Early Phase Study to Evaluate Safety and Activity of OT-C001 Natural Killer Cell Therapy in Adults with Relapsed or Refractory Diffuse Large B-Cell Lymphoma

What this Trial Is About

Researchers are studying the safety and appropriate dosing of OT-C001, a type of amplified and activated allogenic natural killer cells, in patients with relapsed or refractory diffuse large B-cell lymphoma who have limited treatment options. This early-phase clinical trial also aims to observe the preliminary activity of OT-C001 in fighting this form of lymphoma. The study is led by Emercell SAS and focuses on patients with evaluable disease and adequate biological conditions. Participants will first receive a short course of chemotherapy before starting OT-C001 treatment. During the treatment phase, they will receive weekly intravenous infusions of OT-C001 for either 3 or 6 weeks, depending on their assigned dose group. Additionally, participants will be given two supporting drugs, rituximab and interleukin-2, as part of the treatment plan. There are different dosing levels being tested, including one vial, three vials, or a sub-dose of OT-C001. Throughout the study, participants will visit the clinic regularly and may need hospitalization based on the study plan. Researchers will monitor safety by assessing adverse events, lab tests, vital signs, ECGs, and physical exams from the start of treatment until shortly after the last dose. They will also evaluate antitumor activity using imaging criteria at the end of treatment cycles and follow participants every 12 weeks for up to two years to track disease progression or new cancer treatments.

A First-in-human Study to Assess OT-C001 (Amplified/Activated Allogenic Natural Killer Cells) in Patients With Relapsed/Refractory Diffuse Large B Cell Lymphoma