Jingfei (felzartamab) / TJ Biopharma, Novartis, Biogen - LARVOL DELTA

Not all anti-CD38 antibodies are created equal: The epitope of felzartamab is partially DTT-resistant. (PubMed, Transfus Med) - "Not all epitopes of anti-CD38 antibodies are fully DTT-sensitive. This has important implications for handling of anti-CD38 antibody induced interference in immunohematology, and raises the question of whether DTT is an adequate solution for interference mitigation."

Journal • Hematological Disorders

Prolonged CD38 targeting with felzartamab achieves sustained suppression of antibody-mediated rejection in kidney transplant recipients: a biomarker-guided open-label phase 2 extension (TTS 2026) - P2 | "Prolonged CD38 targeting suppressed molecular and morphologic AMR activity, consistent with a model in which AMR is a chronic, NK-cell–mediated process requiring ongoing immunomodulation. Biomarker-guided dosing using dd-cfDNA was feasible and resulted in variable maintenance dose requirements. Larger controlled trials are required to define optimal dosing and long-term clinical benefit."

Biomarker • Clinical • IO biomarker • P2 data • Antibody-mediated Rejection • Immunology • Inflammation • Transplantation • CXCL10 • CXCL9

Biogen Corporate Breakfast Symposium on Microvascular inflammation: A defining characteristic of antibody mediated rejection in kidney transplantation (TTS 2026) - "We examine clinical evidence supporting this approach, including data from the Phase 2 felzartamab study and subsequent open-label extension evaluating the effects of targeting CD38 on AMR activity, biomarkers, and molecular features of disease over time...Date of preparation: July 2026."

IO biomarker • Antibody-mediated Rejection • Inflammation • Transplantation

Clinical outcomes of the use of subcutaneous daratumumab for donor-derived cell-free DNA guided treatment of antibody mediated rejection in asian kidney transplant recipients at the Singapore General Hospital (TTS 2026) - "Introduction: Long-term kidney transplant (KTX) survival following treatment of antibody mediated rejection (ABMR) with standard of care therapies like plasmaphresis, intravenous immunoglobulin and rituximab remains poor...In recent years, anti-CD38+ therapies have gained interest especially following a randomized controlled trial showing that Felzartamab resolved ABMR in 80% of cases... Our preliminary experience with DARA treatment for ABMR is positive since all experienced a decline in dd-cfDNA but is limited by the lack of follow-up biopsies in most patients."

cfDNA • Clinical • Clinical data • IO biomarker • Antibody-mediated Rejection • Cardiovascular • Immunology • Inflammation • Transplantation

TJ Biopharma and Biogen…announced that felzartamab for injection (trade name: Jingfei, hereinafter referred to as “felzartamab“) has been approved for marketing by the National Medical Products Administration (NMPA) of China for use in combination with lenalidomide and dexamethasone in the treatment of adult patients with multiple myeloma who have received at least one prior line of therapy (Tianjing Biopharma Press Release)

China approval • Multiple Myeloma

GRAVITATE: A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old (clinicaltrials.gov) - P2 | N=60 | Recruiting | Sponsor: Biogen | Not yet recruiting ➔ Recruiting

Enrollment open • Endocrine Disorders • Grave’s Disease

Preservation of Humoral Immunity and Response to Vaccination in Patients With IgAN Treated With Felzartamab. (PubMed, Kidney Int Rep) - No abstract available

Journal • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Novel Coronavirus Disease • Renal Disease • Respiratory Diseases • Tetanus

PROMINENT: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Primary Membranous Nephropathy (PMN) (clinicaltrials.gov) - P3 | N=180 | Recruiting | Sponsor: Biogen | Trial completion date: Mar 2029 ➔ Jan 2031 | Trial primary completion date: Dec 2028 ➔ Jan 2030

Trial completion date • Trial primary completion date • Glomerulonephritis • Renal Disease

Prolonged CD38 targeting with felzartamab in antibody-mediated kidney transplant rejection: a biomarker-guided open-label phase 2 extension. (PubMed, Lancet Reg Health Eur) - P2 | "Biogen (unrestricted grant). Insight (in kind dd-cfDNA measurements)."

