Early Phase 1 Myeloma 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 between 18 and 75 years old
• You are able to understand and willing to sign a consent form before any study procedures begin
• Doctors expect you to live for at least 12 weeks
• You are reasonably active and able to care for yourself (your doctor can confirm this using a standard activity scale)
• A bone marrow test has shown that your cancer cells carry a specific protein called BCMA on their surface
• You have been diagnosed with multiple myeloma that can be measured through at least one of the following: a blood protein test, a urine test, a blood light chain test, or a bone marrow examination (confirm with trial site)
• You have already tried at least three different types of myeloma treatments (including anti-CD38 antibody therapy, protease inhibitor therapy, and immunotherapy) and your myeloma has come back, stopped responding, or you could not tolerate your most recent treatment
• Your lungs are working well enough and your blood oxygen level is above 92% without needing extra oxygen
• Your liver is functioning within acceptable levels, based on blood tests
• Your kidneys are functioning well enough, based on blood tests
• Your blood cell counts (white cells, red cells, and platelets) are at or above minimum required levels
• If you are a woman who could become pregnant, your pregnancy test must be negative, and both you and your partner must agree to use effective contraception from signing the consent form until 2 years after receiving the study drug

Who may not be able to join:

• You have a form of multiple myeloma that causes no symptoms (called "smouldering" myeloma)
• Your myeloma exists only outside the bone marrow with no involvement inside the bone marrow
• You have a condition called plasma cell leukaemia
• You have a condition called amyloidosis alongside your myeloma
• Your cancer has spread to the brain or the fluid around the brain or spinal cord
• You are currently pregnant or breastfeeding
• You have certain infections including active hepatitis B, hepatitis C, HIV, syphilis, or cytomegalovirus (CMV), unless specific test results fall below certain thresholds (confirm with trial site)
• You have certain significant heart problems, including a specific abnormal heart rhythm reading on an ECG, moderate or severe heart failure, reduced heart pumping function, poorly controlled high blood pressure, or certain serious irregular heartbeats
• You have had a heart attack or severe chest pain (unstable angina) in the 6 months before joining the study
• You have previously received treatment with anti-CD45 or anti-CD3 therapies
• You are known to be allergic to any of the drugs used in this study, including cyclophosphamide or fludarabine
• You have received another experimental drug or cancer treatment within 4 weeks (or within a certain number of drug half-lives) before a key procedure called a "single collection"
• You have had another type of cancer in the past 5 years, with exceptions for fully treated early-stage cervical cancer or certain minor skin cancers
• You have had an uncontrolled active infection requiring intravenous antibiotics, antiviral, or antifungal treatment within the 4 weeks before the single collection procedure
• You have had active tuberculosis within the past year (confirm with trial site if your TB history is older than one year)
• You have a history of, or currently have, scarring or inflammation of the lungs (interstitial lung disease or interstitial pneumonia)
• You have had your own stem cells transplanted back into you (autologous stem cell transplant) within 8 weeks of signing the consent form, or you are planning to have this procedure during the study
• You have previously received a stem cell transplant from another person (allogeneic transplant)
• Your doctor believes another medical condition or circumstance makes it unsuitable or unsafe for you to take part

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