Simulect (basiliximab) / Novartis - LARVOL DELTA

A novel reduced-toxicity conditioning regimen with busulfan/fludarabine/cyclophosphamide/anti-thymocyte globulin for severe aplastic anemia (ASH 2025) - "The conditioning regimen comprised Bu (0.8 mg/kg every 6 hours, 1 day, weight-adjusted dose for pediatric patients), Flu (30 mg/m²/day, 4 days), Cy (500 mg/m²/day, 4 days), and ATG with Thymoglobulin 2 mg/kg/day, 4 days in 3 patients or ATG-Fresenius 5 mg/kg/day, 4 days in 7 patients. Graft-versus-host disease (GVHD) prophylaxis included cyclosporine and mycophenolate mofetil for all patients, supplemented with either: short-term methotrexate(MTX, +1d 15mg/m², +4d, +8d, +11d 10mg/m², n=2); only CD25 monoclonal antibody(Basiliximab, +3d 20mg, n=1); or both(MTX as above plus Basiliximab, +3d 20mg, n=2; or MTX as above plus Recombinant humanized anti-CD25 monoclonal antibody, +4d, +8d, 1mg/kg, n=5)...Majority of the patients are with good quality of life. Longer follow-up and larger series are needed to evaluate fertility and transplant outcomes with current protocol."

Acute Graft versus Host Disease • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Immunology

A US real-world analysis of demographics, transplant patterns, and survival outcomes in posttransplant lymphoproliferative disorder (PTLD) (ASH 2025) - "Other agents includedprednisone (6.2%), cyclosporine (5.8%), sirolimus (5.8%), dexamethasone (4.8%), azathioprine (3.1%),methylprednisolone (1.9%), everolimus (0.7%), ibrutinib (0.6%), ruxolitinib (0.6%), mycophenolate(0.3%), basiliximab (0.2%), and thymoglobulin (0.1%).Extranodal, bone marrow, and CNS involvement were present in 29.5%, 1.9%, and 1.8% of cases,respectively...Median OSfor heart transplant recipients was 2730 days, and for those who underwent HSCT, 2643 days.Regarding treatment, only 10 patients received bispecific antibodies (glofitamab, epcoritamab, ormosunetuzumab) and only 23 patients received CAR-T therapy. This study represents one of the largest real-world analyses of PTLD in adult patients inthe US, utilizing the TriNetX dataset spanning over three decades. This study represents one of the largest real-world analyses of PTLD in adult patients inthe US, utilizing the TriNetX dataset spanning over three decades. Improvement in OS in more recentyears..."

Clinical • Post-transplantation • Real-world • Real-world evidence • Bone Marrow Transplantation • Epstein-Barr Virus Infections • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Solid Organ Transplantation • Transplantation

Vedolizumab for treating steroid-refractory lower gastrointestinal acute graft-versus-host disease: a single-center real-world study (ASH 2025) - "24.6%(17/69) received VDZ as second-line therapy, and 75.4% (52/69) as third-line therapy, and all received VDZin combination with basiliximab...No significant differences were observed regarding theline of VDZ therapy (P=0.365), duration of treatment (P=0.232), aGVHD severity before VDZ treatment(P=0.235), or concomitant first-line ruxolitinib use (P=0.187).The one-year incidence of cGVHD was 26.1% (18/69)...Infections were the most common complications, including pneumonia(59.4%, 41/69), bloodstream infections (18.8%, 13/69), urinary tract infections (14.5%, 10/69),cytomegalovirus viremia (18.8%, 13/69), and Epstein-Barr virus viremia (15.9%, 11/69).ConclusionVDZ demonstrated remarkable efficacy and safety as a second-line or third-line therapy for SR-LGI-aGVHD. This treatment approach achieved rapid and durable remission while improving survival ratesand reducing steroid dependence."

Clinical • Real-world • Real-world evidence • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Gastrointestinal Disorder • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Nephrology • Pneumonia • Respiratory Diseases • IL12A • TNFA

