Phase 1 Leukaemia Trial, Recruiting

Written by an AI model from the 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 or older.
• People who are able to understand and sign a written consent form.
• People whose cancer has not significantly limited their ability to carry out daily activities (based on a standard performance scale scored 0, 1, or 2).
• People with CLL or SLL (in the USA) whose cancer has come back or stopped responding to at least two prior standard treatments.
• People with CLL or SLL (in Spain) whose cancer has come back or stopped responding to at least two prior standard treatments, and for whom no other treatments known to help are available.
• People who have stopped their previous CLL or SLL treatment long enough ago to meet specific timing requirements based on that treatment type (confirm with trial site for exact timing); prior CAR-T cell therapy is allowed.
• People with a life expectancy of more than 16 weeks.
• People who have been diagnosed with CLL or SLL according to recognised medical guidelines at some point during their illness.
• People whose CLL or SLL currently meets standard medical criteria for active disease.
• People with a platelet count of at least 50,000 per microlitre, unless a lower count is caused by CLL affecting the bone marrow.
• People with adequate liver function based on specific blood test results (confirm with trial site).
• People with adequate kidney function based on a standard kidney function calculation (confirm with trial site).
• Women who could become pregnant and men whose partners could become pregnant must agree to use effective contraception during the trial and for 4 months after the last treatment; women who could become pregnant must have a negative pregnancy blood test within 7 days before the first trial dose.

Who may not be able to join:

• People who have had a stem cell transplant from a donor within the past 6 months.
• People who have received a monoclonal antibody cancer treatment within the past 4 weeks.
• People who still have side effects from previous cancer treatment that have not improved to a mild level.
• People who have recently taken certain targeted oral cancer medications (such as BTK inhibitors, BCL-2 inhibitors, or PI3K inhibitors) within a specific timeframe based on each medication (confirm with trial site).
• People who currently have an active infection (viral, bacterial, or fungal) that requires treatment.
• People who are known to be HIV-positive.
• People with active lymphoma affecting the brain or central nervous system.
• Women who are pregnant or breastfeeding.
• People who have had another cancer diagnosis within the past 2 years, except in specific circumstances such as cancers treated with curative intent, skin cancers, cancers in situ, or prostate cancer being monitored without treatment.
• People with certain serious or uncontrolled health conditions, including severe heart failure, a heart attack within the past 6 months, poor heart pumping function, life-threatening heart rhythm problems, unstable chest pain, brain metastases, or a psychiatric condition that would make it difficult to follow the trial requirements.
• People with a known allergy or sensitivity to any ingredient in the trial medication.
• People with a history of a specific type of immune reaction to antibody-based treatments (human anti-globulin antibodies).
• People with an active autoimmune disease, nerve problems thought to be caused by the immune system, or other autoimmune conditions affecting the brain or nervous system.

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