Westwood

Researchers are studying the combination of 177LuLu-NeoB with ribociclib and fulvestrant in adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and gastrin releasing peptide receptor positive. This trial focuses on participants who have experienced early relapse after endocrine therapy or whose disease has progressed on endocrine therapy combined with a CDK46 inhibitor. The goal is to find the recommended dose of 177LuLu-NeoB when used with these other treatments. The trial consists of a dose escalation phase testing four planned doses of 177LuLu-NeoB 100, 150, 200, and 250 millicurie in small groups, followed by a backfill phase to gather additional safety and preliminary effectiveness data at an established dose. Participants receive 177LuLu-NeoB once every 28-day cycle for six cycles, along with daily ribociclib for the first 21 days of each cycle and fulvestrant on specific days starting from cycle 1 day 1. Pre- and perimenopausal women and men also get goserelin each cycle. Imaging with 68GaGa-NeoB is done during screening, possibly at cycle 2 day 15, and after treatment to assess disease. Participants attend clinic visits every 28 days for treatment, safety checks, and dosimetry assessments, with additional visits early in cycles 1, 2, 3, and 5. Tumor evaluations occur every 8 weeks up to 18 months, then every 12 weeks until 36 months, and further as needed. Safety follow-up lasts 8 weeks after treatment ends, followed by long-term monitoring every 12 to 24 weeks until 5 years from enrollment or until withdrawal, death, or loss to follow-up. Researchers measure dose-limiting toxicities, adverse events, dose changes, drug levels in blood, tumor responses, and survival outcomes.

Researchers are collecting long-term safety and effectiveness data for participants treated with ibrutinib, a first-in-class, orally taken medicine that targets Brutons tyrosine kinase. The study focuses on individuals who have already been treated with ibrutinib in prior studies and are continuing to benefit from the treatment. The goal is to provide ongoing access to ibrutinib while monitoring health outcomes over time. Participants will continue taking ibrutinib capsules once daily at the dose established in their previous study ranging from 140 mg to 560 mg until the doctor decides the treatment is no longer helping, the participant chooses to stop, or other specified reasons occur. Some participants may receive ibrutinib alone or in combination with nivolumab depending on their prior treatment. The study is open-label, meaning everyone knows the treatment being given. During the study, participants are regularly monitored for safety and disease changes through assessments and visits until they stop the study drug or move to other treatments. Researchers track side effects up to 30 days after the last dose and may analyze how the disease responds in combination with earlier study data. The study continues until all participants transition off study treatment or the sponsor ends the trial, ensuring ongoing care and data collection over time.

This research aims to collect long-term follow-up data to understand delayed side effects and the overall long-term safety profile of ciltacabtagene autoleucel cilta-cel, an autologous CAR-T therapy targeting B-cell maturation antigen BCMA in people who have previously received this treatment. The study focuses on participants treated for multiple myeloma and monitors safety concerns that may arise years after treatment. The study involves no new treatment administration. It consists of two phases the first phase covers up to 5 years after the participants last dose of cilta-cel, and the second phase follows from year 6 up to 15 years after that dose. Participants are monitored at least once a year for delayed adverse events, including new or worsening malignancies, neurological disorders, autoimmune conditions, serious infections, and hematologic disorders. During the study, participants undergo safety evaluations such as physical exams, neurological assessments, laboratory tests, and review of adverse events. Researchers will measure outcomes including incidence of serious adverse events, infections, malignancies, and autoimmune disorders over the entire 15-year period. No new treatment is given, and participants will be followed long term to gain knowledge about cilta-cels safety and survival outcomes.

