Westwood

Researchers are studying a new treatment combination for adults with advanced breast cancer that is estrogen receptor positive, HER2 negative, and GRPR positive. The trial aims to find the recommended dose of the drug [177Lu]Lu-NeoB when given with ribociclib and fulvestrant to participants who have experienced early relapse after endocrine therapy or whose disease has progressed after endocrine therapy combined with a CDK4/6 inhibitor. This Phase 1 study includes a dose escalation part and a backfill part to assess safety, tolerability, and preliminary effectiveness. Participants will receive [177Lu]Lu-NeoB once every 28-day cycle for six cycles, ribociclib daily on days 1 to 21 of each cycle, and fulvestrant on specific days beginning at cycle 1. Pre- or perimenopausal women and men will also receive goserelin. The trial includes imaging with the radioactive agent [68Ga]Ga-NeoB at screening, possibly at cycle 2 day 15, and again 4 to 8 weeks after the last dose of [177Lu]Lu-NeoB to help locate cancer lesions. During the study, participants visit the clinic regularly for treatment, safety checks, and tumor assessments. Safety follow-up continues for 8 weeks after treatment ends, with extended monitoring every 12 to 24 weeks for up to 5 years to track side effects, adverse events, and treatment interruptions. Researchers will closely observe any dose-limiting toxicities and evaluate overall safety and effectiveness throughout the study period.

This research aims to collect long-term safety and effectiveness data for participants treated with ibrutinib, a medicine used for various blood cancers and conditions including Chronic Lymphocytic Leukemia, Small Lymphocytic Lymphoma, Mantle Cell Lymphoma, Follicular Lymphoma, Diffuse Large B-cell Lymphoma, Waldenstrom Macroglobulinemia, and Chronic Graft Versus Host Disease. It also provides ongoing access to ibrutinib for participants who have completed previous ibrutinib studies, continue treatment, and benefit from it. This is an open-label Phase 3b study without formal hypothesis testing. Participants will continue their current ibrutinib dosing regimen from the prior study, taken orally once daily as capsules in doses of 560 mg, 420 mg, 280 mg, or 140 mg, around the same time each day. Treatment continues until the investigator decides the participant no longer benefits due to disease progression or side effects, the participant withdraws, alternative ibrutinib access becomes available, or the study ends. Participants not able to access ibrutinib elsewhere can keep receiving the single-agent ibrutinib until all transition or stop treatment, or until the study is stopped. During the study, safety is monitored throughout and summarized, and effectiveness may be analyzed together with previous study data. The main outcome measured is the number of participants experiencing any adverse events within 30 days after the last dose or until starting another cancer treatment. Participants will undergo assessments including pregnancy testing and investigator evaluations to ensure ongoing benefit and safety. The study duration depends on when participants stop treatment or transition to other access.

Researchers are conducting a long-term follow-up study for people previously treated with ciltacabtagene autoleucel (cilta-cel), a CAR-T cell therapy targeting B-cell maturation antigen (BCMA) used in multiple myeloma. The study aims to collect data on delayed side effects and better understand the long-term safety of cilta-cel over a period of up to 15 years after the last dose. Participants in this study will not receive any new treatments. Instead, the study will track their health in two phases: from year 1 to year 5 after their last cilta-cel dose, then from year 6 up to year 15. Safety evaluations will include monitoring for new or worsening malignancies, neurological, rheumatologic, autoimmune, hematologic disorders, infections, and any serious adverse events. Participants will be followed at least once a year during the study. Assessments will include reviewing adverse events, lab test results, physical exams including neurological checks, and other safety data. This comprehensive monitoring will help researchers understand long-term effects and ensure ongoing participant safety throughout the 15-year follow-up.

