Status:
TERMINATED
REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
Lead Sponsor:
Regeneron Pharmaceuticals
Conditions:
Severe Aplastic Anemia (SAA)
Eligibility:
All Genders
18+ years
Phase:
PHASE1
Brief Summary
This study is researching an experimental drug called REGN7257 (called "study drug"). The study is focused on patients who have severe aplastic anemia (SAA), a disease of the bone marrow resulting in ...
Detailed Description
The trial was intended to be a Phase 1/2 trial, but no participants were enrolled in Phase 2
Eligibility Criteria
Inclusion
- Key
- Part A: SAA that is IST-refractory or IST-relapsed, as defined in the protocol
- Part B: SAA that is IST-relapsed, as defined in the protocol
- Hematopoietic stem cell transplantation (HSCT) is not available or suitable as a treatment option or has been refused by the patient
- Adequate hepatic and renal function as defined in the protocol
- Key
Exclusion
- Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol
- Evidence of myelodysplastic syndrome as defined in the protocol
- Paroxysmal nocturnal hemoglobinuria (PNH) with evidence of clinically significant hemolysis (eg, treatment indicated) or history of PNH-associated thrombosis
- Treatment with a T cell-depleting agent (eg, ATG or alemtuzumab) within 6 months prior to dosing
- Treatment with a calcineurin inhibitor (eg, cyclosporine) within 4 weeks prior to dosing for patients enrolled in Part A
- 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
- HIV, hepatitis B or hepatitis C positive by serological testing at the screening visit as defined in the protocol
- Active tuberculosis, latent tuberculosis infection (LTBI) or history incompletely-treated tuberculosis or LTBI
- Active infection as defined in the protocol
- Note: Other protocol-defined inclusion/ exclusion criteria apply
Key Trial Info
Start Date :
January 13 2021
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
October 17 2024
Estimated Enrollment :
17 Patients enrolled
Trial Details
Trial ID
NCT04409080
Start Date
January 13 2021
End Date
October 17 2024
Last Update
October 24 2025
Active Locations (10)
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1
Cleveland Clinic Foundation
Cleveland, Ohio, United States, 44195
2
The University of Texas MD Anderson Cancer Center
Houston, Texas, United States, 77030
3
Hopital Saint-Louis - APHP
Paris, Île-de-France Region, France, 75010
4
Gachon University Gil Hospital
Incheon, Gyeonggi-do, South Korea, 21565