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 (any gender)
• You have already received at least 3 different treatment regimens for multiple myeloma, including at least one proteasome inhibitor and one immunomodulatory drug, and your disease has come back, gotten worse, or stopped responding to treatment
• Testing of your cancer cells has shown a protein called BCMA on their surface, and you have never previously received a specific type of treatment called BCMA CAR-T therapy
• Your disease shows measurable signs of getting worse, such as rising levels of certain proteins in your blood or urine, or an increase in cancer cells in your bone marrow (confirm with trial site for which specific measure applies to you)
• Your general health and ability to carry out daily activities is rated as good to moderate on a standard medical scale (ECOG score 0–2)
• Doctors expect you to live for at least 12 weeks
• Your blood counts, liver, kidneys, clotting system, blood oxygen levels, and heart function all meet certain minimum standards shown in blood and other tests (confirm specific values with trial site)
• You and your partner agree to use effective contraception from signing the consent form until one year after receiving the CAR-T cell treatment
• You are willing and able to sign a written consent form before any trial procedures begin

Who may not be able to join:

• You have active hepatitis B, hepatitis C, HIV, or syphilis infections based on blood tests
• You have received certain myeloma treatments — such as monoclonal antibodies or CNS radiation within the past 8 weeks, or chemotherapy/immunotherapy/proteasome inhibitor therapy within the past 14 days before a key cell collection procedure
• You have received certain immune-boosting injections (GM-CSF or long-acting G-CSF) within the past 14 days before cell collection
• You have used higher-dose steroid medicines (such as prednisone above 20 mg/day) within the past 7 days (low-dose, topical, or inhaled steroids may be allowed)
• You have received treatments containing bendamustine or fludarabine within the past 12 weeks
• You have a form of myeloma called plasma cell leukemia, or there is concern the myeloma has spread to your brain or spinal cord
• You have previously had a bone marrow or stem cell transplant from another person (allogeneic transplant)
• You have had another type of cancer in the past 5 years, with some exceptions such as certain treated skin cancers or early-stage cancers that were fully removed (confirm with trial site)
• You have previously had a transplant of a solid organ (such as a kidney, liver, or heart)
• You have had major surgery within the past 2 weeks before cell collection, or major surgery is planned within 2 weeks after starting treatment
• You have received a live vaccine within the past 4 weeks before starting the pre-treatment medication
• You have a serious ongoing health condition, such as an autoimmune disease requiring long-term immune-suppressing treatment, an uncontrolled active infection, poorly controlled diabetes, serious heart problems (including recent heart attack or significant heart failure), high blood pressure that cannot be controlled with medication, or a significant psychiatric or nervous system disorder
• You are currently taking part in another interventional clinical trial and received that trial's medication within the past month
• You are pregnant, breastfeeding, or plan to become pregnant during the trial or within 6 months after it ends
• You have a history of severe allergic reactions, or are known to be allergic to any of the drugs or ingredients used in this trial
• The trial doctors have identified another reason they consider you unsuitable for the trial

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