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New Antibody-Chemo combo targets tough lymphoma

NCT ID NCT04984837

Disease control Sponsor: The Lymphoma Academic Research Organisation 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 This study
Running, but no longer taking on new participants.
Completed
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding the antibody lacutamab to standard chemotherapy (gemcitabine and oxaliplatin) helps people with relapsed or refractory peripheral T-cell lymphoma. About 49 adults whose tumors have a specific marker (KIR3DL2) will receive either the combination or chemotherapy alone. The study aims to see if the combination delays cancer progression and is safe.

What this could mean

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

Active substance
Lacutamab (an antibody) plus gemcitabine and oxaliplatin (chemotherapy)
What this could lead to
If successful, this could provide a new treatment option for people with certain types of T-cell lymphoma that have come back or not responded to prior therapy.
What could go wrong
This is a small, early-phase (Phase 2) trial with only 49 participants and no direct comparison between groups, so results may not be definitive. Side effects from the chemotherapy and antibody are possible.

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

49 people

The number who actually took part.

Started

Oct 2021

Expected to finish

Apr 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

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: * 1\. KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central evaluation by immunohistochemistry (IHC) 2. Patients with histologically documented PTCL: * Biopsy-proven treated PTCL defined by the WHO 2016 criteria (the biopsy at relapse is recommended but not mandatory): * PTCL-NOS * PTCL-TFH (AITL, Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype) * ALCL * ATL: acute- or lymphoma-type * HSTL * EATL * MEITL * NKT * ANKL 3. For patients with ALCL: previously treated with brentuximab vedotin 4. Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy (no mandatory latency after the previous treatment) 5. With a maximum of 2 prior lines of systemic therapies, including autologous stem cell transplantation (ASCT is authorized in first and second line and is not counted as a unique line, even if associated to a systemic therapy) 6. Bi-dimensionally measurable disease defined by at least one single node or tumor lesion ≥ 1.5 cm assessed by CT scan 7. Signed written screening informed consent prior to KIR3DL2 screening 8. Signed written study informed consent prior to randomization 9. Aged 18 years or more with no upper age limit, at randomization 10. Eastern Cooperative Oncology Group (ECOG) performance status 0 to 3 prior to prephase treatment (if applicable), and 0 to 2 prior randomization 11. Minimum life expectancy of 3 months 12. Females of childbearing potential (FCBP) must agree to use highly effective contraceptive method\* from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments 13. FCBP must have a negative serum or urinary pregnancy test within 28 days prior C1D1 14. Male patients and their partner (FCBP) must agree to use two reliable forms of contraception (condom for males and hormonal method for partners) from C1D1, during the entire study period, during dose interruptions, and for 9 months after the last study treatments Exclusion Criteria: * 1\. Patients with active COVID-19 infection (last positive PCR \< 2 weeks before randomization) 2. Patients taking immunotherapy or chemotherapy, except short-term corticosteroids in monotherapy at a cumulated dose equivalent of prednisone ≤ 1mg/kg/day, during 7 consecutive days, within 3 weeks prior to first administration of study drug (C1D1); or prephase treatment given at investigator's discretion before randomization and for maximum 3 weeks (glucocorticosteroids, vepesid (VP16), cyclophosphamide, vincristine and prednisone (COP)) 3. Previous treatment by Gemcitabine or Oxaliplatin 4. Use of any experimental anti-cancer drug therapy within 6 weeks before randomization 5. Contraindication to any drug contained in the study treatment regimen 6. Previous allogenic hematopoietic cell transplantation 7. Positive test results for HIV and Hepatitis C Virus (HCV) (Patients who are positive for HCV antibody must be negative for HCV by PCR to be eligible for study participation) 8. Known active hepatitis B (positive Ag HBs) (if latent Hepatitis B Virus (HBV) (positive anti-HBc), patients have to be treated with Entecavir (Baraclude ®) and HBV PCR should be performed every month to allow antiviral strategy adaptation) 9. Central nervous system or meningeal involvement by lymphoma 10. Any of the following laboratory abnormalities prior randomization: * Absolute neutrophil count (ANC) \< 1 G/L, unless neutropenia is related to PTCL * Platelet count \< 75 G/L, unless thrombopenia is related to PTCL * Alkaline Phosphatases \> 2.5 x upper limit of normal (ULN) * Serum Glutamoyl-oxaloacetate Transferase (SGOT) /Alanine aminotransferase (AST) or Serum Glutamate Pyruvate Transaminase (SGPT)/Alanine aminotransferase (ALT) \> 2.5 x ULN * Bilirubin \> 1.5 x ULN, unless SGOT/AST and SGPT/ALT \> 2.5 x ULN or bilirubin elevated due to PTCL or hemolysis * Calculated creatinine clearance (MDRD or Cockcroft) \< 40 mL/min 11. Any significant cardiovascular impairment: New York Heart Association (NYHA) Class III or IV cardiac disease, uncontrolled high blood pressure, unstable angina, myocardial infarction or stroke within the last 6 months from randomization, and cardiac arrhythmia within the last 3 months from randomization 12. Uncontrolled clinically significant intercurrent illness including, but not limited to, diabetes, ongoing active infections. Patients receiving antibiotics for infections that are under control may be included in the study 13. Concurrent malignancy or prior history of malignancies other than lymphoma unless the subject has been free of disease for ≥ 2 years, except early stage cutaneous squamous or basal cell carcinoma, localized prostate cancer, or cervical intraepithelial neoplasia 14. Major surgery within 4 weeks before randomization 15. Pregnant or lactating females

