OncoMatch/Clinical Trials/NCT04984837

Study of Lacutamab in Peripheral T-cell Lymphoma

Is NCT04984837 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Lacutamab and Gemcitabine for peripheral t cell lymphoma.

Phase 2RecruitingThe Lymphoma Academic Research OrganisationNCT04984837Data as of May 2026

Treatment: Lacutamab · Gemcitabine · Oxaliplatine — 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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Extracted eligibility criteria

Cancer type

Non-Hodgkin Lymphoma

Biomarker criteria

Required: KIR3DL2 expression ≥1% (≥1% of tumour cells positivity by IHC)

KIR3DL2-positive with at least 1% of tumour cells positivity, before randomization, based on central evaluation by immunohistochemistry (IHC)

Performance status

ECOG 0–2(Ambulatory, capable of self-care)

Prior therapy

Max 2 prior lines

Min 1 prior line

Must have received: systemic chemotherapy

Relapsed/refractory PTCL after at least one previous line of systemic based regimen of chemotherapy

Must have received: brentuximab vedotin (brentuximab vedotin)

For patients with ALCL: previously treated with brentuximab vedotin

Cannot have received: Gemcitabine (Gemcitabine)

Previous treatment by Gemcitabine

Cannot have received: Oxaliplatin (Oxaliplatin)

Previous treatment by Oxaliplatin

Cannot have received: allogenic hematopoietic cell transplantation

Previous allogenic hematopoietic cell transplantation

Cannot have received: experimental anti-cancer drug therapy

Use of any experimental anti-cancer drug therapy within 6 weeks before randomization

Lab requirements

Blood counts

Absolute neutrophil count (ANC) < 1 G/L, unless neutropenia is related to PTCL; Platelet count < 75 G/L, unless thrombopenia is related to PTCL

Kidney function

Calculated creatinine clearance (MDRD or Cockcroft) < 40 mL/min

Liver function

Alkaline Phosphatases > 2.5 x ULN; SGOT/AST or SGPT/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

Cardiac function

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

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 ULN; SGOT/AST or SGPT/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. Any significant cardiovascular impairment: 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

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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