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Lymphoma, T-CellPhase 2TELLOMAKNCT03902184

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

A Phase 2 study testing IPH4102 in people with Lymphoma, T-Cell and Lymphoma, T-Cell, Cutaneous, run by Innate Pharma at 53 sites in 8 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
Search all trials

Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
IPH4102
Could I receive a placebo?
No, everyone receives an active treatment
How many people
170 participants
Where
53 sitesin 8 countries
Study dates
22 May 2019to 8 Jan 2026
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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):
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  • 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;
  • 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;
  • 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;
  • Signed informed consent form prior to any protocol-specific procedures

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

53 sites in 8 countries.

53 sites in 8 countries

United States17 sites

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294

  • Dana-Farber Cancer Institute

    Boston, Massachusetts, 02215

  • Northwestern University The Feinberg School of Medicine

    Chicago, Illinois, 60611

  • Inova Health Care Services

    Fairfax, Virginia, 22031

  • Universal Dermatology, PLLC68

    Fairport, New York, 14450

  • MD Anderson Cancer Center

    Houston, Texas, 77030-4009

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

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

    Los Angeles, California, 90095

  • Columbia University Department of Dermatology

    New York, New York, 10032

  • Irvine Medical Center

    Orange, California, 92868

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • University of Pittsburgh School of Medicine

    Pittsburgh, Pennsylvania, 15208

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Stanford University

    Stanford, California, 94305

  • Moffitt Cancer Center

    Tampa, Florida, 33612

  • University of South Florida

    Tampa, Florida, 33612

Other trials in United States

France10 sites

  • CHU de Bordeaux Saint André

    Bordeaux, 33075

  • CHRU de Tours, Hôpital Trousseau

    Chambray-lès-Tours, 37170

  • CHU Henri Mondor

    Créteil, 94010

  • CHRU de Lille - Hopital Claude Huriez

    Lille, 59037

  • Centre Hospitalier Lyon-Sud

    Lyon, 69310

  • Institut Paoli-Calmettes

    Marseille, 13009

  • CHRU de Montpellier - Hopital Saint Eloi

    Montpellier, 34095

  • Hôpital Saint-Louis

    Paris, 75010

  • Hôpital Charles Nicolle-CHU de Rouen Clinique Dermatologie

    Rouen, 76031

  • IUCT Oncopôle

    Toulouse, 31100

Other trials in France

Germany8 sites

  • Charite - Universitaetsmedizin Berlin

    Berlin, 10115

  • Ruhr-University Bochum

    Bochum, 44791

  • Universitätsklinikum Frankfurt

    Frankfurt, 60590

  • Universitaetsklinikum Halle (Saale)

    Halle, 06120

  • Universitaetsklinikum Schleswig-Holstein Campus Kiel

    Kiel, 24105

  • Universitaetsmedizin Mannheim GmbH

    Mannheim, 68167

  • Johannes Wesling Klinikum Minden

    Minden, 32429

  • Universitaetsklinikum Muenster

    Münster, 48149

Other trials in Germany

Spain6 sites

  • Hospital del Mar

    Barcelona, 08003

  • Hospital Clinic Barcelona

    Barcelona, 08036

  • Hospital Universitario 12 de Octubre

    Madrid, 28041

  • Hospital Clinico Universitario de Salamanca

    Salamanca, 37007

  • Consorci Hospital General Universitari de Valencia Servicio de Dermatología

    Valencia, 46014

  • Hospital Universitari i Politecnic La Fe

    Valencia, 46026

Other trials in Spain

Italy4 sites

  • Institute of Hematology "Seràgnoli", Univeristy of Bologna

    Bologna, 40138

  • ASST degli Spedali Civili di Brescia

    Brescia, 25123

  • Istituto Dermopatico dell'Immacolata (IDI-IRCCS)

    Roma, 00167

  • Universita di Torino, Ospedale le Molinette

    Turin, 10126

Other trials in Italy

Belgium3 sites

  • Institut Jules Bordet

    Brussels, 1070

  • UZ Leuven - campus Gasthuisberg

    Leuven, 3000

  • Centre Hospitalier Universitaire (CHU) de Liege

    Liège, 4000

Other trials in Belgium

Poland3 sites

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

    Gdansk, 80-214

  • CET Centrum Medyczne Pratia Poznan ul. Poznanska 14

    Skorzewo, 60-185

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

    Warsaw, 02-781

Other trials in Poland

Austria2 sites

  • Universitätsklinik für Dermatologie Medizinische Universität Graz

    Graz, A-8036

  • Medizinische Universitaet Wien

    Vienna, 1090

Other trials in Austria

About this study

Official title: TELLOMAK: T-cell Lymphoma Anti-KIR3DL2 Therapy. An Open Label, Multicohort, 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

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.

