CLINICAL TRIAL

REGN7257 for Anemia

Recruiting · 18+ · All Sexes · Paris, France

REGN7257 in Adult Patients With Severe Aplastic Anemia That Is Refractory to or Relapsed on Immunosuppressive Therapy

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About the trial for Anemia

Eligible Conditions
Anemia, Aplastic · Severe Aplastic Anemia (SAA) · Anemia

Treatment Groups

This trial involves 2 different treatments. REGN7257 is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are in Phase 1 & 2 and have already been tested with other people.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
REGN7257
DRUG
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

Eligibility

This trial is for patients born any sex aged 18 and older. You must have received 1 prior treatment for Anemia or one of the other 2 conditions listed above. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
, will be treated with nivolumab after disease progression on standard of care IST SAA that does not respond to or relapses while on standard of care IST, as defined in the protocol, will be treated with nivolumab after disease progression on standard of care IST. show original
Hematopoietic stem cell transplantation (HSCT) is not an option for the patient. show original
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: 12 months post-treatment, approximately 52 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: 12 months post-treatment, approximately 52 weeks.
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Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether REGN7257 will improve 4 primary outcomes and 18 secondary outcomes in patients with Anemia. Measurement will happen over the course of Up to 12 months.

Changes in the whole blood immune cell subsets (NK cells)
UP TO 12 MONTHS
Parts A and B
Changes in reticulocyte cell counts
UP TO 12 MONTHS
Parts A and B
Drug concentrations in serum over time
UP TO 12 MONTHS
Parts A and B
Time to best response
UP TO 12 MONTHS
Parts A and B
Changes in platelet cell counts
UP TO 12 MONTHS
Parts A and B
Changes in the whole blood immune cell subsets (B cells)
UP TO 12 MONTHS
Parts A and B
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What is anemia?

Anemia is a condition of insufficient hemoglobin in the blood or red blood cells or insufficient normal red blood cell count (erythrocyte count). Anemia can cause fatigue and shortness of breath. A complete blood count is used to assess the severity of anemia, and is often used as a guideline for treatment of anemia by blood transfusions.\n

Anonymous Patient Answer

How many people get anemia a year in the United States?

Anemia is the most common form of anemia in the U.S. and affects nearly 5% of the U.S. population, predominantly women, and disproportionately of different ethnic groups. The prevalence of anemia is highest in the elderly, women, and minorities. It can be improved with education, increased screening, and improved treatments.

Anonymous Patient Answer

Can anemia be cured?

Patients who achieve sufficient hemoglobin levels by adopting one of the recommended levels of daily iron or folic acid supplements may be able to achieve normal hemoglobin levels without regular medical therapy.

Anonymous Patient Answer

What causes anemia?

Iron deficiency is very common among Australian women. A high intake of iron may be protective against unexplained iron deficiency. A lower iron status does have a significant effect on aerobic exercise performance. Poor intake of iron from food contributes to low iron status in Australian women.

Anonymous Patient Answer

What are common treatments for anemia?

There are two major categories of treatment in primary and secondary care settings for anemia: (1) treating the cause of the anemia before it is diagnosed; and (2) treating it with medications. There are no treatments which are known to be effective when used as part of treatment for the anemia as a condition in itself. However, there are several drugs the majority of which are approved for other indications that would be effective for use in anemia associated with CKD.

Anonymous Patient Answer

What are the signs of anemia?

Signs can be detected and assessed qualitatively using medical knowledge to elicit an 'a-ha!' response from the person to reveal the severity of their symptoms.

Anonymous Patient Answer

What is the primary cause of anemia?

Anemia may have several causes. While some of the causes can be corrected such as blood loss, iron deficiency can't be treated with the iron supplement, iron deficiency can be treated with blood transfusion.

Anonymous Patient Answer

What is regn7257?

Regn7257 was safe and well tolerated in this pre-specified, prospective, exploratory study, despite the expected occurrence of anemia. The data from two short-term studies support a longer use of Regn7257 beyond the expected follow-up period.

Anonymous Patient Answer

What are the latest developments in regn7257 for therapeutic use?

The first published regn7257 data demonstrate its effectiveness in treatment of neutropenia following myeloablative chemotherapy. Clinical data from a phase II clinical trial of regn7257 in solid tumors were reported. In conjunction with the data on regn7257 published to date, the investigational new drug (IND) application for the use of regn7257 in the treatment of neutropenia following myeloablative neutropenic chemotherapy in oncology patients is currently pending.

Anonymous Patient Answer

Is regn7257 typically used in combination with any other treatments?

The overall clinical benefit associated with regn 7257 has been disappointing, which may potentially be attributed to its typically used in combination with chemotherapy or biologic therapy. Further study by combining regn 7257 with other new agents and the use of a matched control for the chemotherapy regimen is recommended.

Anonymous Patient Answer

What is the average age someone gets anemia?

[Among U.S. patients presenting for outpatient cancer care with unexplained anemia, approximately 18% were aged 50 years or older; however, almost one-third of all patients were under the age of 50.

Anonymous Patient Answer

Has regn7257 proven to be more effective than a placebo?

Regn 7257 shows promise as a potent and well-tolerated immunotherapeutic in patients with chronic lymphocytic leukemia. At an early stage of this Phase II trial and in light of the excellent safety profile achieved as well as the remarkable clinical benefit, this compound will be considered for larger clinical trials.

Anonymous Patient Answer
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