Nulojix (belatacept) / BMS - LARVOL DELTA

Thrombotic Microangiopathy post Simultaneous Pancreas-Kidney (SPK) transplant: a challenging scenario (TTS 2026) - "Management strategies vary and may include withdrawal of CNI therapy, plasma exchange or complement inhibition with drugs like eculizumab...She received induction immunosuppression with anti-thymocyte globulin, followed by standard maintenance therapy: prednisolone, tacrolimus, and mycophenolate mofetil (MMF)...Tacrolimus was subsequently replaced with Belatacept. However, CMV reactivated, necessitating a switch to an mTOR inhibitor (everolimus). Due to concerns for maribavir resistance, valganciclovir was restarted... Delayed post-transplant TMA may be multi-factorial, with contributions from CNI toxicity, viral infections, and genetic mutations. This case highlights the importance of dynamic immunosuppression adjustment and infection management. Ongoing management requires careful balancing of rejection risk and infectious complications, with complement inhibition considered for recurrent or refractory TMA."

Antibody-mediated Rejection • Beta-Thalassemia • Diabetes • Diabetic Nephropathy • Genetic Disorders • Gynecology • Hematological Disorders • Infectious Disease • Metabolic Disorders • Neutropenia • Transplantation • Type 1 Diabetes Mellitus

Re-engineering CD154 blockade for transplantation: Fc-free design to separate thrombotic risk from therapeutic function. (PubMed, Clin Transplant Res) - "Size-based carriers recover only the second: conjugation of polyethylene glycol (PEG) to an anti-CD154 Fab' extends its half-life from hours to weeks, as in dapirolizumab pegol, but leaves FcRn recycling unaddressed, while uncertainties remain regarding long-term PEG exposure. Albumin recovers both through FcRn-dependent recycling and its own molecular size, without engaging Fcγ receptors. Dazodalibep, an Fc-free albumin-fusion CD154 antagonist, was administered with belatacept to kidney transplant recipients in a single-arm phase 2a trial without thrombotic events, but the prespecified composite efficacy endpoint was not met."

Journal • Review • Cardiovascular • Transplant Rejection • Transplantation • CD40 • CD40LG

Comparison of Outcomes Between Obese and Non-Obese Pancreas Transplant Recipients Following Belatacept Conversion. (PubMed, Transplant Proc) - "All patients had an improvement in HbA1c post-pancreas transplant; however, there were more patients requiring insulin in the obese group. Acute rejection, de novo DSA development, GFR and HbA1c 6-months post-conversion, and infectious complications were similar between the groups. Larger studies are warranted to assess the safety and efficacy of belatacept use post-pancreas transplantation."

Journal • Diabetes • Metabolic Disorders • Obesity • Transplant Rejection • Transplantation

Immune cell and serum cytokine dynamics in islet transplant recipients receiving Belatacept/Sirolimus versus Tacrolimus/Mycophenolate (TTS 2026) - "Bela/Siro promotes early enrichment of regulatory immune subsets, including Tregs, pDCs and Breg-like cells, with distinct CD8+T-cell and innate immune recovery patterns, while maintaining comparable systemic cytokine profiles. These immunoregulatory features may contribute to improved transplant outcomes."

Clinical • Immune cell • Transplantation • B3GAT1 • CD27 • CD8 • FOXP3 • GZMA • IFNG • IL10 • IL17A • IL2 • IL4 • IL6 • TNFA

LEA29Y expression executes a heterogenous protective effect on cardiac transplants in a porcine allograft model (TTS 2026) - "Pre-existing immune activation may serve as a strong predictive marker for post-transplant rejection responses. Retrospective single nuclei RNAseq analysis will give detailed insight into the underlying mechanisms of immune response pre-disposition and help to determine synergistic angles to support local T-cell co-stimulation blockade."

