Phase 1 Leukaemia 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 18 years of age or older at the time of signing the consent form
• People who have been diagnosed with a type of blood cancer called AML, where at least 70% of the cancer cells carry a protein called CD19 (measured by a lab test called flow cytometry)
• People whose AML has not responded to treatment or has come back, including: those whose AML did not go into remission after two rounds of initial chemotherapy; those whose AML did not respond to further treatment after relapsing; or those whose AML came back after a bone marrow/stem cell transplant
• People for whom no other suitable targeted treatment option is available that has not already been tried
• People who are generally able to carry out daily activities with little or no difficulty (confirm with trial site regarding the specific fitness score required)
• People with an estimated life expectancy of more than 2 months
• People whose brain scan (MRI) shows no signs of cancer in the brain or central nervous system
• People whose side effects from previous treatments have mostly resolved to a mild level or lower (with some exceptions such as hair loss)
• People whose blood platelet count meets a minimum level (confirm with trial site for exact number)
• People whose immune cell (lymphocyte) count meets a minimum level (confirm with trial site for exact number)
• People whose kidneys are functioning well enough, as measured by a standard calculation
• People whose liver enzyme levels (ALT/AST) are within an acceptable range
• People whose total bilirubin level is within an acceptable range (a different standard may apply for people with a condition called Gilbert's syndrome)
• People whose heart is pumping blood effectively enough, as measured by an ejection fraction of at least 45%
• People with no significant abnormalities on a heart tracing (ECG) test
• People with no significant fluid around the lungs
• People whose blood oxygen levels are above 92% when breathing normal room air
• Women who could become pregnant must have a negative blood pregnancy test before starting, must use a reliable form of contraception for at least one year after the treatment infusion, and must agree not to breastfeed during the study and for one year after the infusion
• Men must agree to use a condom during sexual contact with a woman who is pregnant or could become pregnant for at least one year after the treatment infusion, even if they have had a vasectomy

Who may not be able to join:

• People who are unable to sign the consent form themselves
• People whose AML cancer cells do not carry the CD19 protein
• People who have had another type of cancer in the past, unless they have been cancer-free and off cancer treatment for at least 3 years (some minor skin cancers or very early-stage cancers may be exceptions)
• People who have previously received a treatment that targets CD19
• People who have previously received a CAR-T cell therapy or any other type of genetically modified T cell therapy
• People who have an active infection (fungal, bacterial, viral, or other) that is not under control or that requires intravenous antibiotics or antifungal treatment
• People who have a history of HIV or HTLV-1 infection
• People with an active hepatitis C infection, or an active hepatitis B infection (people with a past hepatitis B or C infection may still be considered if standard tests confirm the infection has fully cleared)
• People who have cancer cells detected in the fluid around the brain or spine, or who have a known history of this
• People who have a non-cancer-related condition affecting the brain or nervous system, such as a seizure disorder, stroke history, dementia, or certain autoimmune conditions involving the nervous system
• People who are under legal guardianship or curatorship
• Women who are pregnant, breastfeeding, or planning to become pregnant
• People who have a known allergy or sensitivity to the treatment substance or any of its ingredients
• People for whom the preparatory chemotherapy given before the infusion is not medically suitable
• People who do not have medical insurance coverage

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