ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31632 results sorted by trial registration date.
  • A Study to Find a Suitable Dose of ASP2802 in People With CD20-positive B-cell Lymphomas

    CAR-T cell therapy is a type of treatment for people with certain lymphomas. T-cells are white blood cells that help to fight infections. CAR-T cell therapy improves the body's T-cells to help them better fight cancer cells. ASP2802 is a type of CAR-T cell therapy given with MA-20. MA-20 is a protein that helps the CAR-T cell therapy work inside the body. Before ASP2802 is available as a treatment, the researchers need to understand how it is processed by and acts upon the body. This information will help find a suitable dose for future studies and check for potential medical problems from the treatment. In this study, ASP2802 is being tested in humans for the first time. ASP2802 has already been tested in the laboratory and in animals. This is the standard way new potential treatments are developed. People taking part in this study will be adults with CD20-positive B-cell lymphomas. CD20 is a protein found on a type of white blood cell called a B-cell. Some people with B-cell lymphomas have more CD20 on these cells. Their cancer will have come back after it had disappeared with earlier therapy (relapsed) or it will have become resistant to previous treatment (refractory). The main aims of the study are to check the safety of ASP2802, how well it is tolerated, and to find a suitable dose of ASP2802. This is an open-label, adaptive study. Open-label means that people in this study and clinic staff will know that people will receive ASP2802 treatment. Adaptive means the treatments may change, depending on earlier results in the study. There will be 3 groups of people in this study and 3 doses of ASP2802. Groups A, B and C will receive ASP2802 treatment. Group A will start treatment first with a low dose of ASP2802. If Group A tolerates the low dose of ASP2802, then Group B will receive the higher dose of ASP2802. If Group B tolerates the higher dose of ASP2802, then Group C will receive the highest dose of ASP2802. There are several steps in this treatment. First, T-cells are removed from the blood by inserting a small tube (cannula) into a vein and connecting it to a machine that separates out the blood cells. The machine collects the T-cells and returns the rest of the blood cells back into the bloodstream. The collected T-cells are sent to the lab to be changed into improved T-cells (with ASP2802) to fight the cancer. This may take several weeks, so people in the study may receive extra treatment, to keep the cancer under control during this time. Before the improved T-cells go back in the body, people will visit the clinic so that the study doctors can do a series of checks to make sure they are well enough to receive the T-cells. A few days before the improved T-cells go back into the body, people in the study will have chemotherapy for 3 days. This is to make sure the cancer is at its lowest level before people are treated with ASP2802. Then, the improved T-cells are fed back into the bloodstream using a drip attached to the cannula. After this, a booster of MA-20 will be given at the set dose by infusion on Day 3 and Day 17 in a 28-day cycle. If people respond well to treatment, they may stay on the same dose during the next cycle; if they have medical problems from the treatment, they may get a lower dose during the next cycle. The next group of people may receive a different dose (higher or lower) of MA-20 depending on the results from the previous group. People in the study will continue receiving MA-20 in this way until: they have certain medical problems from the treatment on the lowest dose of MA-20; they start other cancer treatment; their cancer gets worse; they or the study doctor decides they should stop treatment; they do not come back for treatment. After treatment has finished, people in the study will visit the clinic regularly for 2 years and continue to be monitored for up to 15 years. Some people may be treated again with MA-20. This may happen for people who have responded to treatment and then relapse within a year, or for people that have a partial response and have a slow growing lymphoma. During the study, people will visit the study hospital many times. During most visits, the study doctors will do a medical examination, blood tests and check vital signs. Vital signs include temperature, breathing rate, blood pressure, blood oxygen levels, and heart rate. They will also check for medical problems. In some visits, computerized tomography (CT) scans and electrocardiograms (ECGs) to check the heart rhythm will also be done. People will have several hospital stays during their treatment. This may be during their chemotherapy, then from Days -1 to 7 and Days 17 to 21 during the cycle 1 of MA-20. Day -1 means 1 day before treatment with ASP2802. During this time, people will be closely monitored for medical problems, have EGCs and have a biopsy taken. During the extra cycles of MA-20, there will be the option of staying overnight.

  • A Phase I/II, Dose Finding and Optimization Study of [177Lu]Lu-NeoB in Combination With Capecitabine in Patients With GRPR+, ER+, HER2- Metastatic Breast Cancer After Progression on Previous Endocrine Therapy in Combination With a CDK4/6 Inhibitor.

