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RecruitingPhase 1

Alnuctamab for Refractory SLE (LATTE Study)

Open-label, 4-Part Study to Investigate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of Alnuctamab (BMS-986349/CC-93269) in Participants With Moderate to Severe Refractory Systemic Lupus Erythematosus

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 60 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

Not stated in the study description — ask the study team about visits and procedures.

Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the safety of alnuctamab and looks for early signs that it helps treat lupus (SLE). It is for adults ages 18–60 with moderate to severe lupus that has not improved with standard treatments.

This study will assess the safety and preliminary efficacy of the bi-specific TCE, alnuctamab (known as BMS-986349, CC-93269, EM901), targeting BCMA in patients with moderate to severe SLE, refractory to standard-of-care treatments.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • You are 18–60 years old.
  • You have a recorded lupus diagnosis that meets the 2019 ACR/EULAR medical guidelines.
  • Past blood tests show ANA at a level of 1:80 or higher, plus at least one other required antibody. These are proteins that can attack your own body.
  • Your lupus has not responded to steroids and at least two medicines that lower immune activity in different ways. These must include a biologic medicine, such as belimumab, or cyclophosphamide. Hydroxychloroquine does not count, and methotrexate and azathioprine count as one drug group.
  • Your lupus must meet the study’s required disease activity scores. You must not have had active lupus affecting the brain or spinal cord in the past year.
  • Only two people whose lupus causes just joint inflammation, rash, or both may join. These symptoms must be truly disabling.

Who can't join

  • You have another disease in which the immune system attacks the body. Related Sjogren’s disease is allowed if it is not the main cause of symptoms. Fibromyalgia is also allowed if it is not the main cause.
  • You have TTP-like lupus or catastrophic APS, serious conditions involving blood clots.
  • You have rapidly worsening lupus kidney disease or a kidney filtering score (eGFR) below 40. Class V lupus kidney disease cannot be the main reason for joining unless you also have class III or IV.
  • You have active brain or spinal cord problems caused by lupus.
  • You have an active or suspected infection, including HIV.
  • Your oxygen level is below 92% without added oxygen, or blood tests show low neutrophils (infection-fighting cells) below 1,500/µL, hemoglobin below 8 g/dL, or platelets below 75,000/µL.
  • Your liver tests show ALT or AST above twice the normal limit, unless caused by active muscle inflammation. Total bilirubin above 1.5 times the normal limit also excludes you, unless caused by Gilbert’s disease.
  • You have fewer than 12 B cells per microliter or an antibody level below 500 mg/dL. B cells and antibodies help fight infections.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Key Inclusion Criteria: * Age 18-60 years. * Documented diagnosis of SLE fulfilling 2019 ACR/EULAR criteria. * Historical documentation of ANA (1:80 or greater) autoantibody on immunofluorescence as well as presence of at least 1 additional autoantibody of the type: anti-dsDNA, anti-histone, anti-chromatin, anti-Smith, anti-RNP, anti-Ro/SSA, anti-La/SSB, anti-cardiolipin (IgG), or anti-beta2-glycoprotein1 (IgG). * History of SLE that is refractory to corticosteroids and at least 2 immunosuppressive therapies with different mechanisms of action (methotrexate, thiopurines, mycophenolate mofetil, calcineurin inhibitors, biologic agents, cyclophosphamide), including at least one biologic therapy (e.g. anti-CD20 therapy, anifrolumab, belimumab) or cyclophosphamide. Of note, hydroxychloroquine is not considered an immunosuppressive therapy, and methotrexate/azathioprine counts as a single drug class). * Total SLEDAI-2K \>6 with clinical SLEDAI-2K \>4, or \>1 BILAG A organ domain score, or \>2 BILAG B, but without active central nervous system (CNS) disease within the past year; a maximum of two participants with only arthritis and/or rash can be included if truly disabling Key Exclusion Criteria: * Autoimmune disease other than SLE, except associated Sjogren's Disease if not primary contributor to symptoms; coexistent fibromyalgia will be allowed if not primary contributor to symptoms. * TTP-like SLE; catastrophic APS; LN WHO class V as primary qualifying criterion (unless overlap with Class III or IV), rapidly progressive LN, or eGFR \<40 mL/min; active CNS pathology attributable to neuropsychiatric SLE. * Active or suspected infection, including HIV. * O2 sat \<92% on room air; ANC \<1500u/L, Hgb \<8g/dL, Plt \<75,000/uL; ALT or AST \> 2X ULN (unless attributed to active myositis), Total Bilirubin \>1.5 X ULN (unless Gilbert's Disease), total B cell count \<12/microliter, hypogammaglobinemia \<500mg/dL.

Study sites (1)

NY