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Conditions

The condition(s) this trial relates to.

mature T-cell and NK-cell non-Hodgkin lymphoma Recurrence T-cell non-Hodgkin lymphoma

As listed by the trial registrant

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

Peripheral T-cell lymphoma Relapse/recurrence

Contacts and locations

Locations

  • A. Z. Sint-Jan

    Bruges, Belgium

  • APHP - Hopital Necker

    Paris, France

  • APHP - Hôpital Henri Mondor

    Créteil, France

  • APHP - Hôpital Saint Antoine

    Paris, France

  • APHP - Hôpital Saint Louis

    Paris, France

  • APHP - Hôpital de la Pitié Salpétrière

    Paris, France

  • CH Métropole Savoie

    Chambéry, France

  • CH d Avignon - Hopital Henri Duffaut

    Avignon, France

  • CH de Bretagne Atlantique - Hopital Chubert

    Vannes, France

  • CH de Dunkerque

    Dunkirk, France

  • CH de Mulhouse

    Mulhouse, France

  • CH de Perpignan

    Perpignan, France

  • CH de Périgueux

    Périgueux, France

  • CH de la Côte Basque - Hôpital de Bayonne

    Bayonne, France

  • CH du Mans

    Le Mans, 72000, France

  • CHD de Vendée

    La Roche-sur-Yon, France

  • CHR Verviers

    Verviers, Belgium

  • CHR d'Orléans

    Orléans, France

  • CHRU de Lille - Hôpital Claude Hurriez

    Lille, France

  • CHU Dinant Godinne - UCL Namur - YVOIR

    Yvoir, Belgium

  • CHU d'Amiens

    Amiens, France

  • CHU d'Angers

    Angers, France

  • CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

    Pessac, France

  • CHU de Caen - Côte de Nacre - IHBN

    Caen, France

  • CHU de Clermont Ferrand - Estaing

    Clermont-Ferrand, France

  • CHU de Dijon BOURGOGNE - Hôpital François Mitterand

    Dijon, France

  • CHU de Grenoble - Hôpital Albert Michallon

    La Tronche, France

  • CHU de LIEGE - Domaine Sart Tilman

    Liège, Belgium

  • CHU de Montpellier

    Montpellier, France

  • CHU de Nancy - Brabois

    Nancy, France

  • CHU de Nantes - Hôtel Dieu

    Nantes, France

  • CHU de Nîmes

    Nîmes, France

  • CHU de Poitiers - Hôpital de La Milétrie

    Poitiers, France

  • CHU de Reims

    Reims, France

  • CHU de Rennes - Hôpital de Pontchaillou

    Rennes, France

  • Centre Henri Becquerel

    Rouen, France

  • Centre Hospitalier Annecy Genevois

    Pringy, France

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, France

  • Centre Leon Berard

    Lyon, 69373, France

  • Ch de Versailles - Hopital Andre Mignot

    Le Chesnay, France

  • Charite Universitat Smedizin Berlin

    Berlin, Germany

  • Chu de Limoges - Hopital Dupuytren

    Limoges, France

  • Chu de Meaux

    Meaux, France

  • Clinique CHC MontLégia

    Liège, Belgium

  • Cliniques Universitaires de Bruxelles - Hôpital Erasme

    Brussels, Belgium

  • Cliniques universitaires Saint-Luc - Université catholique de Louvain

    Brussels, Belgium

  • GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizini

    Goettigen, Germany

  • Grand Hôpital de Charleroi

    Charleroi, Belgium

  • HELORA - Hôpital de La LouvièreSite Jolimont

    Haine-Saint-Paul, Belgium

  • Hospital Clínico Universitario de Valencia

    Valencia, Spain

  • Hospital Universitari Vall d'Hebron

    Barcelona, Spain

  • Hospital Universitario Fundacion Jimenez Diaz - Hematologia

    Madrid, Spain

  • Hospital Universitario Marqués de Valdecilla

    Santander, Spain

  • Hôpital Saint Vincent-De-Paul

    Lille, France

  • Institut Bergonié

    Bordeaux, France

  • Institut Jules Bordet

    Anderlecht, Belgium

  • Institut Universitaire du Cancer de Toulouse - Oncopole

    Toulouse, 31100, France

  • Institut de Cancerologie Strasbourg Europe

    Strasbourg, France

  • Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne

    Saint-Etienne, France

  • UNIVERSITAT LEIPZIG - Klinik fur Hamatologie, Zelltherapie und Hamostaseo

    Leipzig, Germany

  • UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

    Regensburg, Germany

  • UZ Antwerpen

    Edegem, Belgium

  • Universitatsklinikum Halle (Saale)

    Halle, Germany

  • VZW ZAS

    Antwerp, Belgium

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