Actively Recruiting
Study of Lacutamab in Peripheral T-cell Lymphoma
Led by The Lymphoma Academic Research Organisation · Updated on 2026-04-20
56
Participants Needed
64
Research Sites
342 weeks
Total Duration
On this page
Sponsors
T
The Lymphoma Academic Research Organisation
Lead Sponsor
I
Innate Pharma
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
Study of Lacutamab in Peripheral T-cell Lymphoma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- KIR3DL2-positive with at least 1% tumor cell positivity by immunohistochemistry before randomization
- Histologically documented PTCL including PTCL-NOS, PTCL-TFH (AITL, Follicular, Nodal TFH), ALCL, ATL (acute or lymphoma type), HSTL, EATL, MEITL, NKT, ANKL
- For ALCL patients: previously treated with brentuximab vedotin
- Relapsed or refractory PTCL after at least one prior systemic chemotherapy regimen
- Maximum of 2 prior systemic therapy lines including autologous stem cell transplantation (ASCT not counted as separate line)
- Measurable disease with at least one lesion 21.5 cm by CT scan
- Signed written informed consent for screening and study participation
- Age 18 years or older at randomization
- ECOG performance status 0 to 3 before prephase treatment and 0 to 2 before randomization
- Minimum life expectancy of 3 months
- Females of childbearing potential must agree to use highly effective contraception during the study and for 9 months after last treatment
- Negative pregnancy test within 28 days prior to first treatment for females of childbearing potential
- Male patients and partners must agree to use two reliable contraception methods during the study and for 9 months after last treatment
You will not qualify if you...
- Active COVID-19 infection within 2 weeks before randomization
- Receiving immunotherapy or chemotherapy except short-term corticosteroids within 3 weeks prior to first treatment
- Previous treatment with Gemcitabine or Oxaliplatin
- Use of experimental anti-cancer drugs within 6 weeks before randomization
- Contraindications to study drugs
- Previous allogenic hematopoietic cell transplantation
- Positive HIV or Hepatitis C virus test (HCV antibody positive patients must be PCR negative)
- Active hepatitis B infection (positive HBs antigen); latent HBV must be treated and monitored monthly
- Central nervous system or meningeal lymphoma involvement
- Lab abnormalities: ANC <1 G/L unless related to PTCL, Platelets <75 G/L unless related to PTCL, ALP >2.5x ULN, AST/ALT >2.5x ULN, Bilirubin >1.5x ULN unless related to PTCL or hemolysis, Creatinine clearance <40 mL/min
- Significant cardiovascular disease including NYHA Class III/IV, uncontrolled hypertension, recent heart attack or stroke, or recent arrhythmia
- Uncontrolled serious illness such as diabetes or ongoing infections
- Concurrent or recent other malignancies unless disease-free for at least 2 years except certain skin or localized cancers
- Major surgery within 4 weeks before randomization
- Pregnant or breastfeeding females
AI-Screening
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Trial Site Locations
Total: 64 locations
1
Institut Jules Bordet
Anderlecht, Belgium
Actively Recruiting
2
VZW ZAS
Antwerp, Belgium
Actively Recruiting
3
A. Z. Sint-Jan
Bruges, Belgium
Actively Recruiting
4
Cliniques Universitaires de Bruxelles - Hôpital Erasme
Brussels, Belgium
Suspended
5
Cliniques universitaires Saint-Luc - Université catholique de Louvain
Brussels, Belgium
Actively Recruiting
6
Grand Hôpital de Charleroi
Charleroi, Belgium
Actively Recruiting
7
UZ Antwerpen
Edegem, Belgium
Actively Recruiting
8
HELORA - Hôpital de La LouvièreSite Jolimont
Haine-Saint-Paul, Belgium
Actively Recruiting
9
CHU de LIEGE - Domaine Sart Tilman
Liège, Belgium
Actively Recruiting
10
Clinique CHC MontLégia
Liège, Belgium
Actively Recruiting
11
CHR Verviers
Verviers, Belgium
Actively Recruiting
12
CHU Dinant Godinne - UCL Namur - YVOIR
Yvoir, Belgium
Actively Recruiting