First-in-human phase I trial combining radiopharmaceutical therapy (RPT) using a 90y-anti-CD25 monoclonal antibody (Mab) with total marrow and lymphoid irradiation (TMLI) in relapsed or refractory (R/R) acute leukemia (ASH 2025) - P1 | "In older patients with R/R acute leukemia, conditioning with TMLI 12 Gy, fludarabine(flu), and melphalan (mel) resulted in a 5-year overall survival (OS) and event-free survival (EFS) of 42%and 41%, respectively [Jensen et al...In this trial (NCT05139004) we evaluated adding anti-CD25 Mab radiolabeled with 90Y (a β-emitting therapy radionuclide) to TMLI 12 Gy, flu and mel in thissame population. The primary objective of this 3+3 design phase I trial was to determine the maximum tolerateddose (MTD) and dose-limiting toxicities (DLTs) of 90Y-anti-CD25 Mab (Basiliximab) (Day -15) combined with12 Gy TMLI (1.5 Gy twice daily, days -8 to -5), flu (30 mg/m2/d days -5 to -2), and mel (100 mg/m2, day -2) inpatients > 60 years old (or in younger patients with a HCT-comorbidity index > 2) with R/R acute leukemiascheduled for alloHCT with a matched donor...Tacrolimus and sirolimus werestarted on day -1 and tapered at day 90 in the absence of GVHD. 7 patients with R/R AML..."

First-in-human • P1 data • Acute Graft versus Host Disease • Anorexia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • TP53

Impact of induction agent selection on rejection, allograft function, and survival in kidney transplant recipients. (PubMed, Transpl Immunol) - "Basiliximab showed similar acute rejection rates to lymphocyte-depleting agents, suggesting it is not inferior in preventing early rejection when used for a selected group of patients. These findings support the need for further multi-center studies to better define optimal induction strategies and adapt therapy to individual patient profiles."

Journal • Transplant Rejection • Transplantation

Medical Product Alert N°6/2025: Falsified SIMULECT (basiliximab) for injection (World Health Organization) - "The falsified product has been detected in Rwanda, Bulgaria, and Türkiye, and was reported to the WHO in December 2024 and November 2025...The falsified product shows batch number SFYD2, which is not a valid batch number for SIMULECT. Any SIMULECT product with batch number SFYD2 should be considered falsified....The falsified product label displays the National Drug Code NDC 0078-0331-84. While the National Drug Code (NDC) is a unique identifier for medicines marketed in the United States of America, the label contains other discrepancies compared to genuine SIMULECT packaging."

Commercial • Transplant Rejection

Chronic kidney disease at one year after liver transplantation: Role of changes in immunosuppression over three decades. (PubMed, World J Transplant) - "Age, female sex, pre-transplant RD, and CsA are associated with increased risk of CKD within 1 year after LT. Addition of MPA to Tac is associated with lower RD incidence."

Journal • Chronic Kidney Disease • Hepatology • Nephrology • Renal Disease • Transplantation

In Vitro Evaluation of Basiliximab as an Induction Therapy for Xenotransplantation. (PubMed, Xenotransplantation) - "Basiliximab can significantly reduce the xenoreactivity of human lymphocytes against TKO pig cells, and its inhibitory effect is no less than that on allogeneic T cell responses, supporting its potential as induction therapy in xenotransplantation."

Journal • Preclinical • Transplant Rejection • Transplantation • CD4 • CD8 • IFNG • IL2RA • TNFA

Yttrium-90 Labeled Anti-CD25 Monoclonal Antibody Combined With BEAM Chemotherapy Conditioning for the Treatment of Primary Refractory or Relapsed Hodgkin Lymphoma (clinicaltrials.gov) - P2 | N=33 | Recruiting | Sponsor: City of Hope Medical Center | Trial completion date: Oct 2027 ➔ Oct 2029 | Trial primary completion date: Oct 2027 ➔ Oct 2029

Trial completion date • Trial primary completion date • Hematological Malignancies • Hodgkin Lymphoma • Lymphoma • Oncology • Transplantation • CD34

Acute T-Cell Rejection after Living-Donor Kidney Transplantation: Monitoring with Urinary Presepsin. (PubMed, Cureus) - "A standard immunosuppressive protocol was administered with steroids, basiliximab, mycophenolate mofetil (MMF), and tacrolimus. On postoperative day 5, he contracted COVID-19 and was treated with molnupiravir; however, antigen positivity persisted, leading to a reduction in MMF...Urinary presepsin levels at the time of TCMR and at the three-month and one-year protocol biopsies were 13,075, 1,332, and 680 ng/g creatinine, respectively, correlating with changes in renal function and histological findings. This case suggests that urinary presepsin may be a valuable noninvasive biomarker for monitoring disease activity in TCMR."

Journal • Focal Segmental Glomerulosclerosis • Glomerulonephritis • Infectious Disease • Novel Coronavirus Disease • Transplantation

Evaluating the Role of Basiliximab Induction in Simultaneous Liver-Kidney Transplantation: A Multicenter Propensity-Score-Matched Analysis. (PubMed, Antibodies (Basel)) - "SLK recipients without basiliximab induction had comparable rejection outcomes but more viral infections, potentially from greater steroid exposure, and more liver biopsies, which may reflect higher clinical suspicion for rejection or incomplete capture of rejection events in EMR data."

