Sisli

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 studying the effects of Adagrasib alone and combined with pembrolizumab in adults with advanced or metastatic non-small cell lung cancer (NSCLC) who have the KRAS G12C mutation. The Phase 2 part evaluates these treatments in patients who are candidates for first-line therapy, with different groups based on their PD-L1 tumor proportion scores (TPS). The Phase 3 part compares the combination of Adagrasib and pembrolizumab against pembrolizumab alone in patients with NSCLC having PD-L1 TPS of 50% or higher. In Phase 2, there are three patient groups: two with PD-L1 TPS less than 1% randomized to receive either Adagrasib monotherapy or Adagrasib plus pembrolizumab, and one group with PD-L1 TPS of 1% or higher treated with the combination. Adagrasib is given orally at doses of 400 mg twice daily or 600 mg twice daily depending on the group, while pembrolizumab is administered intravenously at 200 mg every three weeks. Phase 3 patients are randomized to receive either Adagrasib 400 mg twice daily plus pembrolizumab 200 mg every three weeks or pembrolizumab alone. Participants will undergo various assessments including brain imaging, tumor measurements, and evaluations of safety and treatment effects over 22 months in Phase 2 and 36 months in Phase 3. Researchers will monitor efficacy, safety, and drug levels, as well as patient-reported outcomes and genetic biomarkers. The study includes patients with untreated or previously treated brain metastases under specific conditions and excludes those with prior systemic treatments for advanced NSCLC or certain brain lesion characteristics.

Multiple myeloma (MM) is a cancer of the blood's plasma cells. The cancer is typically found in the bones and bone marrow (the spongy tissue inside of the bones) and can cause bone pain, fractures, infections, weaker bones, and kidney failure. Treatments are available, but MM can come back (relapsed) or may not get better (refractory) with treatment. This is a study to determine change in disease symptoms of etentamig compared to standard available therapies in adult participants with relapsed/refractory (R/R) MM. Etentamig is an investigational drug being developed for the treatment of R/R MM. This study is broken into 2 Arms; Arm A and Arm B. In Arm A, participants will receive etentamig as a monotherapy. In Arm B, participants will receive the standard available therapy (SAT) identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable. Around 380 adult participants with relapsed/refractory multiple myeloma will be enrolled at approximately 140 sites across the world. In Arm A participants will receive etentamig as an infusion into the vein in 28 day cycles, during the 3.5 year study duration. In Arm B, participants will receive the SAT identified by the Investigator during screening, in accordance with the local (or applicable) approved label, package insert, summary of product characteristics, and/or the institutional guidelines, as applicable, during the 3.5 year study duration. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and questionnaires.

Follicular lymphoma (FL) is the second most common B-cell cancer and the most frequent cancer of lymphocytes, but it is incurable with standard treatments and often returns. This research is a Phase 3 trial evaluating the safety and effectiveness of the investigational drug epcoritamab combined with lenalidomide and rituximab (R2) compared to chemoimmunotherapy in adults who have not been treated for FL before. The study aims to assess adverse events and changes in disease activity among about 1095 participants worldwide. Participants are assigned to one of five treatment groups receiving different therapies. Treatments include R2 alone or combined with subcutaneous epcoritamab injections. Some may receive chemoimmunotherapy options chosen by investigators, including R-CHOP, G-CHOP, R-Benda, or G-Benda, involving various intravenous infusions and oral tablets. Most treatment arms last 120 weeks, except one lasting 24 weeks. The study treatments involve intravenous infusions, oral capsules or tablets, and subcutaneous injections. During the study, participants regularly visit hospitals or clinics for medical assessments, blood tests, side effect monitoring, and questionnaires. Researchers will track responses such as complete response rates at 30 months and progression-free survival up to 10 years. The study also monitors safety and tolerability throughout. Participants’ treatment adherence and disease status will be carefully observed over the study period.

Researchers are evaluating treatments for patients newly diagnosed with Peripheral T-Cell Lymphoma (PTCL). This Phase 3, randomized, open-label study is designed in two parts: the first aims to find the best doses of two drugs, Belinostat and Pralatrexate, combined with CHOP or COP chemotherapy. The second part compares the effectiveness and safety of Belinostat combined with CHOP, Pralatrexate combined with COP, and CHOP alone for up to six treatment cycles. The goal is to determine which treatment best improves progression-free survival over 4.5 years. In Part 1, patients are randomly assigned to one of five groups receiving different doses of Belinostat or Pralatrexate with CHOP or COP, or CHOP alone. Approximately 20 patients per group receive at least one treatment cycle to assess safety and select doses for Part 2. In Part 2, 143 patients per group are randomized 1:1:1 to receive Belinostat-CHOP, Pralatrexate-COP, or CHOP alone. Treatments are given in cycles every 21 days for up to six cycles. Belinostat is given as an intravenous infusion for five days, Pralatrexate as an intravenous push on days 1 and 8, and CHOP or COP chemotherapy on day 1, with prednisone given orally for five days. Participants undergo a 28-day screening period before treatment, followed by up to six cycles of therapy over 18 weeks. Tumor assessments occur every three cycles during treatment and regularly after treatment for up to five years to monitor disease status. Safety and treatment compliance are carefully tracked. Follow-up includes visits at least 30 days after the last dose and phone check-ins every six months for long-term survival monitoring. Researchers measure progression-free survival as the primary outcome over 4.5 years.