Researchers are conducting a prospective, longitudinal, non-interventional, multicenter study to profile molecular biomarkers in patients with head and neck squamous cell carcinoma (HNSCC). The study focuses on individuals with metastatic or unresectable, recurrent HNSCC who are receiving standard of care treatment. The aim is to explore DNA, RNA, immune, and other multiomic biomarkers to better understand prognostic or predictive indicators that could inform future research on relevant biomarkers. Participants will provide tissue and blood samples for molecular biomarker profiling throughout their standard treatment, which involves first line anti-PD1 or PDL1 monotherapy or combination therapy. Tumor tissue samples representative of the current disease must be submitted according to laboratory guidelines. This observational study does not involve any investigational treatments or interventions beyond the participants' usual care. During the study, participants will undergo molecular analyses of their tissue and blood samples over a period of up to 5 years. Researchers will monitor multiomic biomarkers to identify prognostic or predictive factors. The study includes follow-up to collect data that may support the discovery of new biomarkers. Participants must be willing and able to comply with study procedures, including additional blood sample collections.

This research involves both pediatric and adult patients with various blood-related cancers and other disorders affecting the blood and immune system. It focuses on using unlicensed cryopreserved cord blood units (CBUs) for transplantation, aiming to study how well these unlicensed CBUs support recovery after transplant. The study also looks at important outcomes such as infection transmission, infusion reactions, survival rates, and graft-versus-host disease. Participants will receive transplants using these unlicensed cord blood units as part of a multicenter access and distribution protocol. The study is conducted at multiple U.S. transplant centers under the care of transplant physicians. The transplantation process involves administering these CBUs to patients with hematologic malignancies and other relevant conditions. Patients will be monitored for neutrophil recovery at 60 and 100 days post-transplant to assess engraftment success. Researchers will also evaluate infection rates, serious infusion reactions, survival one year after transplant, and incidences of acute and chronic graft-versus-host disease. Platelet recovery will be tracked as well. The study involves regular assessments to follow patients’ health and transplant outcomes over time.

Researchers are investigating the best drug combinations to prevent graft-versus-host disease (GVHD) in patients who have received a stem cell transplant from a mismatched unrelated donor with a different blood cell type. This Phase 2 platform protocol evaluates post-transplant cyclophosphamide (PTCy)-based GVHD prevention after mismatched unrelated donor hematopoietic cell transplantation in patients with malignant blood diseases. The study aims to assess the safety and effectiveness of various drug combinations compared to a standard treatment. Participants will receive either a new or standard drug combination after their transplant. Conditioning regimens before transplant include different combinations of chemotherapy and radiation, such as busulfan, fludarabine, melphalan, cyclophosphamide, and total body irradiation. On the day of transplant, donor peripheral blood stem cells (PBSCs) are infused. Post-transplant treatments include cyclophosphamide given on days 3 and 4, followed by drugs like tacrolimus, mycophenolate mofetil, abatacept, or ruxolitinib starting at different times. Supportive care such as growth factors, infection prevention, seizure prophylaxis, and monitoring for complications is provided. Additional investigational treatment arms may be added or closed during the study. Throughout the study, participants will have regular doctor visits for routine checks, blood and stool sample collections, and surveys about their physical and emotional health. Researchers will monitor outcomes such as graft-versus-host disease-free, relapse-free survival at one year after transplant. Safety monitoring includes infection prevention, immune function tests, and management of possible complications like cytokine release syndrome. The study tracks treatment adherence by recording administered agents and continues follow-up as required by the protocol.

Researchers are evaluating the effects of ASTX727 combined with iadademstat versus ASTX727 alone in patients with accelerated or blast phase Philadelphia chromosome-negative myeloproliferative neoplasms (MPNs), including subtypes like polycythemia vera and myelofibrosis. This phase II trial aims to compare the complete acute leukemia response rate within four 28-day treatment cycles and assess survival outcomes and transplant rates. The study also explores molecular changes and resistance pathways related to these treatments. Participants are randomly assigned to one of two groups: one receives ASTX727 alone, which is a combination of decitabine and cedazuridine taken orally once daily on days 1 through 5 of each cycle; the other group receives the same ASTX727 dosing plus iadademstat taken orally on days 1-5, 8-12, 15-19, and 22-26. Treatment cycles repeat every 28 days until disease progression or unacceptable side effects occur. The study includes a dose escalation phase before randomization. During the study, participants undergo buccal swab, blood sample collections, and bone marrow aspiration and biopsy to monitor disease and treatment effects. After stopping treatment for reasons other than disease progression, patients are followed up every three months; if stopping due to progression, follow-up occurs every six months. Researchers measure treatment response using established leukemia criteria and track safety and overall survival throughout the study.