  • Study of CMP-CPS-001 in Healthy Volunteers

    The objective of this clinical study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of single and multiple ascending doses of CMP-CPS-001 administered as a subcutaneous injection in adult healthy volunteers.

  • A Safety and Efficacy Study of Dazodalibep in Participants With Sjögren's Syndrome (SS) With Moderate-to-Severe Symptom State

    Primary Objective: To evaluate the effect of dazodalibep on patient-reported symptoms of SS in participants with moderate-to-severe symptom state Secondary Objectives: 1. To evaluate the effect of dazodalibep on patient-reported outcomes (PROs) in participants with SS. 2. To evaluate the effect of dazodalibep on measures of systemic activity, PROs, and salivary flow in participants with SS 3. To evaluate the safety and tolerability of multiple doses of dazodalibep in participants with SS

  • A Study Evaluating FMC-376 in Participants With KRAS G12C Mutated Solid Tumors

    The goal of this clinical trial is to evaluate FMC-376 in participants with advanced solid tumors with KRAS G12C mutations. This clinical trial will be conducted in 3 parts: Phase 1A (Dose Escalation), Phase 1B (Dose Expansion), and Phase 2 (Cohort Expansion). Multiple dose levels in participants with advanced solid tumors will be evaluated.

  • Study to Investigate Safety and Tolerability of mRNA-0184 Administered Under Different Infusion Conditions in Healthy Participants

    The purpose of this study is to evaluate the safety and tolerability of intravenously (IV) administered mRNA-0184 under different infusion conditions.

  • Improving KIdney Transplantation with Cellular Therapy Study

    The i-KITCaT study aims to harness cellular therapies to favourably alter the immunological response to in AKI in transplantation. Kidney transplantation offers the best survival and quality of life outcomes for patients with end-stage kidney disease but requires life-long immunosuppression. Efforts to increase the donor organ pool means accepting kidneys which have been subjected to medical and surgical factors culminating in acute kidney injury (AKI). There is no treatment to modify the maladaptive injury process following an AKI insult, and this subjects the new kidney to increased risk of needing dialysis in the first 7 days of transplantation, rejection, and shortened transplant survival. Tolerogenic dendritic cells (TolDC) are currently used in phase I/II clinical trials and are safe for patients receiving a kidney transplant from the same donor as these cells. These trials focus on transplant tolerance, but we will re-purpose TolDCs to favorably alter the disease course following AKI and limit injury following transplantation. Furthermore, if the patient's own cells (rather than from a third-party donor) can be used, this avoids supply limitations and potential sensitization risk. We will compare the functional characteristics of TolDC generated from control (healthy) and kidney disease (chronic kidney disease (CKD), dialysis and transplantation).

  • Safety and Efficacy of MK-1200 in Participants With Advanced Solid Tumors (MK-1200-002)

    The purpose of this study is to assess the efficacy and safety of MK-1200 monotherapy in participants with advanced/metastatic gastric/gastroesophageal junction (GEJ) cancer, esophageal cancer, biliary tract cancer, and pancreatic ductal adenocarcinoma who have received, or been intolerant to, all treatments known to confer clinical benefit. Part 1 of the study will be a dose escalation to determine the maximum tolerated dose (MTD). Part 2 will evaluate safety and efficacy of MK-1200 at 2 different doses

  • A Study of MGC026 in Participants With Advanced Solid Tumors

    The study is designed to understand the safety, tolerability, pharmacokinetics, immunogenicity, and preliminary antitumor activity of MGC026 in participants with relapsed or refractory, unresectable, locally advanced or metastatic solid tumors The study has a dose escalation portion and a cohort expansion portion of the study. Participants will receive MGC026 by intravenous (IV) infusion. The dose of MGC026 will be assigned at the time of enrollment. Participants may receive up to 35 treatments if there are no severe side effects and as long as the cancer does not get worse. Participants will be monitored for side effects, and progression of cancer, have blood samples collected for routing laboratory work, and blood samples collected for research purposes.

  • A Study to Test Long-term Treatment With Spesolimab in People With a Skin Condition Disease Called Hidradenitis Suppurativa (HS) Who Took Part in a Previous Study With Spesolimab

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