Norway-based biotechnology company Nordic Nanovector has enrolled its first patient in arm three of expanded Phase l/ll study, Lymrit 37-01, of betalutin to treat non-Hodgkin’s lymphoma (NHL).
Betalutin is a new anti-CD37 that aims antibody radionuclide conjugate in development for the treatment of major types of NHL, including follicular lymphoma (FL).
The arm three of the trial is designed to investigate the safety and efficacy of Betalutin in up to 12 patients with relapsed FL pre-dosed and standard anti-CD20 immunotherapy (rituximab) on day 0, a few hours prior to the administration of Betalutin.
The Lymrit 37-01 study is a Phase l/ll open label, single injection, ascending dose study that is investigating three dose levels of Betalutin and different dosing regimens in patients with relapsed NHL.
Lymrit 37-01 aims to identify an optimal dose regimen to take into the Phase ll Paradigme study, expected to start next year.
Nordic Nanovector noted that patient recruitment into the Phase ll part of arm one is going on with dose-escalation expected to begin in the second quarter of this year.
Patient screening is also going on for the final arm in the expanded Lymrit 37-01 study (arm four), in which escalating doses of Betalutin plus pre-treatment with a higher dose of cold anti-CD37 antibody than in arm one will be evaluated in relapsed FL patients.
The company is expecting to make a decision to increase the dose of Betalutin to 17.5 MBq/kg in arm one, on the basis of the evaluation of the safety and efficacy data observed in the 15 patients treated with 15 MBq/kg in Phase ll part of arm one.
In addition, decision to increase the dose of Betalutin to 17.5 MBq/kg or 20 MBq/kg in one or the other of arms three and four can be made based on the evaluation of the safety and efficacy data observed in the first three patients of both cohorts.