Preclinical • Immunology • Transplant Rejection • Transplantation • ADAM17 • CD68 • HLA-DRB1 • IFNG • IL10 • IL18 • IL1A • IL1B • IL6 • MYH7 • PTPRC • RYR2 • TNFA

A multi-centre study of Belatacept and Sirolimus for human islet transplantation (TTS 2026) - "They were compared to a contemporaneous cohort of recipients treated with tacrolimus/mycophenolate mofetil (tac/MMF). The proportion of FOXP3+ regulatory T cell, memory-like Treg, transitional activated memory CD8+ T cells, and atypical class-switched memory B-cells were significantly higher in the Bela/siro group. Baseline immunosuppression with Bela/siro facilitated early islet engraftment and improved rates of insulin independence, as well as less impact on renal function, supporting the rationale for routine use in islet transplantation."

Clinical • Diabetes • Hypoglycemia • Metabolic Disorders • Solid Organ Transplantation • Transplantation • Type 1 Diabetes Mellitus • CD8 • FOXP3

LEA29Y pigs facilitate a local break down of remodelling processes in post-ischemic myocardial scar formation under immunosuppression (TTS 2026) - "Immune modulation influenced both the timing and pattern of remodelling, leading to slower but more sustained recovery of ejection fraction in LEA29Y pigs. Proteomics and snRNA-seq support the suggestion of a delayed and reduced remodelling under immunosuppression, co-inciding with a more pronounced macrophage clustering in infarcted areas. The quantitative histological protocols established here have the capacity to clarify spatio-temporal immuno-modulatory processes also in the examination of graft rejection or tolerance."

Cardiovascular • Immune Modulation • Immunology • Reperfusion Injury • Transplant Rejection

Long term outcomes with Belatacept use in pancreas transplantation (TTS 2026) - "34 patients (EBV+) received Belatacept (2 de novo and 32 conversions) due to severe kidney dysfunction with chronic histological damage (5), CNI toxicity (15), pancreas dysfunction (4), AMR or DSA Ab (8), high cardiovascular risk (1) and a partial pancreas (1). Tacrolimus was minimized in 16 cases and discontinued in 18. Table 1 Reasons for Belatacept use With a mean f/u of 83mo, there were 17 rejection episodes (5Kid, 8Pan, 4KP) at 43mo (5-100)."

Cardiovascular • CNS Disorders • Diabetic Nephropathy • Gastrointestinal Disorder • Infectious Disease • Nephrology • Novel Coronavirus Disease • Transplantation

Flow cytometry immune profiling provides early detection of rejection of islet xenotransplants (TTS 2026) - "All recipients received anti-CD2 induction and maintenance with anti-CD154 and Belatacept... This study demonstrates reliable flow cytometry for assessing immune status in xeno-islet recipients and the potential to predict and prevent early graft rejection."

Diabetes • Inflammation • Metabolic Disorders • Transplant Rejection • Transplantation • Type 1 Diabetes Mellitus • CD40LG • CD8

Targeting Innate Allorecognition Via CD47-Sirpa Prolongs Cardiac Allograft Survival In Presensitized Recipients (TTS 2026) - "More specific therapeutic strategies, such as CTLA4-Ig (belatacept) with long-term benefits exist; however, they cause higher acute rejection rates without the addition of calcineurin inhibitors (CNI)... Disrupting innate allorecognition is a promising target and can be combined with costimulatory blockade to achieve CNI-free immunosuppression and long-term graft survival. Further studies will determine how CD47 signaling drives monocyte differentiation and directs cytokine production."

Cardiovascular • Transplant Rejection • CD8 • IFNG • IL10 • IL12A • SIRPA

Belatacept use in paediatric renal transplant patients in an Australian tertiary paediatric centre (TTS 2026) - "This case series shows the use of belatacept in children in a tertiary children's hospital in Australia. The patients in this study have different indications for the use of belatacept and different demographics. No adverse events were noted, and all patients demonstrated a positive treatment response."

