CNS) lymphoma involvement; 4. Prior administration of IPH4102; 5. Concurrent enrollment in another clinical trial, unless it is an observational (non - interventional) clinical study or the follow-up period of an interventional study; 6. Autologous stem cell transplantation less than 3 months prior to enrollment; 7. Prior allogenic transplantation; 8. Patients who have undergone major surgery ≤ 4 weeks prior to study entry; 9. Patients with known NCI CTCAE grade 3 or higher active systemic or cutaneous viral, bacterial, or fungal infection; 10. 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; 11. Known or tested positive for human immunodeficiency virus (HIV); 12. 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 13. Pregnant or breastfeeding women; 14. 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). 15. Patients with autoimmune disease on systemic immunosuppressive treatment; 16. 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; 17. Patients with dementia or altered mental status that would preclude understanding and rendering of informed consent document.

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Conditions

The condition(s) this trial relates to.

mycosis fungoides primary cutaneous T-cell non-Hodgkin lymphoma Sezary syndrome T-cell non-Hodgkin lymphoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Lymphoma, T-cell Lymphoma, T-cell, cutaneous Mycosis fungoides/sezary syndrome

Contacts and locations

Locations

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123, Italy

  • CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

    Skorzewo, 60-185, Poland

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037, France

  • CHRU de Montpellier - Hopital Saint Eloi

    Montpellier, 34095, France

  • CHRU de Tours, Hôpital Trousseau

    Chambray-lès-Tours, 37170, France

  • CHU Henri Mondor

    Créteil, 94010, France

  • CHU de Bordeaux Saint André

    Bordeaux, 33075, France

  • Centre Hospitalier Lyon-Sud

    Lyon, 69310, France

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège, 4000, Belgium

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10115, Germany

  • Columbia University Department of Dermatology

    New York, New York, 10032, United States

  • Consorci Hospital General Universitari de Valencia Servicio de Dermatología

    Valencia, 46014, Spain

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756, United States

  • Hospital Clinic Barcelona

    Barcelona, 08036, Spain

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007, Spain

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026, Spain

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital del Mar

    Barcelona, 08003, Spain

  • Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

    Rouen, 76031, France

  • Hôpital Saint-Louis

    Paris, 75010, France

  • IUCT Oncopôle

    Toulouse, 31100, France

  • Inova Health Care Services

    Fairfax, Virginia, 22031, United States

  • Institut Jules Bordet

    Brussels, 1070, Belgium

  • Institut Paoli-Calmettes

    Marseille, 13009, France

  • Institute of Hematology "Seràgnoli", Univeristy of Bologna

    Bologna, 40138, Italy

  • Irvine Medical Center

    Orange, California, 92868, United States

  • Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

    Roma, 00167, Italy

  • Johannes Wesling Klinikum Minden

    Minden, 32429, Germany

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009, United States

  • Medizinische Universitaet Wien

    Vienna, 1090, Austria

  • Moffitt Cancer Center

    Tampa, Florida, 33612, United States

  • Narodowy Instytut Onkologii im. Marii Sklodowskiej-Curie - Panstwowy Instytut Badawczy, Klinika Nowotworow Ukladu Chlonnego

    Warsaw, 02-781, Poland

  • Northwestern University The Feinberg School of Medicine

    Chicago, Illinois, 60611, United States

  • Ruhr-University Bochum

    Bochum, 44791, Germany

  • Stanford University

    Stanford, California, 94305, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • UZ Leuven - campus Gasthuisberg

    Leuven, 3000, Belgium

  • Universal Dermatology, PLLC68

    Fairport, New York, 14450, United States

  • Universita di Torino, Ospedale le Molinette

    Turin, 10126, Italy

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120, Germany

  • Universitaetsklinikum Muenster

    Münster, 48149, Germany

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105, Germany

  • Universitaetsmedizin Mannheim GmbH

    Mannheim, 68167, Germany

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

  • University of California, Los Angeles (UCLA) - Medical Center

    Los Angeles, California, 90095, United States

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104, United States

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15208, United States

  • University of South Florida

    Tampa, Florida, 33612, United States

  • Universitätsklinik für Dermatologie Medizinische Universität Graz

    Graz, A-8036, Austria

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590, Germany

  • Uniwersyteckie Centrum Kliniczne, Klinika Dermatologii, Wenerologii i Alergologii ul. Smoluchowskiego 17

    Gdansk, 80-214, Poland

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.