Campath (alemtuzumab) / Bayer, Sanofi - LARVOL DELTA

SCDHCT: Reduced Intensity Transplantation for Severe Sickle Cell Disease (clinicaltrials.gov) - P2 | N=46 | Active, not recruiting | Sponsor: St. Jude Children's Research Hospital | Suspended ➔ Active, not recruiting

Enrollment closed • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • Transplantation

Physician Understanding and Perceptions of Risk Communication Related to Drugs Covered by Risk Evaluation and Mitigation Strategy Programs. (PubMed, Pharmacoepidemiol Drug Saf) - "While physicians largely expressed awareness of REMS testing requirements and found REMS programs to be valuable sources of risk communication, they would like more information on managing side effects, more accessible information on REMS requirements, integration of REMS programs with EMRs, and timely updates to REMS materials as new safety information emerges."

Journal

Phase 1B pilot study of itacitinib with alemtuzumab in patients with T-cell prolymphocytic leukemia. (PubMed, Blood Neoplasia) - P1 | "Continued studies evaluating JAK inhibitors in patients with T-PLL are warranted. This trial was registered at www.clinicaltrials.gov as #NCT03989466."

Clinical • Journal • P1 data • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • Transplantation • IL2RG • JAK3 • STAT5B • TCL1A

Conditioning Intensity and Outcomes in Pediatric HLA-Identical Transplant for Sickle Cell Disease: Comparison of MAC, RIC, and NMA. (PubMed, Transplant Cell Ther) - P2 | "NMA conditioning with alemtuzumab and low-dose TBI substantially reduces toxicity compared with MAC and RIC. Although some patients require second HCT to improve donor engraftment, overall outcomes support this NMA approach as an option for children and adolescents with SCD."

Journal • Chronic Graft versus Host Disease • Genetic Disorders • Graft versus Host Disease • Hematological Disorders • Immunology • Pediatrics • Sickle Cell Disease • Transplantation

Improving the Results of Bone Marrow Transplantation for Patients With Severe Congenital Anemias (clinicaltrials.gov) - P1/2 | N=130 | Active, not recruiting | Sponsor: National Heart, Lung, and Blood Institute (NHLBI) | Trial completion date: Jan 2026 ➔ Jan 2028

Trial completion date • Anemia • Beta-Thalassemia • Bone Marrow Transplantation • Genetic Disorders • Hematological Disorders • Sickle Cell Disease • Transplantation

Standard-of-Care-Informed Unsupervised Learning and Multi-Biomarker Modeling for Diagnosis of Kidney Transplant Rejection (TTS 2026) - P=N/A | " The k=3 clusters separated clinically distinct profiles: deceased-donor/ATG-induction (n=111), longer-time/living-donor/alemtuzumab (n=226), and early-post-transplant/female/high-TTV (n=123)... SOC-informed clustering with cluster-specific multi-biomarker classifiers enables personalized rejection surveillance, while preserving AMR discrimination. This framework addresses the key clinical challenge of optimally integrating multiple biomarkers while tailoring decisions to patient context, and reducing dependence on biopsy. Phenotype-wise Diagnostic Performance Comparison between supervised and unsupervised models."

Biomarker • Immunology • Infectious Disease • Nephrology • Transplant Rejection • Transplantation • CXCL10 • CXCL9

Alemtuzumab or basiliximab: Rethinking induction choice beyond acute rejection in kidney transplantation. (PubMed, World J Transplant) - "These findings highlight a central paradox in transplant immunology: Strategies that achieve potent early immune suppression may incur delayed biological costs related to immune reconstitution, impaired immune surveillance, and cumulative graft injury. Collectively, the data argue for a shift away from rejection-centred metrics toward a more proportional and individualised approach to induction selection, in which long-term graft preservation and complication risk are weighed as carefully as early rejection prevention."

Journal • Review • Cytomegalovirus Infection • Oncology • Transplant Rejection • Transplantation

CMV transplant nephritis and graft failure: A cautionary tale (TTS 2026) - "The patient received induction immunosuppression with alemtuzumab...The patient was treated initially with intravenous ganciclovir, briefly switched to foscarnet, and ultimately discharged on oral valganciclovir... CMV nephritis is a rare but serious complication of kidney transplantation associated with high rates of graft failure. This case highlights the importance of maintaining high clinical suspicion for CMV end-organ disease in patients with risk factors such as lymphocyte-depleting induction therapy, even in CMV-seropositive recipients. Early recognition through kidney biopsy and aggressive antiviral treatment are essential, though outcomes remain poor."

