New Antibody (Lacutamab) for the Treatment of T-Cell Lymphomas

Peripheral T-cell lymphoma (PTCL) refers to a group of aggressive non-Hodgkin lymphomas that arise from the malignant transformation of so-called T cells. T cells are a type of white blood cell that play a role in the immune system. These lymphomas are rare and often have a poorer prognosis than other types of lymphoma. Standard treatment involves intensive therapies, usually based on chemotherapy. In 30% of cases, initial treatment is insufficient (refractory) or patients experience a relapse. For these patients, the KILT study is investigating the additional benefit of lacutamab, a new antibody that binds to the KIR3DL2 protein, which is frequently found on the surface of T cells in PTCL. By binding to KIR3DL2, Lacutamab can activate the immune system to destroy the cancer cells.

The goal of the KILT study is to evaluate Lacutamab in PTCL. To this end, the study compares two groups of patients: One group receives Lacutamab in combination with GemOx chemotherapy (a standard combination of gemcitabine and oxaliplatin), while the other group receives GemOx alone. GemOx is an established chemotherapy regimen for PTCL in cases of refractory or relapsed disease. In the first group, patients receive Lacutamab plus GemOx for 6 cycles of 3 weeks each, followed by an additional 20 cycles of a maintenance dose of Lacutamab, each lasting 4 weeks. The control group (Group 2) receives the established GemOx therapy for 6 cycles of 3 weeks each. Patients are randomly assigned in a 2:1 ratio to either the lacutamab-GemOx group or the GemOx group. The study is designed as a Phase 2 trial and will be conducted as an open-label study (all participants know their assignment). The primary objectives of the study are to evaluate progression-free survival (PFS), that is, how long patients live without disease progression. In addition, the safety and tolerability of the therapy will be investigated. Other objectives include overall survival (OS) and the complete response rate (CRR) to the therapy. To this end, patients will be monitored regularly for 5 ½ years after the start of the study.

Eligible participants include women and men aged 18 and older with histologically confirmed PTCL who have received at least one prior course of systemic chemotherapy. At least 1% of the tumor cells must express the KIR3DL2 protein (KIR3DL2-positive).