Being tested
IPH4102
Medical subject headings
Lymphoma, T-Cell, Lymphoma, T-Cell, Cutaneous, Mycosis Fungoides, Sezary Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • IPH4102Biological

    Also called lacutamab

    Patients will receive a flat dose of 750mg

Study groups in NCT03902184
Study groupRoleWhat they receive
Cohort 1: Relapsed/refractory Sezary SyndromeExperimentalIPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Receives: Biological: IPH4102
Cohort 2: Stage IB-IV Mycosis Fungoides, KIR3DL2 expressingExperimentalIPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Receives: Biological: IPH4102
Cohort 3: Stage IB-IV Mycosis Fungoides,KIR3DL2 non-expressing (closed)ExperimentalIPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Receives: Biological: IPH4102
Cohort All comers: Stage IB-IV Mycosis Fungoides,KIR3DL2 expressing and non-expressingExperimentalIPH4102 will be administered every week for 5 weeks then every 2 weeks for 10 administrations then every 4 weeks until disease progression or unacceptable toxicity.
Receives: Biological: IPH4102

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Objective Response Rate (ORR)

    Using the Olsen (2011, JCO) criteria (All cohorts)

    Measured: From the first dose until study completion, an expected average of 2 years

Secondary outcomes (10)

  1. Incidence of Treatment-Emergent Adverse Events (Safety and tolerability) (All cohorts)

    patients with treatment-related adverse events as assessed by CTCAE v5.0

    Measured: From first dose until study completion, an expected average of 2 years

  2. Quality of life (QoL) (All cohorts)

    Using the Skindex29 questionnaire to assesse the effects of skin disease on quality of life in three domains: Symptoms, Emotions, and Functioning

    Measured: Through study completion, an expected average of 2 years

  3. pruritus (All cohorts)

    Using Visual Analog Scale (VAS) for prutitus assessment: From 0 = No pruritus to 10 = Pruritus as bad as it could possibly be

    Measured: Through study completion, an expected average of 2 years

  4. ORR using blinded central review (Cohort 1)

    Using the Olsen (2011, JCO) criteria

    Measured: From the first dose until study completion, an expected average of 2 years

  5. Progression free survival (PFS) (All cohorts)

    Will be evaluated using the Kaplan-Meier method

    Measured: From the first dose until study completion, an expected average of 2 years

  6. Overall survival (OS) (All cohorts)

    Will be evaluated using the Kaplan-Meier method

    Measured: From the first dose until study completion, an expected average of 2 years

  7. PK parameters : Maximum Plasma Concentration of IPH4102 alone (All cohorts)

    Maximum Plasma Concentration (Cmax) (W1, W5)

    Measured: From the first dose until study completion, an expected average of 2 years

  8. PK parameters :Trough Concentration of IPH4102 alone (All cohorts)

    Trough Concentration (Ctrough) every 8 or 12 weeks

    Measured: From the first dose until study completion, an expected average of 2 years

  9. Immunogenicity of IPH4102 alone (All cohorts)

    A serum sample will be collected at the specified time points for evaluation of anti-drug antibodies (ADA).

    Measured: From the first dose until study completion, an expected average of 2 years

  10. Duration of Response (DOR)

    Will be summarized descriptively by using the Kaplan-Meier estimator

    Measured: From the first dose until study completion, an expected average of 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted3 Apr 2019
  2. Study start22 May 2019
  3. Primary completion8 Jan 2026
  4. Study completion8 Jan 2026

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
170 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03902184
Sponsor's protocol ID
IPH4102-201
Other IDs
2023-507777-18-00, 2018-003969-33, 2018, 2023
Acronym
TELLOMAK
Status last verified
Apr 2026
First submitted
14 Mar 2019
Last updated
29 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing IPH4102 in people with Lymphoma, T-Cell and Lymphoma, T-Cell, Cutaneous, run by Innate Pharma at 53 sites in 8 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 28 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 29 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 53 sites in United States, France, Germany, Spain, Italy and 3 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate (ORR) (time frame: From the first dose until study completion, an expected average of 2 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03902184.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Apr 2026.

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