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Closed (no longer recruiting)Last updated: 31 January 2024

CARDINAL: This phase III trial is evaluating an investigational drug (Sutimlimab) in patients with Primary Cold Agglutinin disease, who have recently received a blood transfusionA Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

Clinical summary

Summary

Participants in this trial will receive intravenous sutimlimab in Part A. Participants who complete Part A through to Day 182 (end of treatment) according to the protocol will participate in Part B. Participants in Part B will continue to receive sutimlimab up to one year after last patient out (LPO) in Part A.

Conditions

This trial is treating patients with primary cold agglutinin disease.

Cancer

Blood Cancers Haematological

Age

People18+

Phase

III

Trial Acronym

CARDINAL

More information

Trial Identifiers

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Trial sponsor

Bioverativ Therapeutics Inc.

Scientific Title

A Phase 3, Pivotal, Open-label, Multicenter Study to Assess the Efficacy and Safety of Sutimlimab in Patients With Primary Cold Agglutinin Disease Who Have a Recent History of Blood Transfusion

Eligibility

Inclusion

  • Body weight of >= 39 kg at screening.
  • Confirmed diagnosis of primary CAD based on the following criteria: a) Chronic hemolysis; b) Polyspecific direct antiglobulin test (DAT) positive; c) Monospecific DAT strongly positive for C3d; d) Cold agglutinin titer >= 64 at 4 degree celsius; e) Immunoglobulin G (IgG) DAT less than or equal to (<=) 1+, and f) No overt malignant disease.
  • History of at least one documented blood transfusion within 6 months of enrollment.
  • Hemoglobin level <= 10.0 g/dL.
  • Bilirubin level above the normal reference range, including participants with Gilbert's Syndrome.

Exclusion

  • Cold agglutinin syndrome secondary to infection, rheumatologic disease, or active hematologic malignancy.
  • Clinically relevant infection of any kind within the month preceding enrollment (e.g., active hepatitis C, pneumonia).
  • Clinical diagnosis of systemic lupus erythematosus; or other autoimmune disorders with anti-nuclear antibodies at Screening. Anti-nuclear antibodies of long-standing duration without associated clinical symptoms adjudicated on a case-by-case basis during the Confirmatory Review of Patient Eligibility.
  • Positive hepatitis panel (including hepatitis B surface antigen and/or hepatitis C virus antibody) prior to or at Screening.
  • Positive human immunodeficiency virus (HIV) antibody at screening.
  • Treatment with rituximab monotherapy within 3 months or rituximab combination therapies (e.g., with bendamustine, fludarabine, ibrutinib, or cytotoxic drugs) within 6 months prior to enrollment.

Inclusion

  • You have had a certain type of treatment or surgical procedure.

Exclusion

  • You have certain types of non-cancer medical conditions.
  • You have had certain treatments, surgical procedures or drugs.
Message

Clinical trials have complex eligibility criteria.

Ask your doctor if this trial could be right for you.

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