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Evaluating Lacutamab for Peripheral T-cell Lymphoma

A Randomized Non Comparative Phase II Study of Lacutamab With GemOx Versus GemOx Alone in Relapsed/Refractory Patients With Peripheral T-cell Lymphoma

Phase 2 Interventional The Lymphoma Academic Research Organisation · NCT04984837

This study is testing a new drug called Lacutamab to see if it helps people with tough-to-treat Peripheral T-cell Lymphoma feel better when combined with standard chemotherapy.

Quick facts

PhasePhase 2
Study typeInterventional
Enrollment56 (estimated)
Ages18 Years and up
SexAll
SponsorThe Lymphoma Academic Research Organisation Academic / other
Drugs / interventionsbrentuximab, chemotherapy, immunotherapy, cyclophosphamide, prednisone, Lacutamab
Locations64 sites (Anderlecht and 63 other locations)
Trial IDNCT04984837 on ClinicalTrials.gov

What this trial studies

This open-label, multicenter, randomized phase II study aims to assess the safety and efficacy of Lacutamab, a monoclonal anti-KIR3DL2 antibody, in patients with refractory or relapsed KIR3DL2 positive Peripheral T-cell Lymphoma (PTCL). The study includes various subtypes of PTCL and utilizes a non-comparative design with an unbalanced randomization favoring the experimental arm. Participants will receive Lacutamab along with standard chemotherapy agents such as Gemcitabine and Oxaliplatin. The primary goal is to evaluate the treatment's effectiveness in this challenging patient population.

Who should consider this trial

Good fit: Ideal candidates are patients with KIR3DL2-positive PTCL who have experienced relapse or refractory disease after at least one prior line of systemic therapy.

Not a fit: Patients with KIR3DL2-negative tumors or those who have not received prior systemic therapy may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with refractory or relapsed Peripheral T-cell Lymphoma.

How similar studies have performed: While this approach is novel in targeting KIR3DL2 in PTCL, similar studies targeting specific antigens in other lymphomas have shown promising results.

Eligibility criteria

Show full inclusion / exclusion criteria 
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

Where this trial is running

Anderlecht and 63 other locations

+14 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Peripheral T Cell LymphomaRelapse/RecurrenceKIR3DL2PTCLT-cell Lymphoma
Last reviewed 2026-06-09 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.