Abstract 647TiP
Background
Peripheral T-cell Lymphoma (PTCL) is a heterogeneous group of mature T-cell lymphomas with adverse outcomes. The majority of patients (pts) with PTCL relapse despite responding to first line systemic therapy. Current treatment options for relapsing PTCL are limited with no generally accepted standard of care to treat these pts. KIR3DL2 is a killer immunoglobulin-like receptor that is expressed across different subtypes of T-cell lymphomas including PTCL. Approximately 40% of PTCL pts expresses KIR3DL2. Lacutamab is a humanized first-in-class monoclonal antibody designed to deplete KIR3DL2-expressing cells via antibody-dependent cell-cytotoxicity and phagocytosis. In a previous phase I trial in pts with relapsed/refractory cutaneous T-cell lymphoma (CTCL), lacutamab showed adequate safety profile with no dose limiting toxicities and a global response rate of 42.9% in pts with Sezary Syndrome, with a median time to response of 4.9 months. TELLOMAK open-label, multi-cohort, international phase II trial (NCT03902184) in pts with Advanced T-cell lymphoma is ongoing.
Trial design
This is a multi-center, open-label, phase Ib trial (NCT05321147). Eligible patients may have any subtype of relapsed / refractory PTCL and must have received at least one prior line of systemic therapy. All patients should have a KIR3DL2 expression ≥ 1%. Lacutamab 750 mg is administered as an intravenous infusion weekly x 5 weeks (w), every 2 w x 10 then every 4 w, until progression or unacceptable toxicity. Up to 40 patients are planned to be enrolled. Approximately 20 patients will be initially included. Depending on safety profile and preliminary level of clinical activity (at least 3 responses), 20 more patients could be added. The primary objective is to assess the safety and tolerability of lacutamab. Secondary objectives are to assess the clinical activity and to characterize the pharmacokinetics, and immunogenicity of lacutamab. The trial is currently enrolling in 11 medical centers in the US and South Korea.
Clinical trial identification
Editorial acknowledgement
Legal entity responsible for the study
Innate Pharma, S.A.
Funding
Innate Pharma, S.A.
Disclosure
S.P. Iyer: Financial Interests, Institutional, Invited Speaker: Innate, Seagen, CRISPRX, Rhizen, Merck, AstraZeneca, Legend, Acrotech. I.B. Greenwell: Financial Interests, Personal, Advisory Board: Stemline, Acrotech Biopharma; Financial Interests, Institutional, Other, Patient program funding: Kyowa Kirin. M. Muller: Financial Interests, Personal, Full or part-time Employment: Innate Pharma, S.A. All other authors have declared no conflicts of interest.