Chronic Kidney Disease • Cytomegalovirus Infection • Fibrosis • Focal Segmental Glomerulosclerosis • Gastrointestinal Disorder • Glomerulonephritis • Immunology • Infectious Disease • Nephrology • Transplantation • Vasculitis

Different Induction Strategies in Kidney Transplantation: A Comparative Analysis of Alemtuzumab, Alemtuzumab plus Eculizumab, and Basiliximab (TTS 2026) - "The initial baseline immunosuppressive regimen in all groups consisted of tacrolimus, mycophenolate mofetil, and prednisone. This analysis demonstrates that combination induction therapy with ALEM + ECU provides a good balance between immune response control and infectious safety. This strategy achieves maximal graft survival by significantly reducing the risk of severe infections compared to ALEM, while demonstrating superior efficacy to standard BAS therapy."

Infectious Disease • Transplant Rejection • Transplantation

EBV viremia and PTLD incidence in EBV-negative kidney transplant recipients: Alemtuzumab vs. Basiliximab induction (TTS 2026) - "In high-risk EBV-negative kidney transplant recipients, basiliximab induction was associated with significantly higher rates of EBV viremia compared to alemtuzumab. However, this did not translate into a statistically significant increase in PTLD cases. While induction therapy choice impacts primary EBV viremia rates, progression to PTLD is likely multifactorial."

Clinical • Epstein-Barr Virus Infections • Infectious Disease • Solid Organ Transplantation • Transplantation

Comparison of GvHD prophylaxis regimens based on in vivo T-cell depletion (ATG vs. alemtuzumab) in patients with AML undergoing allo-HCT from unrelated donors with intermediate transplant conditioning intensity protocols: a registry study on behalf of the EBMT acute leukemia working party. (PubMed, Bone Marrow Transplant) - "In summary, for AML patients in complete remission receiving intermediate-intensity conditioning, ATG improved long-term survival and reduced relapse risk compared with alemtuzumab, despite increased acute GvHD. These findings support ATG as an effective GvHD prophylactic option in this setting."

Journal • Preclinical • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Transplantation

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

Response to alemtuzumab-based therapy and long-term survival after allogeneic transplantation in T-Cell prolymphocytic leukemia: a systematic review and meta-analysis of proportions. (PubMed, Eur J Clin Pharmacol) - "Alemtuzumab-based therapy was associated with high response rates in T-PLL-approximately 85% frontline-and approximately one-third of transplanted patients achieved long-term survival. These pooled values are descriptive benchmarks derived from low-certainty, single-arm evidence and require prospective confirmation."

Clinical • Journal • Retrospective data • Review • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • Transplantation

Hospitalization Costs of Kidney Transplantation Associated With Induction Therapy Among Pediatric Kidney Transplant Recipients: A North American Pediatric Renal Trials and Collaborative Studies and Pediatric Health Information System Collaborative Study. (PubMed, Pediatr Transplant) - "Among pediatric and young adult kidney transplant recipients, IHC was comparable across induction agents. Younger age at transplantation and DGF were associated with significantly higher IHC."

Journal • Retrospective data • Pediatrics • Transplantation • IL2

Phase 1 clinical trial of CRISPR-engineered CAR19 universal T cells for treatment of children with refractory B cell leukemia. (PubMed, Sci Transl Med) - P1 | "Three cell banks of TT52CAR19 T cells were generated and cryopreserved...Lymphodepletion included fludarabine, cyclophosphamide, and alemtuzumab and was followed by a single infusion of 0.8 × 10 to 2.0 × 10 CAR19 T cells per kilogram with no immediate toxicities...Other complications were within expectations, and primary safety objectives were met. This study provides a demonstration of the feasibility, safety, and therapeutic potential of CRISPR-engineered immunotherapy."

