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:

• People aged 18 to 75 years (including those ages exactly 18 or 75), of any gender
• People who have been diagnosed with multiple myeloma according to specific Chinese clinical guidelines, with confirmed abnormal plasma cells in the bone marrow or a type of tumour called a plasmacytoma, plus at least one sign of disease impact such as high calcium levels, kidney problems, anaemia, or bone damage detected on imaging
• People whose multiple myeloma has come back or stopped responding to treatment, having already gone through at least three different treatment courses (including at least one proteasome inhibitor, one immunomodulatory drug, or one anti-CD38 antibody), and whose disease worsened during or shortly after their most recent treatment
• People who have at least one measurable sign of the disease, such as detectable proteins in the blood or urine, abnormal light chain levels in the blood, a confirmed plasma cell tumour on biopsy, or a high proportion of plasma cells in the bone marrow
• People who test negative for a specific type of immune marker called Donor Specific Antibody (DSA)
• People whose kidneys and liver are working well enough, based on recent blood test results during the screening period
• Women who could become pregnant must have a negative pregnancy test within 7 days before joining, and must use effective contraception from the screening period until 12 months after receiving the study treatment; this requirement also applies to male partners with the ability to father children — women who are post-menopausal for at least one year or have documented infertility are not subject to this requirement
• People who are willing and able to give written consent before any study procedures begin

Who may not be able to join:

• Women who are currently breastfeeding
• People who are unwilling to attend follow-up appointments for 15 years after the study
• People who are unlikely to follow the study procedures reliably
• People who are under legal guardianship or conservatorship
• People who previously received a type of immune cell therapy called CAR-T and experienced a severe (Grade 4 or higher) immune reaction or serious nervous system side effects from it
• People who have recently received other multiple myeloma treatments and have not yet waited the required time (five half-lives of each drug) before joining this trial
• People whose disease continued to get worse after receiving a treatment designed to reduce the amount of myeloma before the main therapy
• People with active problems affecting the brain or nervous system, or lasting serious nervous system damage caused by previous myeloma treatment
• People who received radiation-based therapy within the 8 weeks before joining
• People who received a stem cell transplant within 3 months before screening, a donor lymphocyte infusion within 6 weeks before screening, an autologous (own cells) stem cell transplant within 100 days before joining, or any solid organ transplant at any time
• People with active graft-versus-host disease (a condition where donor cells attack the body) requiring ongoing systemic treatment within 4 weeks before receiving the study treatment
• People with autoimmune diseases who cannot stop taking immune-suppressing medications
• People who have recently received high doses of steroid medications (such as dexamethasone) within the 4 weeks before a preparatory treatment step
• People with a known allergy or sensitivity to the study treatment (UCAR-T) or any of its ingredients
• People with uncontrolled heart problems in the 6 months before joining, including certain types of irregular heartbeat, slow heart rate, heart attack, unstable chest pain, heart failure, stroke, blood clots in the lungs or legs, poorly controlled high blood pressure, or a weak pumping function of the heart detected on a heart scan
• People with uncontrolled lung problems in the 6 months before joining, including blood clots in the lungs, chronic obstructive pulmonary disease, certain types of lung scarring or inflammation, or active signs of pneumonia on a chest scan
• People who had a severe high blood pressure crisis or related brain condition within 3 months before screening
• People with an active infection (bacterial, fungal, parasitic, or viral) that is not well controlled despite treatment, or who had a positive blood culture within 7 days before joining
• People who had major surgery within 3 months before screening
• People who received a live vaccine within 4 weeks before screening
• People whose test results, medical history, or other findings during screening raise concerns about their safety, as assessed by the trial doctor
• People who have planned medical or surgical treatments that could interfere with the trial
• People who have had another cancer within the 2 years before screening (excluding certain early-stage skin or cervical cancers)
• People whose mental health condition prevents them from understanding or participating in the study, or who are unwilling to cooperate
• People who test positive for certain infections at the time of joining, including active hepatitis B, active hepatitis C, HIV, HTLV, syphilis, or cytomegalovirus (CMV)
• People who have known contraindications to any medications that may be used in this trial, including the preparatory chemotherapy drugs fludarabine and cyclophosphamide, or medications used to manage side effects such as tocilizumab

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