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Study of Lacutamab in Peripheral T-cell Lymphoma

NCT ID: NCT04984837

Last Updated: 2025-08-01

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE2

Total Enrollment

56 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-10-05

Study Completion Date

2028-01-30

Brief Summary

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This is an open-label multicenter randomized non comparative phase II study to evaluate the safety and efficacy of the monoclonal anti-KIR3DL2 antibody Lacutamab in patients with Refractory/Relapsing (R/R) KIR3DL2 positive Peripheral T Cell Lymphoma (PTCL) : Not Other Specified (NOS), PTCL-TFH (including Angioimmunoblastic T-cell Lymphoma (AITL), Follicular T-cell lymphoma, Nodal peripheral T-cell lymphoma with TFH phenotype), Anaplastic large cell lymphoma (ALCL), Adult T-cell leukemia/lymphoma (ATL), Hepatosplenic T-cell lymphoma (HSTL), Enteropathy-associated T-cell lymphoma (EATL), Monomorphic epitheliotropic intestinal T cell lymphoma (MEITL), NK-T cell lymphoma (NKT) and Aggressive NK-cell leukemia (ANKL).

The design is non comparative meaning that non comparison between arms will be performed as the control arm will ensure that the assumptions used for sample size calculation are verified. For that reason, randomization is unbalanced in favor of the experimental arm (2:1).

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Detailed Description

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Conditions

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Peripheral T Cell Lymphoma Relapse/Recurrence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Lacutamab

Lacutamab 750 mg/IV + GEmOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase Lacutamab 750 mg/IV for a maximum of 20 additional cycles of 4 weeks during the maintenance phase

Group Type EXPERIMENTAL

Lacutamab

Intervention Type DRUG

750 mg/IV

Gemcitabine

Intervention Type DRUG

1000 mg/m²

Oxaliplatine

Intervention Type DRUG

100 mg/m²

Standard of care

GemOx (1000 mg/m² / 100 mg/m²) 6 cycles of 3 weeks (4,5 months) during the induction phase