Journal • Infectious Disease • Transplantation

Impact of Induction Therapy on Preventing Early Acute Kidney Allograft Rejection: A Single-Center Experience Study. (PubMed, J Clin Pract Res) - "Acute rejection within two weeks post-transplantation has been associated with suboptimal graft function in recipients with low immunological risk. Basiliximab does not provide additional advantages in preventing early acute rejection in patients with a low immunological risk on tacrolimus-based immunosuppression."

Journal • Nephrology • Transplant Rejection • Transplantation

The Comparison between Chimeric Mouse-Human and Humanized Anti-CD25 Monoclonal Antibody for Steroid-Refractory Acute Graft-Versus-Host Disease (ASH 2024) - "There were 27 (84%) and 36 (80%) patients (p=0.85) who used combined therapy for SR-aGVHD in the xenopax and basiliximab cohorts (mesenchymal stem cells, 63% vs 78%, ruxolitinib, 41% vs 20%, remicade, 6% vs 13%)...While the 1-year overall survival (OS) and relapse-free survival (RFS) from anti-CD25 monoclonal antibody were 63% vs 49% (p=0.13) and 51% vs 49% (p=0.42) in the xenopax and basiliximab cohorts. Conclusions According to this study, the efficacy and adverse events did not differ between the chimeric mouse-human and humanized anti-CD25 monoclonal antibody for SR-aGVHD, and larger study cohorts are needed to confirm our observations."

Preclinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Graft versus Host Disease • Hematological Disorders • Immunology • Infectious Disease • Pneumonia • Respiratory Diseases

A Case of Decompensated Cirrhosis Secondary to Sickle Cell Hepatopathy (SCH) Managed With Orthotopic Liver Transplantation (OLT) Followed by Haploidentical Hematopoietic Stem Cell Transplantation (HSCT) (ACG 2025) - "Despite treatment of SCD with transfusions and hydroxyurea, his cirrhosis progressed with refractory ascites, spontaneous bacterial peritonitis, and hepatic encephalopathy. With a MELD score of 36, he underwent successful OLT with the institution's immunosuppression protocol of basiliximab induction, steroid taper, mycophenolate modafinil and maintenance tacrolimus...Complications included cutaneous reaction to ampicillin requiring IV methylprednisolone and ruxolitinib due to initial concern for early GVHD which was later felt less likely based on timing and presentation characteristics. Sirolimus, used for immunosuppression/GVHD prophylaxis, was switched to tacrolimus due to possible cutaneous adverse reaction and was continued to prevent OLT rejection...Patients with SCD who have undergone liver transplantation can have significant risk of graft loss, with studies showing up to 22% requiring re-transplantation due to SCD complications. Our approach addresses both..."

Clinical • Bone Marrow Transplantation • CNS Disorders • Fibrosis • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Hepatic Encephalopathy • Hepatology • Immunology • Liver Cirrhosis • Sickle Cell Disease • Transplantation

Combined Cytokine Blocking Therapy (CCBT) Using Basiliximab and Infliximab for Treatment of Steroid-Refractory Graft Versus Host Disease (SR-GvHD) (ASH 2023) - "Tacrolimus, sirolimus and cyclosporine dosing and monitoring were performed in accordance with institutional policies. The observed ORR is reflective of both advanced and highly refractory aGVHD with one-third of patients progressing on ruxolitinib. Given the favorable observed ORR in this difficult to treat population, CCBT is a potentially promising approach and suitable alternative in the second line or as salvage therapy in patients failing Ruxolitinib."

Acute Graft versus Host Disease • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • IL2

Targeting of CD25+ Activated T Cells in Gvhd-Associated Marrow Suppression and Cytopenias (ASH 2023) - "We describe 3 cases of GVHD-associated cytopenias marked by HSPC depletion and presence of CD25 (IL-2R alpha subunit)-positive activated T cells in the marrow that responded to combinations of immunosuppression containing basiliximab (basil) anti-CD25 monoclonal antibody blockade...P1 received prednisone, CNI, and rituximab for a presumed anti-HSPC autoantibody...P3 has received prednisone, CNI, and sirolimus indefinitely for prevention of liver rejection and/or hepatocellular carcinoma relapse... We describe combined HSPC and T cell analyses in 3 patients (P) with severe GVHD-associated cytopenias. P1 was at 5 years post-HCT for acute lymphoblastic leukemia, P2 at 2 years post-HCT for severe aplastic anemia (SAA), and P3 at 1. 5 months post-liver transplant for alcohol use disorder-associated cirrhosis and hepatocellular carcinoma ( Table 1)."

