Nova Lima

This research investigates the effectiveness 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 previously treated with lenalidomide. The study is a Phase 3, randomized, open-label trial conducted at multiple centers. It aims to provide new options for patients whose disease has returned or did not respond after prior therapies. Participants will receive either arlo-cel or one of several standard regimens that include drugs such as cyclophosphamide, fludarabine, daratumumab, pomalidomide, dexamethasone, or carfilzomib. Each medication is given in specified doses on designated days as part of the treatment plan. The study compares these approaches to assess which is more effective in managing the disease. Throughout the study, researchers will monitor participants for progression-free survival up to five years after the last participant is enrolled and the presence of minimal residual disease negativity within one year. Participants will undergo assessments to measure disease status, organ function, and performance status. Safety and treatment effects will be tracked during the study period to understand the impact of the therapies over time.

Researchers are evaluating several repurposed therapies including Fluvoxamine plus Budesonide, Fluoxetine plus Budesonide, and Spirulin Platensis to treat patients with early-onset COVID-19 who have mild symptoms but are at high risk for complications. This phase 3, double-blind, randomized, placebo-controlled study aims to assess if these treatments can reduce emergency care visits, hospitalizations, and oxygen desaturation events related to COVID-19 progression. The study builds on observational and experimental evidence suggesting these agents may have anti-inflammatory effects beneficial in early SARS-CoV-2 infection. Participants receive one of the study treatments or placebo following specific dosing schedules: Spirulin Platensis is given as two tablets every 12 hours for 10 days; Fluvoxamine plus Budesonide involves Fluvoxamine tablets every 12 hours and Budesonide inhalation every 12 hours for 10 days; Fluoxetine plus Budesonide is administered as Fluoxetine tablets daily plus Budesonide inhalation every 12 hours for 7 days. Placebo groups receive matching oral and inhalation placebos or paracetamol as an active comparator. The study includes adaptive modifications such as the addition of new treatment arms and changes to primary endpoints. During the 28-day follow-up, participants are monitored for emergency visits due to worsening COVID-19, hospitalizations related to disease progression, and oxygen saturation levels. Researchers evaluate safety and treatment effects through clinical assessments, laboratory tests, and symptom tracking. Participants must consent to treatment and follow study procedures, with ongoing monitoring for adverse events and protocol adherence throughout the study period.

Researchers are evaluating the safety and effectiveness of TARA-002, given directly into the bladder, in adults aged 18 years or older with high-grade non-muscle invasive bladder cancer, including carcinoma in situ (CIS) with or without Ta/T1. This Phase 2, open-label study focuses on participants who have active disease confirmed at their last tumor evaluation, enrolling them into two groups based on their prior exposure to BCG treatment. All participants receive six weekly doses of TARA-002 at a dose established in a previous Phase 1 study during the first treatment period. Those eligible for reinduction receive six more weekly doses in the second treatment period. Participants who achieve a complete response after the first treatment receive three additional weekly doses as maintenance during the second period. A third treatment period provides all eligible participants with three weekly doses at months 6, 9, 12, 15, and 18. Following treatment, participants enter a follow-up phase lasting from month 21 to month 60. During the study, researchers assess the occurrence of a high-grade complete response at any time from month 3 to month 60, including subgroup analyses for certain cohorts. Participants undergo pathology reviews to confirm response. The study monitors safety and efficacy throughout treatment and long-term follow-up, with evaluations designed to capture the duration and quality of the treatment response over several years.

Researchers are evaluating whether patients with ventilator-associated tracheobronchitis (VAT) in intensive care units benefit from a 7-day course of antibiotics compared to clinical observation without antibiotic treatment. This trial is a national, multicenter, single-blinded, randomized non-inferiority study aiming to determine if monitoring without antibiotics is as effective as antibiotic therapy for VAT, given the current uncertainty and conflicting guidelines about antibiotic use for this condition. Participants diagnosed with VAT will be randomly assigned to one of two groups. One group will receive standard care plus a 7-day antibiotic course, while the other group will have clinical observation without antibiotics unless they develop new organ dysfunction or infections other than VAT. The study focuses on comparing these two approaches to see if withholding antibiotics is noninferior in managing VAT. During the study, patients will be monitored for ventilator-free days within 28 days after randomization. Researchers will assess clinical status, chest imaging, and tracheal secretion cultures. Safety and treatment effects will be carefully tracked, with data analysis conducted in a blinded manner. The trial encompasses ICU patients who have been mechanically ventilated for at least 48 hours and meet specific clinical and laboratory criteria for VAT.