Researchers are conducting a prospective, longitudinal, non-interventional study involving participants with metastatic or unresectable recurrent head and neck squamous cell carcinoma HNSCC. The study focuses on molecular biomarker profiling using tissue and blood samples collected during participants standard care treatment, aiming to enhance understanding of prognostic and predictive biomarkers over a five-year period. Participants planned for first-line immunotherapy or combination therapy will be included, with no additional interventions applied by the study. Up to 500 participants with tumors located in the pharynx, larynx, oral cavity, or oropharynx will be observed. Tissue samples representative of current disease and longitudinal blood samples will be collected to analyze DNA, RNA, immune, and other multiomic biomarkers. Throughout the study, participants will undergo biomarker assessments from blood and tumor tissue collected at diagnosis and progression. Researchers will explore changes in circulating tumor DNA ctDNA and other biomarkers to understand treatment responses and resistance mechanisms. The study will last up to five years, focusing on real-world outcomes and biomarker evolution during routine care without altering treatment plans.

Researchers are studying the use of unlicensed cryopreserved cord blood units CBUs for transplantation in both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood-forming system. This observational study aims to evaluate outcomes such as the recovery of a certain level of white blood cells after transplantation, as well as the incidence of infections, infusion reactions, survival rates, and graft-versus-host disease over time. The study involves patients receiving unlicensed CBUs at multiple U.S. transplant centers. These CBUs are used for patients with hematologic malignancies and other blood disorders. The protocol collects data on patients who receive these unlicensed transplant units, without administering a new treatment but observing the outcomes after transplantation. Participants will be monitored for neutrophil recovery at 60 and 100 days post-transplant, along with assessments of infection transmission, infusion reactions, survival one year after transplant, and occurrences of acute and chronic graft-versus-host disease. Platelet engraftment levels will also be tracked. The study includes patients of any age and follows them through the transplantation and recovery process to gather information on these key outcomes.

Researchers are evaluating drug combinations to prevent graft-versus-host disease GVHD in people who have received stem cell transplants from unrelated donors with different blood types. This platform protocol focuses on safety and effectiveness of post-transplant cyclophosphamide PTCy based GVHD prevention after mismatched unrelated donor hematopoietic cell transplants in patients with malignant blood diseases. The study compares new drug combinations to a standard treatment. Participants receive one of the drug combinations after transplant, including investigational arms named ACCEL-001 and ACCEL-002, or the shared comparator control group. Conditioning regimens vary and may include combinations of drugs such as busulfan, fludarabine, melphalan, cyclophosphamide, and total body irradiation before transplant. The donor stem cell graft infusion occurs on Day 0, followed by specific post-transplant medications like cyclophosphamide, tacrolimus, mycophenolate mofetil, abatacept, and ruxolitinib, with supportive care for infection prevention and other complications. During the study, participants have regular doctor visits for check-ups and routine tests, complete surveys on physical and emotional health, and provide blood and stool samples. Researchers monitor outcomes including graft-versus-host disease-free, relapse-free survival one year after transplant, infection rates, survival, graft failure, and immune recovery. Safety is closely tracked, including monitoring for cytokine release syndrome and infections. The study lasts for at least one year post-transplant, with detailed data collection on treatment response and side effects.

Researchers are evaluating CTX112, an allogeneic CD19-directed chimeric antigen receptor CAR T cell immunotherapy, in adults with relapsed or refractory B-cell malignancies. This open-label, multicenter Phase 12 study aims to assess the safety and effectiveness of CTX112, which uses genetically modified T cells edited with CRISPR-Cas9 technology to target cancer cells. The study is sponsored by CRISPR Therapeutics AG and includes patients with various B-cell cancers such as lymphoma and leukemia. Participants receive CTX112 through an intravenous infusion after undergoing lymphodepleting chemotherapy to prepare their bodies. The Phase 1 portion focuses on dose escalation to evaluate safety and identify dose-limiting toxicities within 28 days after infusion. In Phase 2, the study expands to assess objective response rates over up to 60 months. The treatment involves only the CTX112 product administered by IV infusion. During the study, participants will be closely monitored for adverse events, treatment response, and disease progression through clinical assessments and laboratory tests. Researchers will measure outcomes such as duration of response, progression-free survival, and overall survival for up to five years following infusion. Female participants of childbearing potential and male participants must use contraception during the study and for one year afterward. The study excludes those with certain infections, prior transplants, CNS involvement, and other specific medical conditions to ensure participant safety.