Clinical • Infectious Disease • Pediatrics • Transplantation

Belatacept (TTS 2026) - No abstract available

Pediatrics

Abatacept Conversion in Kidney Transplantation (clinicaltrials.gov) - P2 | N=87 | Completed | Sponsor: Emory University | Active, not recruiting ➔ Completed

Head-to-Head • Trial completion • Transplantation

Belatacept and the Risk of Cytomegalovirus, BK Polyomavirus, and Epstein-Barr Virus Post-transplant Lymphoproliferative Disease After Kidney Transplantation: A Meta-Analysis and Systematic Review. (PubMed, J Transplant) - "The risk of CMV and BK polyomavirus infections may also be increased with real-world belatacept use. However, these observations should be interpreted with consideration for the inherent limitations of NRTs."

Journal • Retrospective data • Review • Cytomegalovirus Infection • Epstein-Barr Virus Infections • Infectious Disease • Transplantation

Hepatic Immunomodulatory Effect of Belatacept on the TNF-?/IL-6 Pro-Inflammatory Axis and its Impact on Regulation of Mirna-146a in Hepatic Injury. (PubMed, Med Princ Pract) - "These findings show that belatacept has stronger immunomodulatory action when compared with standard therapy. Belatacept is a promising new treatment option for liver-driven systemic inflammation which acts by inhibiting the TNF-α/IL-6 axis and modulating miRNA-146a."

Journal • Hepatology • Liver Failure • Oncology • IL6 • TNFA

Sequential antibody induction for immune tolerance in clinical organ transplantation: a feasibility review of immunosuppressant withdrawal protocols. (PubMed, Front Immunol) - "Sequential antibody induction protocols - using peri-transplant antibodies (e.g., alemtuzumab, anti-thymocyte globulin, belatacept, anti-CD40 monoclonal antibodies) combined with phased reduction or withdrawal of maintenance drugs - aim to establish "operational tolerance" or complete tolerance. Our multidimensional feasibility assessment - covering cost, complexity, risk-benefit, patient selection, and regulatory barriers - indicates that costimulation-blockade protocols currently offer the best balance for near-term clinical use, whereas chimerism approaches are the most effective but remain restricted to specialised centres. Future work should integrate precise immune stratification, advanced antibody engineering, and cell-based therapies to facilitate individualized sequential protocols, ultimately moving the field from lifelong immunosuppression to controlled immune tolerance."

Journal • Review • Infectious Disease • Metabolic Disorders • Oncology • Solid Organ Transplantation • Transplant Rejection • Transplantation

Study on the Antirejection Effects of the Dual ICOS and CD28 Antagonist Acazicolcept (ALPN-101) in Mouse Skin and Heart Transplantation Models. (PubMed, Transplantation) - "Acazicolcept exhibits robust, superior antirejection efficacy compared with single-pathway blockades by concurrently inhibiting CD28 and ICOS signals. This dual mechanism effectively suppresses T-cell activation, effector memory differentiation, and the subsequent antibody-mediated response, offering a robust preclinical justification for its clinical advancement in solid organ transplantation."

IO biomarker • Journal • Preclinical • Solid Organ Transplantation • Transplantation • CD28 • CD69 • ICOS • PD-1

Belatacept: Better Outcomes, no Cancer Signal, but Limited Global Access. (PubMed, Transplantation) - No abstract available

Journal • Oncology

Belatacept For Immunosuppression Optimization In Heart Transplantation: A Case Of Improved Adherence And Donor-derived Cell-Free DNA Reduction [Poster no. 179] (HFSA 2026) - No abstract available

Adherence • cfDNA • Clinical • Transplantation

Immunosuppression in vascularized composite allotransplantation. (PubMed, Curr Opin Organ Transplant) - "Tacrolimus-based triple therapy remains the clinical standard, with its concomitant nephrotoxicity requiring kidney transplantation after face and hand transplantation in some cases. Costimulation blockade-based, calcineurin inhibitor-sparing protocols represent an advanced path toward safer VCA immunosuppression."