Group Type ACTIVE_COMPARATOR

Gemcitabine

Intervention Type DRUG

1000 mg/m²

Oxaliplatine

Intervention Type DRUG

100 mg/m²

Interventions

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Lacutamab

750 mg/IV

Intervention Type DRUG

Gemcitabine

1000 mg/m²

Intervention Type DRUG

Oxaliplatine

100 mg/m²

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Innate Pharma

INDUSTRY

Sponsor Role collaborator

The Lymphoma Academic Research Organisation

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Morgane Cheminant

Role: STUDY_CHAIR

Lymphoma Study Association

Locations

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Institut Jules Bordet

Anderlecht, , Belgium

Site Status RECRUITING

VZW ZAS

Antwerp, , Belgium

Site Status RECRUITING

A. Z. Sint-Jan

Bruges, , Belgium

Site Status RECRUITING

Cliniques Universitaires de Bruxelles - Hôpital Erasme

Brussels, , Belgium

Site Status SUSPENDED

Cliniques universitaires Saint-Luc - Université catholique de Louvain

Brussels, , Belgium

Site Status RECRUITING

Grand Hôpital de Charleroi

Charleroi, , Belgium

Site Status RECRUITING

UZ Antwerpen

Edegem, , Belgium

Site Status RECRUITING

HELORA - Hôpital de La LouvièreSite Jolimont

Haine-Saint-Paul, , Belgium

Site Status RECRUITING

CHU de LIEGE - Domaine Sart Tilman

Liège, , Belgium

Site Status RECRUITING

Clinique CHC MontLégia

Liège, , Belgium

Site Status RECRUITING

CHR Verviers

Verviers, , Belgium

Site Status RECRUITING

CHU Dinant Godinne - UCL Namur - YVOIR

Yvoir, , Belgium

Site Status RECRUITING

CHU de Nancy - Brabois

Nancy, France, France

Site Status RECRUITING

CHU d'Amiens

Amiens, , France

Site Status RECRUITING

CHU d'Angers

Angers, , France

Site Status RECRUITING

CH d Avignon - Hopital Henri Duffaut

Avignon, , France

Site Status RECRUITING

CH de la Côte Basque - Hôpital de Bayonne

Bayonne, , France

Site Status RECRUITING

Institut Bergonié

Bordeaux, , France

Site Status RECRUITING

CHU de Caen - Côte de Nacre - IHBN

Caen, , France

Site Status RECRUITING

CH Métropole Savoie

Chambéry, , France

Site Status RECRUITING

CHU de Clermont Ferrand - Estaing

Clermont-Ferrand, , France

Site Status RECRUITING

APHP - Hôpital Henri Mondor

Créteil, , France

Site Status RECRUITING

CHU de Dijon BOURGOGNE - Hôpital François Mitterand

Dijon, , France

Site Status RECRUITING

CH de Dunkerque

Dunkirk, , France

Site Status RECRUITING

CHD de Vendée

La Roche-sur-Yon, , France

Site Status RECRUITING

CHU de Grenoble - Hôpital Albert Michallon

La Tronche, , France

Site Status RECRUITING

Ch de Versailles - Hopital Andre Mignot

Le Chesnay, , France

Site Status RECRUITING

CH du Mans

Le Mans, , France

Site Status RECRUITING

CHRU de Lille - Hôpital Claude Hurriez

Lille, , France

Site Status RECRUITING

Hôpital Saint Vincent-De-Paul

Lille, , France

Site Status RECRUITING

Chu de Limoges - Hopital Dupuytren

Limoges, , France

Site Status RECRUITING

Centre Leon Berard

Lyon, , France

Site Status RECRUITING

Chu de Meaux

Meaux, , France

Site Status RECRUITING

CHU de Montpellier

Montpellier, , France

Site Status RECRUITING

CH de Mulhouse

Mulhouse, , France

Site Status RECRUITING

CHU de Nantes - Hôtel Dieu

Nantes, , France

Site Status RECRUITING

CHU de Nîmes

Nîmes, , France

Site Status RECRUITING

CHR d'Orléans

Orléans, , France

Site Status RECRUITING

APHP - Hopital Necker

Paris, , France

Site Status RECRUITING

APHP - Hôpital de la Pitié Salpétrière

Paris, , France

Site Status RECRUITING

APHP - Hôpital Saint Antoine

Paris, , France

Site Status RECRUITING

APHP - Hôpital Saint Louis

Paris, , France

Site Status RECRUITING

CH de Perpignan

Perpignan, , France

Site Status RECRUITING

CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie

Pessac, , France

Site Status RECRUITING

CH de Périgueux

Périgueux, , France

Site Status RECRUITING

Centre Hospitalier Lyon Sud

Pierre-Bénite, , France

Site Status RECRUITING

CHU de Poitiers - Hôpital de La Milétrie

Poitiers, , France

Site Status RECRUITING

Centre Hospitalier Annecy Genevois

Pringy, , France

Site Status RECRUITING

CHU de Reims

Reims, , France

Site Status RECRUITING

CHU de Rennes - Hôpital de Pontchaillou

Rennes, , France

Site Status RECRUITING

Centre Henri Becquerel

Rouen, , France

Site Status RECRUITING

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

Saint-Etienne, , France

Site Status RECRUITING

Institut de Cancerologie Strasbourg Europe

Strasbourg, , France

Site Status RECRUITING

Institut Universitaire du Cancer de Toulouse - Oncopole

Toulouse, , France

Site Status RECRUITING

CH de Bretagne Atlantique - Hopital Chubert

Vannes, , France

Site Status RECRUITING

Charite Universitat Smedizin Berlin

Berlin, , Germany

Site Status RECRUITING

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

Goettigen, , Germany

Site Status RECRUITING

Universitatsklinikum Halle (Saale)

Halle, , Germany

Site Status RECRUITING

UNIVERSITAT LEIPZIG - Klinik fur Hamatologie, Zelltherapie und Hamostaseo

Leipzig, , Germany

Site Status RECRUITING

UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III

Regensburg, , Germany

Site Status RECRUITING

Hospital Universitari Vall d'Hebron

Barcelona, , Spain

Site Status NOT_YET_RECRUITING

Hospital Universitario Fundacion Jimenez Diaz - Hematologia

Madrid, , Spain

Site Status RECRUITING

Hospital Universitario Marqués de Valdecilla

Santander, , Spain

Site Status NOT_YET_RECRUITING

Hospital Clínico Universitario de Valencia

Valencia, , Spain

Site Status NOT_YET_RECRUITING

Countries

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Belgium France Germany Spain

