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 old, of any gender.
• People who have already been treated with at least 3 different previous treatment plans for their condition, including treatments from two specific drug groups (proteasome inhibitors and immunomodulatory agents).
• People whose multiple myeloma or plasma cell leukemia has come back, gotten worse, or stopped responding to treatment.
• People whose cancer cells show a specific protein marker called GPRC5D, confirmed by a laboratory test on a tissue sample (such as a bone marrow biopsy).
• People whose disease can be measured in at least one specific way, such as a bone marrow test showing enough abnormal plasma cells, certain protein levels in the blood or urine meeting defined thresholds, or a tumour outside the bone marrow measuring at least 2cm (confirm with trial site for exact thresholds).
• People with a general health/activity level rated at 0, 1, or 2 on a standard medical scale (meaning able to carry out at least some daily activities).
• People with an estimated life expectancy of at least 12 weeks.
• People whose blood counts, liver, kidney, heart, and clotting functions all meet the specific levels required by the trial (confirm with trial site for exact values).
• People whose blood oxygen level is above 91%.
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%.
• People who agree to use effective contraception from the time of consent until one year after the CAR T cell treatment is given.
• People who are able to sign an ethics board-approved consent form before any screening begins.

Who may not be able to join:

• People who have a condition called graft-versus-host disease (GVHD), or who need long-term medicines to suppress their immune system.
• People who have received certain recent cancer treatments too close to the start of the cell collection procedure (the waiting period required varies by treatment type — confirm with trial site).
• People who have taken higher-dose steroid medicines (such as prednisone above 20mg daily or equivalent) within 7 days before screening, unless it was for a specific limited purpose such as inhaled or skin-applied steroids.
• People with high blood pressure that cannot be controlled with medication.
• People with serious heart conditions, including unstable chest pain, a heart attack within the past 6 months, significant heart failure, or severe irregular heartbeat.
• People with unstable serious conditions affecting organs such as the liver, kidneys, or metabolism that require ongoing medical treatment.
• People who have had another type of cancer in the past 5 years, with some exceptions for certain fully treated cancers (confirm with trial site).
• People who have had an organ transplant at any point.
• People who have had major surgery within 2 weeks before the cell collection procedure, or who expect to have surgery during or within 2 weeks after the study treatment (minor procedures under local anaesthetic may be exceptions — confirm with trial site).
• People who participated in another interventional clinical trial within 1 month before signing the consent form.
• People who have an active uncontrolled infection requiring systemic treatment within 7 days before the cell collection procedure, with limited exceptions for minor infections (confirm with trial site).
• People who test positive for hepatitis B, hepatitis C, HIV, cytomegalovirus (CMV), or syphilis under the specific testing conditions described in the trial protocol.
• People who are pregnant or breastfeeding.
• People with a mental health condition, impaired consciousness, or a disease affecting the central nervous system (brain and spinal cord).
• People who the trial investigators consider unsuitable for other reasons.

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