Early Phase 1 Lymphoma 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 or older
• People who have signed a consent form agreeing to take part (or have a legal representative who has done so)
• People who agree to allow stored tumour tissue from a previous biopsy to be used for the study (exceptions may be possible with approval from the lead researcher)
• People who have been diagnosed with high-risk acute lymphoblastic leukaemia (ALL) — a type of blood cancer — that meets at least one of these conditions: small amounts of cancer remaining after treatment (called MRD positive) at the time of a stem cell transplant; 5% or more cancer cells (blasts) present at the time of transplant; being in a second or later remission regardless of remaining cancer levels; or needing more than one treatment course to reach first remission
• People whose leukaemia has been confirmed by a laboratory report to carry a protein called CD19 (either at the time of active disease or before the most recent treatment during remission)
• People who are planned to receive a stem cell transplant from a matched donor, using stem cells from blood or bone marrow
• People who have previously received other types of CAR T-cell therapy
• People who have no known reasons why they cannot receive a stem cell transplant, a blood cell collection procedure (leukapheresis), steroids, the drug tocilizumab, or certain vaccines
• People whose liver function blood test results (bilirubin, AST, and ALT) fall within the acceptable ranges required by the trial (tested within 45 days before the stem cell infusion)
• People whose kidney function is within the acceptable range and who are not on dialysis (tested within 45 days before the stem cell infusion)
• People whose heart electrical activity (ECG reading) and heart pumping strength (ejection fraction of at least 45%) meet the trial's required levels (tested within 45 days before the stem cell infusion)
• People whose blood oxygen level is above 92% without needing extra oxygen
• People who test negative for HIV, hepatitis B, hepatitis C, syphilis, COVID-19, a virus called HHV-6, and tuberculosis (TB), as confirmed by required tests within the required timeframes
• People who test negative for pregnancy (for those who could become pregnant), tested within 45 days before the stem cell infusion
• People who agree to use effective contraception or abstain from sexual activity that could result in pregnancy throughout the study and for at least 6 months after the last treatment
• People whose general health and ability to carry out daily activities meets the required level on a standard medical scale (Karnofsky score of 70 or higher)

Regarding the stem cell donor, the trial also requires:

• The donor must be the same person who originally donated stem cells for the participant's transplant
• The donor must test positive for a specific type of immunity to a virus called CMV, confirmed through specific laboratory testing
• The donor must test negative for hepatitis B, hepatitis C, HIV, and other specified infections
• The donor must also meet the health activity level requirement (Karnofsky score of 70 or higher)
• The donor must be willing to sign a donor consent form and undergo a procedure to collect immune cells (T-cell leukapheresis)
• The donor must have completed all required health assessments and infection screenings according to institutional and regulatory (FDA) guidelines

Who may not be able to join:

• People currently taking systemic (whole-body) steroid medications — though low-dose replacement steroids and standard inhaled or topical steroids are generally not disqualifying
• People with an active autoimmune disease that requires ongoing immune-suppressing treatment
• People who have medical reasons preventing them from safely receiving standard transplant preparation treatments
• People with a significant irregular heartbeat that has not been stable with treatment in the two weeks before screening
• People with a history of, or currently active, neurological or inflammatory disease affecting the brain or nervous system — including uncontrolled seizures, measurable masses in the brain, or other active brain-related conditions (though people whose CNS disease has been fully treated to remission may still be eligible — confirm with trial site)
• People with uncontrolled serious illness, including certain heart conditions, poorly controlled lung disease, or mental health or social situations that could make it difficult to follow the study's requirements
• People who have had a significant allergic reaction to a medication or substance similar to the ones used in this trial
• People who have had a stroke or bleeding in the brain within the 3 months before screening
• People with known bleeding disorders, such as von Willebrand's disease or haemophilia
• People with uncontrolled seizures
• People with active viral hepatitis
• People with a history of another cancer, unless it was treated with the intent to cure, has shown no signs of returning for 2 or more years, or falls into specific low-risk skin or bladder cancer categories
• People with an active infection that is not responding to antibiotic treatment
• People who are pregnant or breastfeeding
• People whom the trial investigator believes should not participate for safety reasons related to the study procedures
• People whom the investigator believes may not be able to follow all study requirements

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