Clinical • IO biomarker • Journal • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Malignancies • Immunology • Inflammation • Leukemia • Oncology • Transplantation • CD19 • CD52

Incorporation of 8Gy total body irradiation into reduced intensity conditioning does not improve allogeneic transplant outcomes for high-risk adult acute lymphoblastic leukemia: Results from the randomised prospective phase 2 UK multicentre ALL-RIC impact study (ASH 2025) - "We therefore performed a prospective,randomised comparison of the UK FMA RIC regimen with a cyclophosphamide plus 8Gy TBI RIC protocol(Cy/8TBI), with the goal of improving OS in high-risk adult ALL.MethodsThe FMA RIC regimen (fludarabine 30mg/m2 IV for 5d; melphalan 140mg/m2 IV single dose; alemtuzumab 30mg IV D-1 for sibling donor/20mg IV D-2 & -1 for unrelated donor) was compared tocyclophosphamide 50mg/kg for 2d plus 8Gy TBI (4# over 2d) and alemtuzumab (dosed as per FMA).Intrathecal prophylaxis was given for 2y post-SCT. However, incorporation of 8Gy TBI into a RIC protocol designed for older adults was welltolerated, with no increases in acute or chronic GvHD, and no additional infectious or extramedullarytoxicity.These data highlight the importance of performing randomised trials of innovative conditioningregimens, if outcomes for older patients receiving allo-SCT for ALL are to be improved. Importantly theALL-RIC trial showcases feasibility and patient..."

Clinical • P2 data • Acute Graft versus Host Disease • Acute Lymphocytic Leukemia • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Infectious Disease • Leukemia • T Acute Lymphoblastic Leukemia • Transplantation • KMT2A

Universal Base-Edited CAR7 T Cells for T-Cell Acute Lymphoblastic Leukemia. (PubMed, N Engl J Med) - "Universal BE-CAR7 T cells induced leukemic remission in patients with relapsed or refractory T-cell ALL, thus allowing successful allogeneic hematopoietic stem-cell transplantation in most of the patients. (Funded by the Medical Research Council and others; ISRCTN Registry number, ISRCTN15323014.)."

Journal • Acute Lymphocytic Leukemia • Bone Marrow Transplantation • Hematological Disorders • Hematological Malignancies • Infectious Disease • Leukemia • Oncology • Palliative care • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • Transplantation • CD52

Universal base-edited CAR7 T cells for T-cell acute lymphoblastic leukemia (ASH 2025) - "BE-CAR7 T cells were infused afterlymphodepletion (LD) with fludarabine (150 mg per square meter), cyclophosphamide (120 mg/kg) andalemtuzumab (1 mg/kg). As anticipated, viral reactivations were frequent, and three patientsexperienced significant virus-related morbidity post-transplant. Overall, 7/11 (63%) subjects dosed werein ongoing remission 3-36 months after transplant, and suspected CD7 negative leukemic escape hasbeen documented in 2 patients.Conclusions Universal BE-CAR7 T cells offer the prospect of leukemic remission for patients with CD7+ r/rT-ALL ahead of allo-SCT and will be further assessed in children and adults in extended cohorts."

Acute Lymphocytic Leukemia • Bone Marrow Transplantation • CNS Disorders • Dermatology • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • T Acute Lymphoblastic Leukemia • T-cell Acute Lymphoblastic Lymphoma • CD52 • CD7

Ameli-01: A Phase I Trial of UCART123v1.2, an Anti-CD123 Allogeneic CAR-T Cell Product, in Adult Patients with Relapsed or Refractory (R/R) CD123+ Acute Myeloid Leukemia (AML) (ASH 2022) - P1 | "AMELI-01 (NCT04106076) is a phase 1, open-label, dose-escalation trial evaluating the safety, tolerability, expansion, and persistence of UCART123v1.2 given at escalating dose levels after LD with either fludarabine and cyclophosphamide (FC) or FC with alemtuzumab (FCA) in patients (pts) with R/R CD123+ AML...Pts must have received ≥2 cycles of chemotherapy (one with standard dose cytarabine), ≥ 1 cycle of a high/intermediate dose cytarabine containing regimen, ≥ 2 cycles of an HMA combination regimen, or prior allogeneic HSCT... Adding alemtuzumab to the FC regimen was associated with improved LD and significantly higher UCART123v1.2 cell expansion and persistence, which correlated with improved activity and safety, including one pt in the DL2 FCA arm who achieved a durable MRD-negative CR. Overall, these data support the safety and activity of UCART123v1.2 after FCA LD in pts with CD123+ R/R AML."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Inflammation • Leukemia • Oncology • CD123 • IFNG • IL10 • IL15 • IL2 • IL6 • TNFA

