Gandhinagar

Researchers are investigating ISB 2001 in adults with relapsed or refractory multiple myeloma (R/R MM) who have previously been treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapies but did not respond or could not tolerate these treatments. This first-in-human, open-label Phase 1 study aims to assess the safety and anti-myeloma activity of ISB 2001, focusing on finding the optimal dose and monitoring adverse effects. The study is divided into two parts: dose escalation and dose expansion. During dose escalation, participants receive increasing doses of ISB 2001 to identify the maximum planned dose. In the dose expansion phase, participants receive injections of ISB 2001 at the determined optimal dose. Treatment continues until the disease progresses, unacceptable side effects occur, stopping criteria are met, or participants decide to withdraw. Throughout the study, researchers monitor treatment-emergent adverse events and dose-limiting toxicities to evaluate safety over up to 18 months. Participants undergo assessments of their disease status, organ functions, and overall health. Safety monitoring includes laboratory tests and clinical evaluations, with follow-up to understand the treatment's impact and tolerability over time.