IO biomarker • Acute Lymphocytic Leukemia • Addiction (Opioid and Alcohol) • Anemia • Aplastic Anemia • B Cell Lymphoma • Chronic Kidney Disease • Fibrosis • Gastrointestinal Cancer • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Hepatocellular Cancer • Hepatology • Immunology • Infectious Disease • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Pneumonia • Respiratory Diseases • Solid Tumor • Thrombocytopenia • CD34 • CD69 • IL2RA

Chimeric Antigen-Receptor (CAR)-Engineered Natural Killer (NK) Cells Targeting Chronic Myeloid Leukemia (CML) Blast Crisis (ASH 2023) - "Here we show the experimental development of a third-generation CAR-NK therapy strategy against the CD25 based on the scFV of the clinically approved monoclonal humanized antibody, Basiliximab... We show here for the first time the potential use of an NK cell-mediated CAR therapy strategy targeting CD25 which has been shown to be upregulated in CML blast crisis. The experimental data show a significantly increased and selective in vitro and in vivo cytotoxicity of CD25 CAR-NK92 cells against CD25-expressing leukemia cells as compared to WT-NK92 cells. These results suggest that targeting CD25 by a CD25 CAR based on Basilixiamb's scFV might be an interesting tool in BC-CML and in all acute leukemias overexpressing CD25."

IO biomarker • Chronic Myeloid Leukemia • Hematological Malignancies • Leukemia • Oncology • ANXA5 • GZMB • IFNG • IL2RA • LAMP1 • TIGIT

Long-Term Outcome of a Unique Haploidentical High-Dose Peripheral Stem Cell Transplantation Protocol for Hematologic Malignancies: A Prospective Single-Center Study (ASH 2023) - "Background Although many reports have established the efficacy of post-transplantation cyclophosphamide (PTCy) or ATG for GVHD prophylaxis to in vitro non-T cell-depleted (non-TCD) haplo-HSCT and achieved a good clinical effect, the overall results of NRM, RI, DFS, and OS still need to be improved, especially for patients with high-risk or R/R hematologic malignancies...Our haplo-HDPSCT protocol was designed adopting high-dose in vitro non-TCD PBSCs as graft, Ara-C+Bu/Cy+rATG as the conditioning regimen, and Basiliximab plus short-term low-dose GCs added to standard GVHD prophylaxis...Only two patients in the haplo-HDPSCT group developed PTLD. Conclusions This study demonstrates that aGVHD is not high in our haplo-HDPSCT protocol and the long-term follow-up shows that this protocol may bring benefits including high engraftment rate, less relapse and viral infection, which implies that higher doses of in vitro non-TCD PBSCs as a graft source for haplo-HSCT protocol is..."

Clinical • Acute Graft versus Host Disease • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • Oncology • Transplantation • CD34

Chimeric Antigen Receptor T-Cell Therapy in Elderly Patients with Relapsed or Refractory Large B-Cell Lymphoma: A Multicenter Study (ASH 2023) - "The median number of prior lines of therapy was 2 (range 1–8), and 99 (48%) pts had ≥3 prior lines of therapy, 45 (22%) had prior bendamustine, and 44 (21%) had prior stem cell transplant (SCT; auto-SCT, n=41; allo-SCT, n=2; both auto- and allo-SCT, n=1). Bridging therapy was given to 100 (52%) pts; among those, 57 had chemotherapy, 20 had radiotherapy, 6 had both chemotherapy and radiotherapy, 10 had lenalidomide-based regimen, and 7 had CD20 antibody and/or corticosteroids. Axicabtagene ciloleucel (axi-cel) was most frequently used (63%, n=131), followed by lisocabtagene maraleucel (liso-cel) (24%, n=49) and tisagenlecleucel (tisa-cel) (13%, n=27)...The management of CRS and ICANS included corticosteroids in 101 (49%) pts, tocilizumab in 116 (56%) pts, and other biologic agents (anakinra, siltuximab, basiliximab) in 8 (4%) pts... In this large multicenter study of elderly pts with RR LBCL, CART therapy demonstrated favorable efficacy and safety profile comparable to..."

CAR T-Cell Therapy • Clinical • B Cell Lymphoma • Hematological Malignancies • High-grade B-cell lymphoma • Infectious Disease • Large B Cell Lymphoma • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology

Biopsy-Proven Thrombotic Angiopathy Early After Kidney Transplantation: Insights from a Single-Center Series (KIDNEY WEEK 2025) - "80% received Anti Thymocyte Globulin and 20% Basiliximab induction...Patients who lost their graft had a statistically significant higher Banff i-score, cg score, ct score and ci score (p <0.05) at the time of TMA diagnosis. Conclusion TMA is not common in our KTR but kidneys from donors with higher risk such as, chronic changes on biopsies, DCD donors, high KDPI scores and CIT time might be more susceptible to ischemia/reperfusion injury and development of TMA."