Researchers are investigating the safety and effectiveness of CTX112, an allogeneic CD19-directed CAR T cell immunotherapy, in adults with relapsed or refractory B-cell malignancies. This open-label, multicenter Phase 1/2 study focuses on patients whose cancer has returned or not responded to prior treatments, including various types of B-cell lymphoma and leukemia. CTX112 is created by genetically modifying donor T cells using CRISPR-Cas9 technology to target cancer cells. Participants receive CTX112 infusions as part of two study phases. Phase 1 involves dose escalation to evaluate safety and identify dose-limiting toxicities, monitored from infusion through 28 days afterwards. Phase 2 expands the participant group to assess the objective response rate over a longer period, up to 60 months post-infusion. This design allows researchers to study both short-term safety and longer-term treatment effects. Throughout the study, participants undergo regular assessments including physical exams, laboratory tests, and monitoring for adverse events. Female and male participants must use contraception during the study and for 12 months after treatment. The study tracks responses to therapy and any side effects to better understand the potential benefits and risks of CTX112 in this patient population.

Researchers are evaluating SEA-CD70, alone and combined with azacitidine, in adults with myeloid malignancies including myelodysplastic syndrome (MDS) and acute myeloid leukemia (AML). This phase 1, open-label study aims to find safe dosing levels, assess side effects, and explore whether these treatments work. The trial includes several parts, each focused on different patient groups and treatment combinations, including those who are relapsed, refractory, or untreated, and those unfit for standard chemotherapy. The study involves seven parts: dose-finding for SEA-CD70 alone (Part A) and with azacitidine (Part D), safety and tolerability expansions for SEA-CD70 monotherapy in MDS (Part B) and AML (Part C), and expansions for SEA-CD70 with azacitidine in untreated or relapsed/refractory MDS or MDS/AML (Parts E and F). Part G evaluates dosing and safety 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 cycle; azacitidine is administered subcutaneously or intravenously on days 1 through 7; venetoclax is taken orally daily with dose ramping. Participants will be monitored for side effects, laboratory abnormalities, and dose-limiting toxicities during and up to about two years after the last dose. Safety, tolerability, and antitumor activity will be evaluated through clinical assessments, laboratory tests, and patient monitoring throughout the study. The study duration varies by part, including dose escalation, expansion, and follow-up periods to assess long-term safety and efficacy outcomes.

This research aims to evaluate the safety and effectiveness of BMS-986504, a selective PRMT5 inhibitor, when combined with Nab-paclitaxel and Gemcitabine, compared to a placebo combined with Nab-paclitaxel and Gemcitabine. The study focuses on participants with untreated metastatic Pancreatic Ductal Adenocarcinoma (PDAC) who have a specific genetic alteration called homozygous MTAP deletion. This is a randomized Phase 2/3 trial designed to explore treatment options for this patient population. Participants will be assigned to receive either BMS-986504 at specified doses on certain days along with Nab-paclitaxel and Gemcitabine, or a placebo with the same chemotherapy drugs. The treatments are given according to protocol schedules. Some participants may have received up to one cycle of Nab-paclitaxel and Gemcitabine before starting the study treatment, provided they did not experience disease progression or intolerable side effects. The initial cycle must be completed before randomization. During the study, researchers will monitor participants for progression-free survival and overall survival for up to three years after the last participant is randomized. Assessments include measuring tumor response using established criteria (RECIST v1.1). Participants will undergo evaluations to track safety, treatment effects, and disease status throughout the trial period.