Central Contacts

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Baptiste LAVERROUX

Role: CONTACT

[email protected]
+33 4 27 01 27 18

Facility Contacts

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Alice WOLFROMM, MD

Role: primary

Karolien BEEL, MD

Role: primary

Sylvia SNAUWAERT, MD

Role: primary

Sarah BAILLY, MD

Role: primary

Delphine PRANGER, MD

Role: primary

Matthias VANDERKERKEN, MD

Role: primary

Marie-Christine NGIRABACU, MD

Role: primary

Claire MAQUET, MD

Role: primary

Renaud FOUFOSSE, MD

Role: primary

Selim SID, MD

Role: primary

Marc ANDRE, MD

Role: primary

Pierre FEUGIER, MD

Role: primary

Pierre MOREL, MD

Role: primary

Aline CLAVERT, MD

Role: primary

Borhane SLAMA, MD

Role: primary

Sophie BERNARD, MD

Role: primary

Fontanet BIJOU, Pr

Role: primary

Ghandi DAMAJ, MD

Role: primary

Arthur DONY, Dr

Role: primary

Olivier TOURNILHAC, MD

Role: primary

François LEMONNIER, MD

Role: primary

Steeve Chevreux, MD

Role: primary

Sarah BARBIEUX, Dr

Role: primary

Stéphane VIGOUROUX, MD

Role: primary

Sylvain CARRAS, MD

Role: primary

Hassan FARHAT, MD

Role: primary

Kamel LARIBI, MD

Role: primary

Franck MORSCHHAUSER, Pr

Role: primary

Sandy AMORIM, MD

Role: primary

Julie ABRAHAM, MD

Role: primary

Yann GUILLERMIN, MD

Role: primary

Wajed ABARAH - ATASI, MD

Role: primary

Charles HERBAUX, MD

Role: primary

Mathilde LAMARQUE, MD

Role: primary

Thomas GASTINNE, MD

Role: primary

Agathe WAULTIER RASCALOU, MD

Role: primary

Marlène OCHMANN, MD

Role: primary

Morgane Cheminant, MD

Role: primary

Adrien GRENIER, MD

Role: primary

Laure Ricard, MD

Role: primary

Catherine THIEBLEMONT, Pr

Role: primary

Sara BURCHERI, MD

Role: primary

Kamal BOUABDALLAH, MD

Role: primary

Claire CALMETTES, MD

Role: primary

Emmanuel BACHY, Pr

Role: primary

Stéphanie GUIDEZ, MD

Role: primary

Nicolas Daguindau, MD

Role: primary

Eric DUROT, MD

Role: primary

Roch HOUOT, Pr

Role: primary

Olivier CAMUS, MD

Role: primary

Ludovic FOUILLET, MD

Role: primary

Luc FORNECKER, Pr

Role: primary

Loïc YSEBAERT, MD

Role: primary

Antoine BONNET, MD

Role: primary

Gerald Wulf

Role: primary

Francesc BOSCH, MD

Role: primary

Raul CORDOBA, MD

Role: primary

Lucrecia YANEZ, MD

Role: primary

M José TEROL, MD

Role: primary

References

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Cheminant M, Lhermitte L, Bruneau J, Sicard H, Bonnafous C, Touzart A, Bourbon E, Ortonne N, Genestier L, Gaulard P, Palmic P, Suarez F, Frenzel L, Naveau L, Bazarbachi A, Dussiot M, Waast L, Avettand-Fenoel V, Brouzes C, Pique C, Lepelletier Y, Asnafi V, Marcais A, Hermine O. KIR3DL2 contributes to the typing of acute adult T-cell leukemia and is a potential therapeutic target. Blood. 2022 Sep 29;140(13):1522-1532. doi: 10.1182/blood.2022016765.

Reference Type DERIVED
PMID: 35687761 (View on PubMed)

Other Identifiers

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KILT

Identifier Type: -

Identifier Source: org_study_id

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