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 take part voluntarily, have signed an agreement to participate, and are able to follow the study requirements
• People aged 18 to 75 years old (based on the date of signing the participation agreement), who have a general health/activity level rated 0 to 2 on a standard scale, and who are expected to live for more than 12 weeks
• People who have been diagnosed with multiple myeloma, have records confirming this diagnosis, have a measurable sign of the disease, have already received at least one round of treatment, and whose disease has not responded to at least one of each of three specific types of treatment (a proteasome inhibitor, an immunomodulator, and a CD38 monoclonal antibody), and whose disease has gotten worse within 12 months of their last treatment
• People whose recent blood and body fluid test results meet the specific standards set out in the study plan
• Women who are able to become pregnant must agree to use effective contraception during the study and for 6 months after it ends, and must have a negative pregnancy test within 7 days before joining; men must agree to use effective contraception for 6 months after the study ends

Who may not be able to join:

• People diagnosed with certain related blood or plasma cell conditions, including amyloidosis, active plasma cell leukaemia, Waldenström's macroglobulinaemia, or POEMS syndrome
• People who have had a donor stem cell transplant within the past year, or their own stem cells transplanted back within the past 12 weeks
• People who are known or strongly suspected to have the disease spreading to the brain or the fluid surrounding the brain and spinal cord
• People who have previously received a specific type of treatment known as CD3×BCMA dual antibody therapy
• People who have recently received certain treatments within defined timeframes before joining — including high-dose steroid treatment, targeted therapies, chemotherapy, antibody treatments, proteasome inhibitors, radiation, or immunomodulating therapy — each within specific windows of weeks before the first dose (confirm with trial site for exact timeframes)
• People who have received a traditional Chinese medicine product within 2 weeks before the first dose, where that product is officially approved to treat cancer
• People who have received a live vaccine within 4 weeks before the first dose, or who plan to receive one during the study
• People with a history of serious allergic reactions of unknown cause, or who are known to be allergic to monoclonal antibody drugs, human immunoglobulin products, or the study drug TQB2934 or its ingredients
• People who have had another type of cancer within the past 3 years, or who currently have another cancer
• People who still have side effects from previous treatments rated above a mild level (except for hair loss, tiredness, and nerve-related symptoms in the hands or feet)
• People who have had major surgery, a serious injury, or an expected study-related procedure within 4 weeks before the first dose, or who have wounds or fractures that have not healed
• People who have had a blood clot in an artery or vein within the 6 months before the first dose
• People with a history of misusing substances affecting the mind and who are unable to stop, or who have a mental health condition, or who have epilepsy requiring treatment
• People whose blood pressure is not well controlled
• People whose diabetes is not well controlled
• People who have a serious bacterial, viral, or widespread fungal infection that is active or uncontrolled within 4 weeks before the first dose
• People with active hepatitis or advanced liver disease (decompensated cirrhosis)
• People with active tuberculosis, certain lung conditions such as idiopathic pulmonary fibrosis, organising pneumonia, drug-induced lung inflammation, radiation-related lung inflammation requiring treatment, or active pneumonia with symptoms
• People who have had or currently have asthma within the 2 years before the first dose, or who have chronic obstructive pulmonary disease (COPD) with significantly reduced lung function (confirm with trial site)
• People with serious heart or cardiovascular disease
• People with a history of immune system deficiency
• People who, in the treating doctor's judgement, have other conditions that could put them at serious risk or prevent them from completing the study

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