13
CHU de Nancy - Brabois
Nancy, France, France
Actively Recruiting
14
CHU d'Amiens
Amiens, France
Actively Recruiting
15
CHU d'Angers
Angers, France
Actively Recruiting
16
CH d Avignon - Hopital Henri Duffaut
Avignon, France
Actively Recruiting
17
CH de la Côte Basque - Hôpital de Bayonne
Bayonne, France
Actively Recruiting
18
Institut Bergonié
Bordeaux, France
Actively Recruiting
19
CHU de Caen - Côte de Nacre - IHBN
Caen, France
Actively Recruiting
20
CH Métropole Savoie
Chambéry, France
Actively Recruiting
21
CHU de Clermont Ferrand - Estaing
Clermont-Ferrand, France
Actively Recruiting
22
APHP - Hôpital Henri Mondor
Créteil, France
Actively Recruiting
23
CHU de Dijon BOURGOGNE - Hôpital François Mitterand
Dijon, France
Actively Recruiting
24
CH de Dunkerque
Dunkirk, France
Actively Recruiting
25
CHD de Vendée
La Roche-sur-Yon, France
Actively Recruiting
26
CHU de Grenoble - Hôpital Albert Michallon
La Tronche, France
Actively Recruiting
27
Ch de Versailles - Hopital Andre Mignot
Le Chesnay, France
Actively Recruiting
28
CH du Mans
Le Mans, France, 72000
Actively Recruiting
29
CHRU de Lille - Hôpital Claude Hurriez
Lille, France
Actively Recruiting
30
Hôpital Saint Vincent-De-Paul
Lille, France
Actively Recruiting
31
Chu de Limoges - Hopital Dupuytren
Limoges, France
Actively Recruiting
32
Centre Leon Berard
Lyon, France, 69373
Actively Recruiting
33
Chu de Meaux
Meaux, France
Actively Recruiting
34
CHU de Montpellier
Montpellier, France
Actively Recruiting
35
CH de Mulhouse
Mulhouse, France
Actively Recruiting
36
CHU de Nantes - Hôtel Dieu
Nantes, France
Actively Recruiting
37
CHU de Nîmes
Nîmes, France
Actively Recruiting
38
CHR d'Orléans
Orléans, France
Actively Recruiting
39
APHP - Hopital Necker
Paris, France
Actively Recruiting
40
APHP - Hôpital de la Pitié Salpétrière
Paris, France
Actively Recruiting
41
APHP - Hôpital Saint Antoine
Paris, France
Actively Recruiting
42
APHP - Hôpital Saint Louis
Paris, France
Actively Recruiting
43
CH de Perpignan
Perpignan, France
Actively Recruiting
44
CHU de Bordeaux - Hôpital Haut Lévêque - Centre François Magendie
Pessac, France
Actively Recruiting
45
CH de Périgueux
Périgueux, France
Actively Recruiting
46
Centre Hospitalier Lyon Sud
Pierre-Bénite, France
Actively Recruiting
47
CHU de Poitiers - Hôpital de La Milétrie
Poitiers, France
Actively Recruiting
48
Centre Hospitalier Annecy Genevois
Pringy, France
Actively Recruiting
49
CHU de Reims
Reims, France
Actively Recruiting
50
CHU de Rennes - Hôpital de Pontchaillou
Rennes, France
Actively Recruiting
51
Centre Henri Becquerel
Rouen, France
Actively Recruiting
52
Institut de Cancérologie et d'Hématologie Universitaire de Saint-Étienne
Saint-Etienne, France
Actively Recruiting
53
Institut de Cancerologie Strasbourg Europe
Strasbourg, France
Actively Recruiting
54
Institut Universitaire du Cancer de Toulouse - Oncopole
Toulouse, France, 31100
Actively Recruiting
55
CH de Bretagne Atlantique - Hopital Chubert
Vannes, France
Actively Recruiting
56
Charite Universitat Smedizin Berlin
Berlin, Germany
Actively Recruiting
57
GEORG-AUGUST-UNIV, GOETTINGEN - Klinik fur Haematologie und Medizini
Goettigen, Germany
Actively Recruiting
58
Universitatsklinikum Halle (Saale)
Halle, Germany
Actively Recruiting
59
UNIVERSITAT LEIPZIG - Klinik fur Hamatologie, Zelltherapie und Hamostaseo
Leipzig, Germany
Actively Recruiting
60
UNIVERSITATSKLINIKUM REGENSBURG - Klinik für Innere Medizin III
Regensburg, Germany
Actively Recruiting
61
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Not Yet Recruiting
62
Hospital Universitario Fundacion Jimenez Diaz - Hematologia
Madrid, Spain
Actively Recruiting
63
Hospital Universitario Marqués de Valdecilla
Santander, Spain
Not Yet Recruiting
64
Hospital Clínico Universitario de Valencia
Valencia, Spain
Not Yet Recruiting
Research Team
B
Baptiste LAVERROUX
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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