Nova Lima

Researchers are evaluating the efficacy and safety of arlo-cel BMS-986393, a GPRC5D-directed CAR-T cell therapy, compared to standard treatment regimens in adults with relapsed or refractory multiple myeloma who have been exposed to lenalidomide. This Phase 3 study aims to better understand how this new therapy performs in this patient group and may provide important insights into treatment options for this condition. Participants will be randomly assigned to receive either the investigational CAR-T cell therapy arlo-cel or one of the standard treatment regimens, which may include drugs such as Cyclophosphamide, Fludarabine, Daratumumab, Pomalidomide, Dexamethasone, or Carfilzomib. The investigational therapy involves specified doses given on specific days. The study is open-label, multicenter, and will follow participants over time to assess outcomes. During the study, participants will be monitored for progression-free survival and minimal residual disease negativity for up to five years after the last participant is enrolled. Additional outcomes include overall survival, response rates, quality of life changes, and drug concentration levels. Researchers will conduct regular assessments including clinical evaluations and laboratory tests to gather these data. The total participation may last several years to fully capture long-term effects and safety.

Researchers are studying the safety and effectiveness of TARA-002, a biological preparation containing Streptococcus pyogenes cells, for adults aged 18 and older with high-grade non-muscle invasive bladder cancer NMIBC, including carcinoma in situ CIS with or without TaT1 tumors. This Phase 2 open-label trial further evaluates TARA-002 at a dose established in an earlier Phase 1a study. Participants include those with active disease confirmed within 3 months before enrollment, divided into two groups based on prior treatment with BCG therapy. Participants receive TARA-002 directly into the bladder through instillation. The treatment involves an initial period of six weekly doses, followed by a possible second period of six additional weekly doses or three weekly maintenance doses for those with a complete response. Maintenance doses continue at specified months up to 24 months. After treatment, participants enter a follow-up period lasting from month 27 to month 60 to monitor long-term outcomes. Throughout the study, participants undergo regular assessments including evaluations of tumor response, progression-free survival, overall survival, and quality of life using specific questionnaires. Researchers monitor urinary biomarkers and track adverse events from the first day of treatment through the entire follow-up period. The studys main outcome is the rate of high-grade complete response measured from 3 to 60 months after treatment. Total participation may last up to 5 years.