Researchers are evaluating a drug called SEA-CD70, alone and combined with azacitidine, to assess its safety and potential effects in adults with myelodysplastic syndrome MDS and acute myeloid leukemia AML. This phase 1, open-label study aims to find appropriate dosing and understand side effects and antitumor activity in participants with relapsed or refractory disease as well as previously untreated higher-risk cases. The trial is sponsored by Seagen, a subsidiary of Pfizer, and includes several parts to address different patient groups and treatment combinations. The study consists of seven parts dose escalation and expansion of SEA-CD70 monotherapy for relapsedrefractory MDS and AML dose-finding and expansion of SEA-CD70 combined with azacitidine for relapsedrefractory and untreated higher-risk MDS or MDSAML and dose-finding of SEA-CD70 with azacitidine and venetoclax in untreated AML patients unfit for standard chemotherapy. SEA-CD70 is given intravenously on Days 1 and 15 of each treatment cycle, azacitidine is given either subcutaneously or intravenously on Days 1 through 7, and venetoclax is taken orally daily with dose ramping. Participants will undergo safety and tolerability assessments, laboratory tests, and pharmacokinetic analyses through approximately two years after the last dose. Researchers will monitor adverse events, dose-limiting toxicities, and laboratory abnormalities. Secondary measures include response rates, remission durations, survival rates, and drug concentration levels. The study evaluates how well participants tolerate the treatments and examines the drugs effects on disease progression over up to four years.

Researchers are evaluating the combination of pembrolizumab and sacituzumab govitecan-hziy compared to standard chemotherapy treatments in patients with urothelial cancer that has spread locally or to other parts of the body. This phase III trial aims to assess overall survival, progression-free survival, response rates, clinical benefit, and treatment safety. The study also explores quality of life and fatigue changes during treatment to better understand patient experiences. Participants are randomly assigned to one of two groups. One group receives standard chemotherapy options such as carboplatin or cisplatin with gemcitabine, or alternatively docetaxel or paclitaxel, given intravenously in cycles every 21 days for up to six cycles. The other group receives pembrolizumab intravenously on day 1 and sacituzumab govitecan-hziy intravenously on days 1 and 8 of each 21-day cycle, continuing for up to 35 cycles or two years, unless the disease progresses or toxicity occurs. Both groups undergo blood sample collection and imaging scans like CT or MRI throughout the study. During the study, participants will have regular visits for treatment administration, blood tests, and imaging to monitor disease status and treatment effects. Researchers will collect data on survival, tumor response, side effects, and quality of life using questionnaires at multiple time points up to five years from the start of treatment. After finishing treatment, patients are followed up 30 days later and then once a year for five years to track long-term outcomes and safety.

Researchers are evaluating the anti-tumor activity and safety of amivantamab given as a subcutaneous co-formulation with recombinant human hyaluronidase PH20 rHuPH20 in participants with advanced or metastatic non-small cell lung cancer NSCLC, including those with specific EGFR mutations. This Phase 2, open-label study includes multiple cohorts with different treatment histories and EGFR mutation types to better understand how amivantamab works in combination with other therapies and to assess its safety profile. Participants receive amivantamab subcutaneously at varying doses based on body weight and specific treatment cohorts. Some cohorts combine amivantamab with oral lazertinib or intravenous chemotherapy drugs such as carboplatin and pemetrexed, administered on different schedules ranging from every two to three weeks in 21- or 28-day cycles. Additional treatments like prophylactic anticoagulation may also be given in certain cohorts. Participants may have the option to enter a long-term extension phase to continue receiving study treatments. During the study, participants undergo regular evaluations including tumor assessments based on RECIST criteria and safety monitoring through adverse event tracking and laboratory tests. Researchers will measure objective response rates and other outcomes up to 1 year and 6 months, and for some cohorts, safety will be monitored for up to nearly 5 years. Participants quality of life and treatment satisfaction are also assessed. The total duration of participation varies according to cohort and treatment response, with follow-up continuing after treatment completion.