Gandhinagar

Researchers are investigating the use of lisaftoclax combined with BTK inhibitors in patients with chronic lymphocytic leukemia or small lymphocytic lymphoma CLLSLL who have previously been treated with BTK inhibitors. This global, open-label, phase III study aims to evaluate the effectiveness and safety of this combination compared to BTK inhibitor alone in patients who have been on BTK inhibitor monotherapy for at least 12 months. About 440 participants will be randomly assigned to one of two groups one will receive lisaftoclax together with a BTK inhibitor, and the other will receive only a BTK inhibitor. The study uses a parallel design where participants are allocated equally to each treatment arm to compare outcomes clearly. Both treatments are administered under medical supervision, and the study is open-label, meaning both the researchers and participants know which treatment is given. Participants will be assessed regularly over the course of the study, with evaluations including disease progression measured at 12 months and overall survival also tracked at 12 months. Eligibility screening includes assessments of performance status, bone marrow, kidney, and liver function, as well as consent to follow the study schedule. The research team monitors safety and treatment effects throughout the trial, which is expected to complete by late 2027.

Researchers are evaluating ISB 2001 in adults with relapsed or refractory multiple myeloma RR MM who have already been treated with immunomodulatory drugs, proteasome inhibitors, and anti-CD38 therapies but remain resistant or intolerant to these treatments. This first-in-human, Phase 1, open-label study aims to assess the safety and anti-myeloma activity of ISB 2001. The study is sponsored by Ichnos Sciences SA and involves participants who have measurable disease and adequate organ function. The study has two parts dose escalation and dose expansion. In the dose escalation phase, participants receive increasing doses of ISB 2001 to determine the maximum safe dose. In the dose expansion phase, participants receive ISB 2001 at the optimal dose identified to further confirm safety and biological activity. ISB 2001 is given weekly on Days 1, 8, 15, and 22 of each 28-day cycle, with an additional step-up dose on Day 4 of Cycle 1. Treatment continues until disease progression, unacceptable side effects, or withdrawal. Participants will undergo regular monitoring for treatment-emergent adverse events and dose-limiting toxicities during the first cycle, with follow-up visits extending up to 18 months. Researchers will measure drug levels in the blood, immune responses to the drug, and multiple clinical outcomes related to disease response and progression. Ongoing assessments will include physical exams, performance status, and laboratory tests to track safety and treatment effects throughout the study period.