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Kingdom",{"type":36,"coordinates":202},[203,204],-0.12574,51.50853,{"lat":204,"lon":203},{"facility":29,"status":30,"city":207,"state":20,"zip":208,"country":200,"cosmosGeoPoint":209,"geoPoint":213,"contacts":20},"Newcastle upon Tyne","NE7 7DN",{"type":36,"coordinates":210},[211,212],-1.61396,54.97328,{"lat":212,"lon":211},{"type":215,"investigatorFullName":20,"investigatorTitle":20,"investigatorAffiliation":20,"oldNameTitle":20,"oldOrganization":20},"SPONSOR","100602434",false,"NCT07123454","A Phase I\u002FII Study of AZD4512 Monotherapy or in Combination With Anticancer Agents in Participants With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma","A Modular Phase I\u002FII Open-label, Multicenter Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, Immunogenicity, and Efficacy of AZD4512 Monotherapy or in Combination With Other Anticancer Agent(s), in Participants With Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL) (Lumi-NHL)","Lumi-NHL","Key Inclusion Criteria:\n\n* Eligible patients must be adults (≥18 years)\n* Documented histologically confirmed diagnosis of B-cell non-Hodgkin lymphoma (B-NHL) as per World Health Organization (WHO) 2022 classification. In the dose escalation phase, any B-NHL subtype is allowed (excluding some subtypes), while the backfill phase restricts inclusion to defined subtypes: large B-cell lymphomas (as defined as Diffuse large B-cell lymphoma (DLBCL), Grade 3b Follicular lymphoma (FL), high-grade B-cell lymphoma (HGBCL) NOS, DLBCL\u002FHGBCL with MYC and BCL2 rearrangements, primary mediastinal Large B-cell lymphoma, T-cell\u002Fhistiocyte-rich LBCL, and transformed indolent lymphoma) and mantle cell lymphoma.\n* Patients must have relapsed or refractory disease after at least two prior lines of systemic therapy and lack additional standard options with established benefit:\n\nA)LBCL patients must have progressed after both anti-CD20 and at least one systemic chemotherapy regimen, and have considered-or be ineligible for-CAR-T, T cell engager, and stem cell transplant modalities.\n\nB) Mantle cell lymphoma (MCL) patients must have had anti-CD20 and Bruton's Tyrosine Kinase (BTK) inhibitor.\n\nAdditional criteria include measurable disease by Lugano 2014, Eastern Cooperative Oncology Group (ECOG) performance status ≤2, and adequate organ and bone marrow function (as specified by blood counts, cardiac ejection fraction, renal and hepatic parameters, and coagulation indices).\n\nKey Exclusion criteria\n\n* Patients are excluded if they have a diagnosis of post-transplant lymphoproliferative disease, Richter's transformation, Burkitt's lymphoma, or chronic lymphocytic leukemia (CLL)\u002F Small lymphocytic lymphoma (SLL), Waldenstrom Macroglobulinemia\u002F Lymphoplasmacytic Lymphoma, or if they have active Central nervous system (CNS) involvement from their B-NHL. Exclusion also applies to those who have received Chimeric antigen receptor-T (CAR-T) or T cell engager therapies within 90 days prior to Cycle 1 Day 1 (C1D1), any investigational drug or other systemic anticancer therapies (except low-dose corticosteroids) within 21 days or 5 half-lives, and curative radiation within 14 days (localized palliative radiotherapy is allowed).\n* Other exclusions include allogeneic Hematopoietic stem cell transplantation (HSCT) within 180 days (unless stable without active (graft-versus-host disease) GVHD for ≥2 months), autologous HSCT within 90 days (unless resolved toxicities), major surgery within 28 days, use of strong CYP3A inhibitors within 14 days or 5 half-lives before the dosing date, use of QTc-prolonging agents within 5 half-lives before the dosing date, or other malignancies within two years. Patients with unresolved ≥ Grade 2 AEs from prior therapy (except specified tolerable conditions), serious uncontrolled medical conditions, active infection within 14 days, or history\u002Fsuspicion of significant interstitial lung disease\u002Fpneumonitis are also excluded.\n* Females who are pregnant or breastfeeding are not eligible.","ALL","18 Years",{"count":226,"type":227},91,"ESTIMATED","INTERVENTIONAL",[230,231],"PHASE1","PHASE2","This is a Phase I\u002FII open-label, global multicenter study to evaluate the safety and efficacy of AZD4512 monotherapy or in combination with other anticancer agent(s), in participants with Relapsed\u002FRefractory B-cell Non-Hodgkin Lymphoma (B-NHL).",[234],"B-cell Non-Hodgkin Lymphoma",[17,236,237],"Non-Hodgkin Lymphoma (NHL)","Relapsed\u002FRefractory","2026-06-26",{"date":240,"type":241},"2026-06-29","ACTUAL",{"date":243,"type":241},"2025-09-24",{"date":245,"type":227},"2028-03-01",{"name":5,"class":6},22]