Journal • Review • Cardiovascular • Solid Organ Transplantation • Transplantation • CD40LG

Clinical Challenges in Managing Ganciclovir-Resistant CMV Ileitis (ACG 2026) - "Case Description/ A 63-year-old male with type 1 diabetes mellitus and end-stage renal disease status post deceased donor renal transplantation (CMV D+/Râ) two months prior, on mycophenolate 720 mg twice daily and Belatacept 5mg/kg every 28 days presented to the emergency department with seven episodes of non-bloody diarrhea...Diarrhea improved after treatment with Maribavir and immunosuppression was resumed...UL54 encodes the catalytic subunit of viral DNA polymerase conferring resistance to ganciclovir as well as foscarnet and cidofovir...This case highlights the clinical course of a patient with CMV in a notably uncommon location, the terminal ileum. Figure: A. Endoscopic images of terminal ileum showing ulcers due to CMV Ileitis."

Clinical • Cytomegalovirus Infection • Diabetes • Gastroenterology • Gastrointestinal Disorder • Immunology • Metabolic Disorders • Nephrology • Renal Disease • Type 1 Diabetes Mellitus

Cancer Risk in Kidney Transplant Recipients on Belatacept Versus Calcineurin Inhibitors: A Systematic Review and Meta-Analysis. (PubMed, Transplantation) - "Overall, belatacept-based immunosuppression was not associated with a significantly increased risk of skin or other cancers compared with CNI-based regimens. Larger, adequately powered studies with cancer outcomes as primary endpoints are needed to better define cancer risk associated with belatacept conversion in kidney transplant recipients."

Journal • Retrospective data • Cardiovascular • Genetic Disorders • Oncology • Skin Cancer • Transplantation

Pregnancy Outcomes After Belatacept Exposure in Solid Organ Transplant Recipients: A Scoping Review. (PubMed, Healthcare (Basel)) - "Because no comparative studies were available, maternal and neonatal outcomes cannot be assumed equivalent to those of conventional immunosuppression. Belatacept cannot be recommended for routine use during pregnancy; clinical decisions must remain individualized, and preconception counseling and prospective multicenter registries are urgently needed."

Journal • Review • Acute Kidney Injury • Cytomegalovirus Infection • Diabetes • Gestational Diabetes • Gynecology • Metabolic Disorders • Nephrology • Solid Organ Transplantation • Transplantation

A multi-centre study of belatacept and sirolimus for islet transplantation. (PubMed, Diabetologia) - P2 | "Baseline immunosuppression with bela/siro facilitated early islet engraftment and rates of insulin independence, with less impact on renal function, supporting the rationale for routine use in islet transplantation."

Journal • Diabetes • Hypoglycemia • Metabolic Disorders • Renal Disease • Solid Organ Transplantation • Transplant Rejection • Transplantation • Type 1 Diabetes Mellitus • CD4 • FOXP3

Cytomegalovirus viremia associated with systemic thrombotic microangiopathy after kidney transplantation: a case report. (PubMed, Front Med (Lausanne)) - "Intravenous ganciclovir therapy was initiated and later transitioned to oral valganciclovir...Immunosuppression was subsequently reintroduced using a calcineurin inhibitor-free regimen with belatacept. CMV infection should be considered a plausible trigger of de novo post-transplant thrombotic microangiopathy, particularly in patients with persistent disease despite withdrawal of calcineurin inhibitors. Although post-transplant TMA is frequently multifactorial, early recognition of CMV viremia and timely comprehensive management addressing all contributing factors may be associated with favorable hematologic recovery and improvement of graft function."

Journal • Cytomegalovirus Infection • Gastrointestinal Disorder • Hematological Disorders • Immunology • Infectious Disease • Thrombocytopenia • Transplantation