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:

• People who are willing to sign a consent form, follow the trial schedule, and agree to long-term follow-up for up to 15 years as required by health regulators.
• People aged 18 years or older.
• People with relapsed or refractory multiple myeloma who have had at least 3 previous rounds of treatment, including at least one type of proteasome inhibitor and at least one immunomodulator drug — or people with a related condition called relapsed/refractory primary plasma cell leukemia who have had at least 1 previous round of treatment, with at least one full cycle completed for each round.
• People whose disease has continued to grow or come back during or after their most recent treatment, based on established blood cancer guidelines.
• People whose disease can be measured through specific lab or test results (confirm with trial site for the exact measurements required).
• People whose doctors estimate they are expected to live more than 12 weeks.
• People with a general health/activity level score of 0 or 1 on a standard medical scale, meaning they are fully active or able to carry out light activities (confirm with trial site).
• People whose blood, organ, and other test results meet specific levels set by the trial (confirm with trial site for exact values).
• Women who could become pregnant must have a negative pregnancy test before starting and must use a highly effective form of contraception for 1 year after receiving the study treatment, and must not donate eggs for 1 year after treatment.
• Men who are sexually active with someone who could become pregnant must use a highly effective form of contraception for 1 year after receiving the study treatment, and must not donate sperm for 1 year after treatment.

Who may not be able to join:

• Women who are pregnant or breastfeeding.
• People with a significant medical condition, unusual lab result, or mental health condition that the treating doctor believes would make treatment unsafe or participation unsuitable.
• People who test positive for HIV, active hepatitis C, or active hepatitis B — though a past history of treated hepatitis B or C may be acceptable if testing shows no detectable virus.
• People with any uncontrolled active infection, including active tuberculosis, based on the treating doctor's judgement.
• People still experiencing side effects from previous treatments that have not improved to a mild level (Grade 1 or below on a standard scale), except for hair loss or other effects the treating doctor considers tolerable.
• People who have previously had a donor stem cell transplant, or who have had their own stem cells transplanted within 12 weeks before signing the consent form.
• People who have received treatment for their blood cancer within 14 days before signing the consent form.
• People who have received a cell-based therapy within 28 days before signing the consent form.
• People who have taken high-dose steroid tablets (equivalent to more than 15 mg per day of prednisone) in the 7 days before signing the consent form (skin-applied steroids are generally excepted).
• People who have received any live, inactivated, or mRNA vaccine within 4 weeks before signing the consent form.
• People who are allergic or intolerant to the preparatory chemotherapy used before cell therapy, to the drug tocilizumab, or to any ingredients in the study cell product (including a preservative called DMSO) — or people with a history of severe allergic reactions such as anaphylactic shock.
• People diagnosed with certain other blood or protein disorders, including Waldenström macroglobulinemia, POEMS syndrome, or primary light chain amyloidosis.
• People who have had certain serious heart conditions within the 6 months before screening (confirm with trial site for the specific conditions listed).
• People who need extra oxygen to keep their blood oxygen levels above 92%, or people with a known lung condition where breathing tests show significantly reduced lung function.
• People with active autoimmune diseases — such as psoriasis or rheumatoid arthritis — that require ongoing immune-suppressing treatment.
• People who have a second cancer that has needed treatment in the past 2 years or is not fully cleared, with some exceptions for certain skin cancers, non-spreading prostate cancer, early-stage breast or cervical changes, or early bladder cancer that have been successfully treated.
• People with active or suspected cancer affecting the brain or spinal cord.
• People who have had major surgery within 2 weeks before signing the consent form, or who have major surgery planned during the study or within 4 weeks of receiving the study treatment (minor procedures such as cataract surgery are generally excepted).

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