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 between 18 and 85 years.
• People who have a blood cancer that has been confirmed by laboratory testing and falls under a recognised classification system, and for which an FDA-approved CAR T-cell therapy product is commercially available.
• People whose blood cancer has come back after treatment, or whose cancer did not respond well enough to their most recent treatment.
• People for whom at least 2 weeks (or 5 half-lives of the drug, whichever is shorter) have passed since their last cancer treatment before the planned cell collection procedure.
• People whose side effects from previous treatments have mostly settled down to a mild level or better (hair loss is an exception and does not need to have resolved).
• People with an active infection must have that infection resolved before starting CAR T-cell treatment.
• People with a general health and activity level rated as largely independent (ECOG performance status of 0–2, confirm with trial site).
• People with adequate blood counts, liver function, and heart function (confirm with trial site for specific thresholds).
• Women who could potentially become pregnant will need to have a pregnancy blood test at the screening stage.
• People who are willing to provide research samples as outlined in the study plan.
• People who are able to give written informed consent and are willing and able to follow the requirements of the study.

Who may not be able to join:

• People who have had, or are planning to have, a stem cell transplant using their own cells within 8 weeks of the planned CAR T-cell infusion.
• People who have had a stem cell transplant using a donor's cells within 8 weeks of the planned CAR T-cell infusion.
• People who have an active or suspected infection (fungal, bacterial, viral, or other) that is not under control, or that requires antibiotics or antifungals given through a drip (IV), at the time of screening.
• People who have had a heart attack, heart procedure (such as stenting or angioplasty), unstable chest pain, or another significant heart condition within the past 6 months.
• People with a history of seizures, stroke or brain bleeding, dementia, or an autoimmune disease that affects the brain or nervous system.
• People currently taking corticosteroids (such as prednisone) at a dose of 5 mg per day or more, or equivalent doses of other immune-suppressing medications — a specific washout period is required before certain study procedures (confirm exact timing with trial site).
• People with any other medical condition that is likely to interfere with the safety or assessment of the study treatment.
• People who have received a live vaccine within 6 weeks before the planned start of the preparatory chemotherapy.
• People who have had a severe allergic reaction to any of the medications used in this study.
• People who are currently pregnant or breastfeeding, due to the potential risks of the preparatory chemotherapy to a baby or infant.
• People of any sex who are not willing to use birth control from the time of consent through to 6 months after completing the preparatory chemotherapy (this does not apply to women who have had surgical sterilisation or have been through menopause for at least 1 year).
• People whom the study investigator believes are unlikely to complete all required study visits, procedures, or follow-up appointments.
• People whose bone marrow biopsy at screening shows signs of a specific type of abnormal cell growth (myeloid clonal haematopoiesis), due to the associated risk of developing certain blood cancers with part of this study's treatment.

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