Phase 1 Sickle Cell Disease Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

• You are 18 years of age or older and have been diagnosed with severe sickle cell disease (SCD), meaning you are currently on regular blood transfusion therapy due to SCD complications, or you qualify for (or are already enrolled in) a bone marrow transplant program
• Your sickle cell disease diagnosis and specific type (genotype) has been confirmed and documented in your medical records
• You have a suitable way for medical staff to access your veins for a blood collection procedure (called apheresis), either through an existing central line, good enough veins, or you are willing to have a central line placed if needed
• You are in reasonably good general health, as measured by a standard health performance score (confirm with trial site)
• Your blood counts (white blood cells, neutrophils, platelets) and hemoglobin levels meet minimum required levels (confirm with trial site for exact numbers)
• Your kidneys are working well enough, based on blood tests measuring kidney function
• Your liver is working well enough, based on blood tests measuring liver enzyme and bilirubin levels
• Your heart is pumping effectively (ejection fraction above 40%) and you do not have high blood pressure in your lungs, based on a heart scan done within the last 6 months
• Your blood tests show no signs of syphilis, hepatitis B or C, HIV, or HTLV-1/II infections
• There is a workable plan to reduce your sickle hemoglobin (HbS) levels through a blood exchange transfusion before the stem cell collection process begins
• If you are a woman who could become pregnant, you have a negative pregnancy test before joining
• If you could become pregnant or father a child, you agree to use highly effective contraception during the study and for at least one month after your last dose of the study drug (motixafortide) — specific acceptable methods include hormonal contraception, an intrauterine device (IUD or IUS), surgical procedures, a vasectomised partner, or complete abstinence

Who may not be able to join:

• You have an enlarged and painful spleen, or your spleen is larger than the normal expected size
• You require very rare or specially matched blood donations for transfusions, or you are unable to receive routine blood transfusions for any reason
• You have a known allergy to, or a medical reason not to take, the study drug (motixafortide) or other medications typically used during the blood collection procedure
• You have previously had a bone marrow/stem cell transplant of any kind, including gene therapy
• You currently have an active infection of any kind (viral, bacterial, fungal, or parasitic)
• You have a history of cancer, with the exception of certain non-invasive skin or cervical conditions (confirm with trial site)
• You have received any experimental treatment within 4 weeks before signing the consent form to join this study
• You have diabetes that is not well controlled, as determined by the study doctor
• You are currently taking another experimental treatment that cannot be paused for 30 days
• You are unwilling to use effective contraception for one month after the last dose of the study drug
• You are currently pregnant
• You are unwilling or unable to sign a written consent form agreeing to participate in the study
• You are unwilling or unable to stop taking hydroxyurea (a common sickle cell medication) for 30 days before receiving the first dose of the study drug

Important: Always verify eligibility with the trial site directly before applying.