Biomarker • IO biomarker • Journal • P2 data • Antibody-mediated Rejection • Immunology • Inflammation • Transplant Rejection • Transplantation

A Study to Learn More About the Safety and Effects of Felzartamab in Adults With Lupus Nephritis Aged 18 to 75 Years Old (clinicaltrials.gov) - P1 | N=14 | Completed | Sponsor: HI-Bio, A Biogen Company | Active, not recruiting ➔ Completed

Trial completion • Glomerulonephritis • Immunology • Inflammatory Arthritis • Lupus • Lupus Nephritis • Nephrology

GRAVITATE: A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old (clinicaltrials.gov) - P2 | N=60 | Not yet recruiting | Sponsor: Biogen

New P2 trial • Endocrine Disorders • Grave’s Disease

TRANSCEND LTE: A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) or Microvascular Inflammation (MVI) (TRANSCEND/TRANSPIRE LTE) (clinicaltrials.gov) - P3 | N=201 | Enrolling by invitation | Sponsor: Biogen | N=120 ➔ 201

Enrollment change • Antibody-mediated Rejection • Inflammation • Transplantation

Felzartamab, an Anti-CD38 Antibody, in Late AMR: Efficacy Independent of Prior Rejection History or Therapy (ATC 2026) - P1, P2 | "In total, 11 patients underwent immunoadsorption-based desensitization (n=8) and/or anti-humoral therapy (n=6), the latter including plasmapheresis (n=2), rituximab (n=2), IVIG (n=1), tocilizumab (n=1), clazakizumab (n=2), and/or the C1s monoclonal antibody BIVV009. Five patients had previously participated in AMR trials evaluating clazakizumab (NCT03444103; n=2), imlifidase (NCT03897205; n=1; control), bortezomib (NCT01873157; n=2; placebo), or BIVV009 (NCT02502903; n=1). Felzartamab is able to reverse AMR, even in patients with a long-standing rejection history and different forms of previous rejection treatment."

Clinical • Antibody-mediated Rejection • Inflammation

Efficacy and safety of B-cell directed therapies in IgA nephropathy: A collaborative meta-analysis (ERA 2026) - "Results Results We identified 8 eligible trials evaluating B-cell directed therapies (sibeprenlimab, atacicept, povitacicept, telitacicept, felzartamab) in 1408 participants with IgAN. Conclusion Conclusion In patients with IgA nephropathy at risk of disease progression, B-cell directed therapies reduce proteinuria and stabilise kidney function, without increasing the risk of serious adverse events or infection. These findings support the role of B-cell directed therapies as a foundational disease‑modifying treatment strategy in patients with IgAN at risk of kidney function loss."

Retrospective data • Glomerulonephritis • IgA Nephropathy • Infectious Disease • Renal Disease

Monitoring Anti-CD38 Treatment with Felzartamab in Antibody-Mediated Kidney Allograft Rejection (ATC 2026) - "These results suggest that dd-cfDNA, may serve as a useful biomarker for monitoring early response to felzartamab treatment. More importantly, dd-cfDNA could indicate the recurrence of rejection after treatment cessation in a timely none-invasive manner, which is subject to ongoing investigations."

IO biomarker • Antibody-mediated Rejection • Inflammation • Transplant Rejection • CXCL10 • CXCL9

Transcend and Transpire: Phase 3 and 2 Trials of the Anti-CD38 Antibody Felzartamab in Kidney Transplant Recipients with Antibody-Mediated Rejection or Isolated Microvascular Inflammation (ATC 2026) - P2, P3 | "The Phase 3 TRANSCEND and Phase 2 TRANSPIRE trials will provide insight into the efficacy and safety of felzartamab across broad categories of participants with AMR and isolated MVI, areas of key unmet medical need."

