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Researchers are evaluating a new treatment approach for people with metastatic pancreatic ductal adenocarcinoma PDAC who have progressed after initial therapy with certain chemotherapy combinations. The study focuses on assessing the safety, tolerability, and overall survival when adding an experimental therapy called E-EDV-D682GC to standard chemotherapy drugs gemcitabine and nab-paclitaxel. This trial is a randomized, blinded Phase IIIa study designed to compare this combination against gemcitabine and nab-paclitaxel alone. The experimental treatment includes two investigational products E-EDV-D682, which packages a chemotherapy agent targeted to cancer cells expressing EGFR, and EDV-GC, which aims to boost the bodys immune response. Participants receive these drugs alongside gemcitabine and nab-paclitaxel. The trial has two parts an initial safety phase with at least six participants receiving the experimental combination to check for side effects, followed by a randomized phase where participants are assigned either to the experimental combination or to standard chemotherapy with placebo. Treatment cycles involve bi-weekly then weekly visits, with tumor assessments every 8 weeks to monitor response. Participants will be involved for about six months, including screening, treatment, and follow-up. They will undergo regular clinical visits, imaging scans to measure tumor burden, and safety assessments throughout the study and for up to 30 days after treatment ends. Researchers will monitor adverse events and overall survival, as well as measure disease progression and response using established imaging criteria. The study also includes a safety follow-up period to closely track participants health after treatment.

Researchers are evaluating the safety and preliminary effectiveness of a combination treatment involving M-CENK adoptive cell therapy, N-803, and gemcitabine in women with platinum-resistant high-grade ovarian cancer. This phase 2, single-arm study focuses on participants whose cancer has returned despite previous platinum-based chemotherapy and other therapies including bevacizumab and, if applicable, PARP inhibitors. The study aims to understand how this combination affects disease progression and survival. Participants will undergo a blood collection procedure called apheresis to gather cells needed to create M-CENK therapy. Treatment starts with gemcitabine given intravenously on specific days in 4-week cycles. From the second cycle onward, participants will also receive M-CENK cell infusions intravenously and N-803 injections under the skin. N-803 dosing continues with additional doses spaced two weeks apart after the last M-CENK infusion. Treatment continues until M-CENK cells are no longer available or disease progression is confirmed, unless the investigator believes the participant is still benefiting. During the study, participants are closely monitored through regular assessments including imaging to evaluate tumor response and progression. Safety is evaluated through laboratory tests, vital signs, and tracking adverse events. After completing or stopping treatment, participants will be followed every 12 weeks for up to one year to monitor survival and disease status. The study measures several outcomes such as progression-free survival, overall survival, response rates, and disease control, assessing the impact of the combined therapies over time.

Researchers are studying the safety and effectiveness of Anktiva, also known as Nogapendekin Alfa Inbakicept NAI, in people experiencing Long COVID, which means continuing symptoms after a COVID-19 infection has ended. This Phase 2 study aims to understand how this treatment may help patients with persistent symptoms that affect their quality of life. The study is sponsored by ImmunityBio, Inc. and focuses on adults aged 18 to 70 years with confirmed Long COVID symptoms lasting at least 60 days. Participants will receive 600 micrograms of Anktiva administered by a subcutaneous injection. The study is a single-arm trial, meaning all participants receive this treatment without comparison to a placebo or other drug. Treatment and monitoring will occur over approximately 75 days, including the time after the final dose to track safety and response. There are no placebo groups or blinding in this research. During the study, participants will attend visits for assessments including blood tests, vital signs monitoring temperature, heart rate, blood pressure, respiratory rate, oxygen saturation, and symptom evaluations. Researchers will monitor for any treatment-related side effects or serious adverse events up to 30 days after the last dose. They will also assess changes in lymphocyte counts and other laboratory values. Participants should expect regular study visits and evaluations for safety and effectiveness over the treatment period.

Researchers are conducting a randomized, open-label phase 3 clinical trial to compare the effectiveness and safety of two treatment combinations with docetaxel alone in people with advanced or metastatic non-small cell lung cancer NSCLC who have developed resistance to immune checkpoint inhibitor therapy. The study includes two groups one receiving N-803 plus tislelizumab and docetaxel, and the other receiving N-803 plus a prior failed checkpoint inhibitor and docetaxel. The trial explores how these combinations perform compared to docetaxel by itself in this specific patient population. Participants are divided into two cohorts and randomized to either the experimental treatments or docetaxel monotherapy. Treatments are given in repeated 3-week cycles. In cohort A, N-803, tislelizumab, and docetaxel are given during the first two cycles, followed by N-803 and tislelizumab alone from cycle 3 onward until the study ends. In cohort B, N-803, the prior failed checkpoint inhibitor, and docetaxel are administered in the first two cycles, then N-803 with the prior checkpoint inhibitor continue from cycle 3 onward. The control groups in both cohorts receive docetaxel alone every 3 weeks. Participants will attend regular study visits aligned with the treatment cycles, during which researchers will assess overall survival and monitor safety. The main measurement focuses on comparing survival between the experimental and control arms over approximately 12 months. The study involves follow-up visits and safety monitoring throughout the treatment period. The trial is sponsored by ImmunityBio, Inc. and plans to enroll adults aged 18 to 90 with confirmed stage IV NSCLC who meet specific health and treatment history criteria.

Researchers are conducting a first-in-human, multicenter, open-label Phase 12 study to evaluate AT-1965 in patients with advanced, refractory, or recurrent solid tumors, including metastatic triple-negative breast cancer. The study aims to identify the maximum tolerated dose or recommended Phase 2 dose of AT-1965 and to assess dose limiting toxicities, safety, pharmacokinetics, pharmacodynamics, and preliminary antitumor activity. Participants will receive AT-1965 Liposome Injection administered intravenously once weekly on Days 1, 8, and 15 of each 28-day treatment cycle. The study consists of a dose escalation phase to determine safe dosing followed by a dose expansion phase to further evaluate the treatment in a larger group. Treatment cycles repeat every 28 days, with dosing and assessments continuing as per protocol. During the study, participants will undergo safety monitoring, pharmacokinetic and pharmacodynamic testing, and tumor assessments using RECIST criteria at 3, 6, and 9 months. Adverse events and serious adverse events will be tracked from consent through 30 days after the last dose. Laboratory tests and clinical evaluations occur regularly during treatment cycles. The total participation duration varies, with ongoing safety and efficacy evaluations throughout the study period.