Zeytinburnu

Researchers are evaluating the effect of a triple therapy inhaler called BGF MDI containing budesonide, glycopyrronium, and formoterol fumarate compared with a dual therapy inhaler called GFF MDI containing glycopyrronium and formoterol fumarate in people with Chronic Obstructive Pulmonary Disease (COPD) who have a higher risk of heart and lung problems. This Phase III randomized, double-blind, parallel group study takes place at multiple centers and focuses on cardiopulmonary outcomes in these patients. Participants receive either the BGF MDI 320/14.4/9.6 micrograms twice daily or the GFF MDI 14.4/9.6 micrograms twice daily. The treatments are inhaled using metered dose inhalers. The study compares these two therapies over time to see how they affect the time until the first severe heart or lung event occurs. The study design ensures that neither participants nor researchers know which treatment is given to reduce bias. During the study, participants will have regular visits to the study site or virtual visits to complete assessments. Researchers will monitor lung function, symptoms, and blood tests, including blood eosinophil counts and COPD assessment test scores. The main outcome measured is the time to the first severe cardiac or COPD event, with follow-up lasting up to three years. Safety and adherence to treatment will also be closely observed throughout the study period.

Researchers are studying AZD0292, a bispecific antibody, to see if it can prevent flare-ups in people aged 12 and older who have bronchiectasis with chronic colonization by Pseudomonas aeruginosa (PsA). This Phase IIb trial compares two different doses of AZD0292 given through intravenous infusion against a placebo. The study mainly focuses on non-cystic fibrosis bronchiectasis patients with frequent PsA-related lung exacerbations, which can worsen lung function, quality of life, and survival. Cystic fibrosis bronchiectasis patients colonized with PsA are also included as an exploratory group. Participants will receive either a high or low dose of AZD0292 or a placebo starting on Day 1 by IV infusion, with additional doses given according to the study schedule. The trial is randomized, double-blind, placebo-controlled, and parallel in design. Treatment effects, safety, and how the body processes the drug will be studied over the course of dosing. During the study, participants will be monitored for lung exacerbations over a follow-up period ranging from 28 to 52 weeks. Researchers will assess lung function, collect airway samples to confirm PsA colonization, and track any side effects or adverse events. The main measure of success is the annualized rate of exacerbations. Participants must adhere to study visits and assessments throughout the trial to help determine the drug’s effectiveness and safety.

Researchers are evaluating the safety and effectiveness of MB-CART2019.1, a genetic therapy, compared to standard treatments in adults with relapsed or refractory diffuse large B-cell lymphoma (DLBCL) who cannot undergo high-dose chemotherapy and stem cell transplantation. The study is divided into two parts: Part I compares MB-CART2019.1 to standard care in a randomized, open-label Phase II trial, while Part II assesses MB-CART2019.1 alone in younger, fitter patients with the same condition. In Part I, participants are randomly assigned to receive either a single infusion of MB-CART2019.1—a therapy made from the patient's own modified T cells after leukapheresis and lymphodepleting chemotherapy—or standard care treatments including R-GemOx or BR plus polatuzumab vedotin. Part II will enroll about 45 participants to further evaluate MB-CART2019.1 in a single-arm study. The study includes screening up to 4 weeks before leukapheresis, with treatment and follow-up periods extending up to one year after therapy administration. Participants will undergo multiple assessments including imaging scans and tissue analyses to measure tumor response and safety. Researchers will monitor event-free survival up to 30 weeks after randomization and best objective response rate up to 30 weeks after MB-CART2019.1 administration. Follow-up continues for one year post-treatment with additional long-term follow-up reported separately. The study requires participants to meet specific health and diagnostic criteria and to comply with study procedures throughout the trial.

Researchers are evaluating the safety and preliminary effectiveness of pumitamig, an investigational drug, combined with standard chemotherapy in adults with advanced or metastatic Non-small Cell Lung Cancer (NSCLC) that has progressed after first-line chemoimmunotherapy. This Phase II, open-label study involves two parts: a safety run-in phase to determine the tolerable dose of pumitamig with docetaxel, followed by a dose expansion phase to further assess treatment at the selected dose. In Part 1, up to 12 participants will receive pumitamig (at one of two dose levels) plus docetaxel sequentially to evaluate safety. If the dose is deemed tolerable, Part 2 will enroll up to 54 participants to receive pumitamig combined with docetaxel at the safe dose. Participants in Part 2 may also be asked to provide tumor biopsy samples before and during treatment for additional analysis. Treatment will continue until disease progression, intolerable side effects, withdrawal, death, study end, or up to 2 years. During the study, participants will be closely monitored for side effects, including serious and treatment-related events, dose adjustments, and overall response to treatment for up to two years. After treatment ends, a long-term follow-up will track disease progression, new treatments, and survival. Safety assessments include monitoring dose-limiting toxicities within 21 days of the first dose and adverse events through a 90-day follow-up period.

Researchers are evaluating the safety, effectiveness, and pharmacokinetics of pumitamig (BNT327) combined with chemotherapy and other investigational agents in adults with first-line non-small cell lung cancer (NSCLC). The study includes two substudies based on NSCLC histological subtypes due to differences in chemotherapy treatments. This Phase 2/3, multisite, randomized, open-label trial aims to assess treatments in participants with advanced NSCLC who have not previously received systemic treatment. Each substudy has a Phase 2 part where participants are randomly assigned to one of two doses of pumitamig combined with chemotherapy drugs such as pembrolizumab, carboplatin, pemetrexed, or paclitaxel, given intravenously. The Phase 3 part will include independent data monitoring and blinded central review of tumor scans for all treated participants. The overall planned duration per participant is up to 64 months, covering both study parts and follow-up. Participants will undergo regular tumor assessments and monitoring for safety, including recording treatment-emergent adverse events, dose changes, and serious side effects up to 90 days after the last dose. Effectiveness will be measured by tumor response rates, changes in tumor size, and progression-free survival, with tumor imaging reviewed by a blinded independent committee. This long-term study involves careful evaluation of treatment impact and participant health over approximately five years.