UCART19, a first-in-class allogeneic anti-CD19 chimeric antigen receptor T-cell therapy for adults with relapsed or refractory B-cell acute lymphoblastic leukaemia (CALM): a phase 1, dose-escalation trial. (PubMed, Lancet Haematol) - P1 | "UCART19 had a manageable safety profile, and showed evidence of antileukaemic activity in heavily pretreated adult patients with relapsed or refractory B-cell acute lymphoblastic leukaemia. This study shows that allogeneic off-the-shelf CAR T cells can be used safely to treat patients with relapsed B-cell acute lymphoblastic leukaemia."

CAR T-Cell Therapy • Journal • P1 data • Acute Lymphocytic Leukemia • B Acute Lymphoblastic Leukemia • Graft versus Host Disease • Hematological Disorders • Hematological Malignancies • Immunology • Infectious Disease • Inflammation • Leukemia • Oncology

Initial clinical data from the phase 1 study of DR-01, a non-fucosylated anti-CD94 antibody in patients with large granular lymphocytic leukemia (ASH 2025) - P1/2 | "Prior therapies includedmethotrexate in 29 (94%), cyclophosphamide in 15 (48%), cyclosporine in 13 (42%), and alemtuzumab in 4(13%), with 17 (55%) pts also receiving some other treatment including investigational agents. Preliminary safety and efficacy data show that DR-01 is well-tolerated with a promisingresponse rate and durable responses, supporting continued development of DR-01 as a therapy forLGLL."

Clinical data • P1 data • Hematological Malignancies • Infectious Disease • Leukemia • Lymphoma • Neutropenia • CD8 • GZMB • KLRD1

Accelerated desensitization enables HLA-incompatible deceased donor kidney transplant in a highly sensitized pediatric recipient. (PubMed, Hum Immunol) - "Accelerated desensitization over 6 days consisted of three plasmapheresis sessions followed by intravenous immunoglobulin and rituximab. Alemtuzumab was used as induction agent for transplant...At 12 months, mixed T-cell- and antibody-mediated rejection occurred despite stable donor-specific antibodies. Graft function remained stable at 43 mL/min/1.73 m2 at 15 months post-transplant."

Journal • Antibody-mediated Rejection • Pediatrics • Transplantation

First-in-Human Study of IL15-Activated Cytokine-Induced Killer Cells After Allogeneic HCT Shows Durable Remission and Serotherapy-Associated Immune Reconstitution in Leukemia. (PubMed, J Clin Oncol) - P1/2 | "IL15-CIK monotherapy is feasible and safe and demonstrates promising relapse-preventive activity after hematopoietic stem-cell transplantation. Clinical outcomes are strongly influenced by disease burden at treatment initiation and previous serotherapy, supporting optimized patient selection and timing in future post-transplant immunotherapeutic strategies."

First-in-human • Journal • P1 data • Acute Graft versus Host Disease • Acute Myelogenous Leukemia • Bone Marrow Transplantation • Chronic Graft versus Host Disease • Graft versus Host Disease • Hematological Malignancies • Immunology • Leukemia • Oncology • Pediatrics • Transplantation • IL15

Treatment Patterns, Outcomes and Survival Trends in T-Cell Prolymphocytic Leukemia: A Nationwide Population-Based Study in the Netherlands. (PubMed, Eur J Haematol) - "Alemtuzumab followed by alloSCT remains the most effective strategy for fit patients with T-PLL, yet long-term survival is uncommon and has not improved over two decades. High relapse rates and poor salvage outcomes underscore the need for novel targeted and immune-based approaches and optimized post-remission strategies."

Journal • Hematological Malignancies • Leukemia • Oncology • Prolymphocytic Leukemia • Transplantation

Alemtuzumab in relapsed immune severe aplastic anemia: Long-term results of a phase II study. (PubMed, Am J Hematol) - P2 | "Alemtuzumab induces responses in relapsed SAA, some of which are durable long-term. However, immunosuppression can persist for years, requiring long-term monitoring."

Journal • P2 data • Anemia • Aplastic Anemia • Bone Marrow Transplantation • Hematological Disorders • Transplantation