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REGN7257 in Adult Patients with Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy
EU CTIS ID: 2023-508601-24-00
What this study is testing
The primary objective of this study is to assess the safety and tolerability of REGN7257 in patients with IST-refractory or IST-relapsed SAA. An additional primary objective (for Part B only) is to evaluate the clinical efficacy of REGN7257 in patients with IST-relapsed SAA as proof of concept
- Phase I and Phase II (Integrated)- First administration to humans
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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
- Other protocol-defined inclusion criteria apply
You likely can't join if
- Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol
- Other protocol-defined exclusion criteria apply
- 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
See the full eligibility criteria
- 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
- Other protocol-defined inclusion criteria apply
- Diagnosis of Fanconi anemia or other congenital bone marrow failure syndrome as defined in the protocol
- Other protocol-defined exclusion criteria apply
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- United Kingdom
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; United Kingdom; United States. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.