Clinical • P3 data • Antibody-mediated Rejection • Inflammation • Transplantation

Effect of the Anti-CD38 Antibody Felzartamab on Natural Killer Cells (ATC 2026) - "Our results suggest that felzartamab-mediated NK cell depletion may not exclusively depend on ADCC-mediated fratricide. Alternative molecular modulations, including altered FcgRIIIA expression, suggest potential mechanisms that could contribute to circulating NK cell decrease observed ."

IO biomarker • Antibody-mediated Rejection • ANXA5 • CCL3 • CXCL8 • GZMB • IFNG • IL13 • IL2

Effect of Felzartamab on Digital Cytometry Leukocyte Estimates in Biopsies with ABMR (ATC 2026) - P2 | "Digital cytometry confirms that the leukocytes increased in ABMR in kidney transplants (i.e. activated NK cells, activated mast cells, classically activated macrophages, and monocytes) selectively decreased following treatment with felzartamab and relapsed following cessation of treatment. Digital cytometry may be useful as an aid to monitoring the effect of felzartamab therapy in ABMR."

Biopsy • IO biomarker

Establishing a Central Pathology Review Process and Adjudication Framework to Standardize Biopsy-Based Endpoints in Clinical Trials (ATC 2026) - P2, P3 | "Our objective was to establish a centralized pathology adjudication process in clinical trials of felzartamab for AMR and isolated microvascular inflammation (MVI) as the gold standard to ensure consistency for biopsy-based endpoints.* The TRANSCEND (NCT06685757) and TRANSPIRE (NCT07219043) studies will assess felzartamab in AMR and isolated MVI, respectively... This centralized pathology process, using digital pathology and SAS, will provide an efficient, timely, and reliable method for biopsy scoring to facilitate accurate patient identification and primary endpoint evaluation in transplant clinical trials."

Biopsy • Clinical • Review • Antibody-mediated Rejection • Inflammation

Felzartamab for Antibody-Mediated Rejection: A Phase 2 Open-Label Extension Study (ATC 2026) - P2 | "These findings support the sustained efficacy of felzartamab and the potential of maintenance therapy to sustain rejection suppression. This suggests that extended dosing beyond the initial 6-month treatment period may reduce the burden of repeat initial dosing while maintaining AMR control."

Clinical • IO biomarker • Late-breaking abstract • P2 data • Antibody-mediated Rejection • CXCL10 • CXCL9

Prolonged CD38 targeting with felzartamab achieves sustained suppression of antibody-mediated rejection: biomarker-guided open-label phase 2 extension (ERA 2026) - P2 | "Larger controlled trials are required to define optimal dosing and long-term clinical benefit. Image"

Biomarker • Clinical • IO biomarker • P2 data • Antibody-mediated Rejection • Immunology • Inflammation • CXCL10 • CXCL9

Soluble BCMA as a Biomarker of CD38+ Plasma Cell Depletion in Felzartamab-Treated Patients With IgA Nephropathy From the Phase 2 IGNAZ Study (ERA 2026) - No abstract available

Biomarker • Clinical • IO biomarker • P2 data • Glomerulonephritis • IgA Nephropathy • Renal Disease

Investigating the effects of Felzartamab treatment on peripheral blood transcriptomes in patients with chronic antibody-mediated rejection. (ERA 2026) - No abstract available

Clinical • Antibody-mediated Rejection

TRANSCEND: A Study to Learn More About the Effects and Safety of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (clinicaltrials.gov) - P3 | N=132 | Active, not recruiting | Sponsor: Biogen | Recruiting ➔ Active, not recruiting

Enrollment closed • Antibody-mediated Rejection • Transplantation

TRANSCEND LTE: A Study to Learn More About the Long-Term Safety and Effects of Felzartamab Infusions in Adults With Kidney Transplants Who Have Antibody-Mediated Rejection (AMR) (clinicaltrials.gov) - P3 | N=120 | Enrolling by invitation | Sponsor: Biogen | Not yet recruiting ➔ Enrolling by invitation

Enrollment open • Antibody-mediated Rejection • Transplantation