A phase I/II Study of REGN7257 (Anti-interleukin 2 receptor subunit gamma [IL2RG] monoclonal antibody) in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy | Aplastic Anemia & MDS International Foundation

ClinicalTrials.gov Identifier:

NCT04409080

Company

Regeneron Logo

Contact Info

Clinical Trials Administrator

clinicaltrials@regeneron.com

844-734-6643

Dates

Start: August 2020
End: July 2023

Official Title

A phase I/II Study of REGN7257 (Anti-interleukin 2 receptor subunit gamma [IL2RG] monoclonal antibody) in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy

Purpose

The primary objective of this study is to assess the safety and tolerability of REGN7257 in patients with severe aplastic anemia (SAA) that is refractory to or has relapsed while on standard of care immunosuppressive therapy (IST). An additional primary objective (for Part B only) is to evaluate the clinical efficacy of REGN7257 in IST-refractory/relapsed patients.

The secondary objectives of this study are to assess the following for REGN7257:

  • Clinical response over time
  • Maintenance of response
  • Impact on transfusion requirements
  • Effect on blood counts and cell populations
  • Pharmacokinetics (PK)
  • Immunogenicity

A phase I/II Study of REGN7257 (Anti-interleukin 2 receptor subunit gamma [IL2RG] monoclonal antibody) in patients with severe aplastic anemia that is refractory to or relapsed on immunosuppressive therapy

Clinical Trial: NCT04409080

Instructions

If you are interested in learning more about your possible participation in this clinical trial, please complete the form. Your information will be forwarded directly to the sponsoring company.

Status: 
Not yet recruiting
Phase: 
Phase 1
Phase 2
Gender: 
Female
Male
Age Group: 
18 years and older
Accepts Healthy Volunteers: 
No
Inclusion Criteria: 
  1. SAA that is refractory to or has relapsed while on standard of care IST, as defined in the protocol
  2. Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
  3. Adequate hepatic and renal function as defined in the protocol
Exclusion Criteria: 
  1. Diagnosis of Fanconi anemia as defined in the protocol
  2. Evidence of myelodysplastic syndrome as defined in the protocol
  3. Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of significant hemolysis or history of PNH-associated thrombosis
  4. Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing
  5. Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing
  6. Treatment with eltrombopag or investigational thrombopoietin receptor agonist, Granulocyte Colony-Stimulating Factor (G-CSF), or an androgen (eg, danazol), within 2 weeks prior to dosing
  7. HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit
  8. Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI

Note: Other protocol-defined inclusion/ exclusion criteria apply.

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