Biopsy • Clinical • Antibody-mediated Rejection • Cardiovascular • Fibrosis • Immunology • Reperfusion Injury • Transplantation

Kidney Transplantation in Patients with Obesity and ESRD After Bariatric Surgery: A Case Series (KIDNEY WEEK 2025) - "All received Basiliximab induction followed by Tacrolimus, MMF and prednisolone...(3) Patient 3 struggled to eat and lost weight post-transplant, MMF might have contributed. (4) None developed AKI due to hypovolemia."

Bariatric surgery • Clinical • Surgery • Chronic Kidney Disease • Cognitive Disorders • Focal Segmental Glomerulosclerosis • Gastrointestinal Disorder • Genetic Disorders • Glomerulonephritis • Infectious Disease • Nephrology • Obesity • Renal Disease • Transplantation

Incidence Rate of Catheter-Related Bloodstream Infection After Solid-Organ Transplant: A Single-Center Experience (KIDNEY WEEK 2025) - "None of the heart or liver transplant recipients received antibody induction therapy while 8 lung recipients received basiliximab induction, and 4 received no induction therapy. 97% of the patients received mycophenolate mofetil, tacrolimus, and prednisone, while 3% received steroid-free maintenance...No deaths were attributed to CRBSI. Conclusion Our findings suggest that immunosuppression in the setting of SOT is not associated with an increased risk of CRBSI in patients with renal failure utilizing TDCs especially when a consistent and standardized protocol for the access and care of these catheters is utilized."

Clinical • Infectious Disease • Renal Disease • Solid Organ Transplantation • Transplantation

Association of Donor-Derived Cell-Free DNA and Peripheral Blood Mononuclear Cells (PBMC) Gene Expression Profile with Graft Function Early After Kidney Transplant (KIDNEY WEEK 2025) - "The majority of patients received Alemtuzumab (26) for induction; others received rATG (4) or Basiliximab (5)...Conclusion Our preliminary results suggest that dd-cfDNA and GEP are not associated with early graft function or injury. dd-cfDNA levels decline to baseline as early as 7-days posttransplant, supporting its potential utility for rejection screening beginning the 1 st week post-transplant."

Cell-free DNA • Gene expression profiling • Transplantation

Refractory Clostridium difficile Infection and Simultaneous Cytomegalovirus Activation in a Post-Kidney Transplant Patient: Diagnostic Challenge and Utility of Fecal Microbiota Transplantation (KIDNEY WEEK 2025) - "He was considered at intermediate risk for CMV (both recipient and donor were CMV IgG positive) and had received basiliximab induction therapy followed by maintenance Mycophenolic acid and Tacrolimus, with documented adequate therapeutic serum levels...Despite oral vancomycin and IV metronidazole, symptoms persisted. Repeat colonoscopy showed CMV colitis by IHC (PCR negative) and IV ganciclovir was initiated...Recent evidence suggests FMT utility in CMV colitis, mainly in pediatric IBD. Our case demonstrates successful FMT for refractory CDI and concurrent CMV colitis in a kidney transplant recipient, adding to the scarce evidence in this population."

Clinical • Cytomegalovirus Infection • Gastroenterology • Gastrointestinal Disorder • Immunology • Infectious Disease • Pediatrics • Transplant Rejection • Transplantation

Persistent BK Viremia Leads to BK Virus Nephropathy-Associated Graft Failure in a Simultaneous Liver-Kidney (SLK) Transplant Recipient on Ustekinumab (KIDNEY WEEK 2025) - "Case Description A 70-year-old male with severe Crohn’s disease on ustekinumab, cryptogenic cirrhosis, and ESRD due to HRS underwent SLK transplant.Induction included basiliximab, and maintenance immunosuppression consisted of mycophenolate mofetil(MMF), tacrolimus, and prednisone. BKV load declined following Ustekinumab withdrawal and rebounded upon reintroduction due to relapse, suggesting impaired viral clearance associated with IL-12/23 inhibition. This case highlights the clinical conundrum of using IL-12/23 inhibitors to maintain Crohn's remission without compromising graft function amid ongoing BK replication."

Clinical • Chronic Kidney Disease • Crohn's disease • Fibrosis • Gastroenterology • Hepatology • Immunology • Inflammatory Bowel Disease • Solid Organ Transplantation • Transplantation • IL12A