Phase I Study Evaluating Safety and Effectiveness of Methylene Blue for Treating Cytokine Release Syndrome and ICANS After CAR-T or Bispecific Antibody Therapy

What this Trial Is About

Researchers are studying the use of methylene blue MB as an additional treatment for patients who develop cytokine release syndrome CRS or immune effector cell-associated neurotoxicity syndrome ICANS after receiving CAR-T cell therapy or bispecific antibody treatments. This Phase I, single-arm clinical trial aims to assess the safety and potential benefits of MB in reducing these immune-related side effects while maintaining the cancer-fighting effects of the immune cells. Participants will receive intravenous infusions of methylene blue once daily for 3 to 5 consecutive days. The study uses a dose-escalation design with three groups receiving different doses 1 mgkg, 2 mgkg, or 3 mgkg, each infused over 20 minutes. Alongside MB treatment, patients may also receive standard supportive care such as tocilizumab, dexamethasone, ruxolitinib, or cetuximab if needed. During the trial, participants will be closely monitored for vital signs like temperature, blood pressure, and oxygen levels, as well as laboratory tests including inflammatory markers and neurotoxicity assessments. The main measurements focus on any serious side effects related to MB, its impact on immune cell expansion and therapy effectiveness, and the frequency and duration of CRS and ICANS symptoms. The study lasts up to 35 days after starting MB treatment to observe safety and outcomes.

Adjunctive Methylene Blue for Immunotherapy-related CRS and ICANS: Phase I Study