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:

For people with B-cell Acute Lymphoblastic Leukaemia (B-ALL):

• People aged 3 to 69 years old
• People who have a laboratory-confirmed diagnosis of a type of blood cancer called CD19+ B-ALL
• People whose cancer has come back or has not responded to treatment, such as: standard chemotherapy did not achieve remission; remission lasted 12 months or less after the first round of treatment; one or more follow-up treatments did not work; or the cancer has come back two or more times
• People whose bone marrow testing shows more than a minimum threshold of abnormal cancer cells (confirm with trial site for exact figures)
• People whose cancer tests negative for the Philadelphia chromosome, or who test positive but whose treating doctor determines they cannot tolerate or have not responded to at least two targeted therapy medicines called TKIs

For people with certain types of Non-Hodgkin Lymphoma (NHL):

• People aged 18 to 69 years old
• People with a laboratory-confirmed diagnosis of certain B-cell lymphomas, including DLBCL, follicular lymphoma, certain transformed lymphomas, primary mediastinal B-cell lymphoma, or high-grade B-cell lymphoma
• People whose lymphoma has come back or has not responded to treatment, such as: no remission or relapse after second-line or later chemotherapy; the cancer never responded to initial treatment; or the cancer came back after a stem cell transplant using the patient's own cells
• People who have at least one measurable area of cancer that doctors can monitor during the trial

For all participants (both B-ALL and NHL):

• People whose blood test results for liver function, kidney function, and bilirubin (a substance processed by the liver) fall within the ranges the trial requires (confirm with trial site for exact figures)
• People whose heart is pumping at or above the required level, as shown on a heart scan
• People with no active lung infection and whose blood oxygen level while breathing normal air is at or above 92%
• People whose doctors estimate they have a life expectancy of at least 3 months
• People who are well enough to carry out basic daily activities, as rated on a standard medical scale (ECOG score of 0, 1, or 2)
• People, or their legal guardians, who agree to take part and sign a consent form

Who may not be able to join:

For people with B-ALL only:

• People whose cancer has spread to areas outside the bone marrow, except where central nervous system involvement is confirmed to be well controlled
• People with a diagnosis of a specific related cancer called Burkitt's leukaemia/lymphoma or lymphoblastic crisis of chronic myeloid leukaemia
• People with inherited conditions affecting bone marrow function, such as Fanconi anaemia, Kostmann syndrome, or Shwachman syndrome

For people with NHL only:

• People whose cancer has spread to the brain or surrounding fluid, as shown by MRI or fluid testing
• People with widespread involvement of lymphoma throughout the gastrointestinal tract

For all participants (both B-ALL and NHL):

• People who have received radiotherapy, chemotherapy, or certain antibody-based treatments within one week before the screening stage of the trial
• People with a known allergy to any component of the cell therapy product used in this trial
• People who have previously received any CAR T-cell therapy or other gene-modified T-cell treatments
• People with moderate to severe heart failure, classified as Grade III or IV on a standard heart function scale
• People who have had a heart attack, heart procedure, stenting, or other serious heart condition within the past 12 months
• People with severe high blood pressure classified as Grade 3 or above on WHO guidelines
• People with a history of prolonged electrical activity in the heart (prolonged QT interval) or serious irregular heart rhythms
• People with a history of brain injury, loss of consciousness, epilepsy, or bleeding or blockage in the brain's blood vessels
• People with a severe active infection (not including simple urinary tract infections or common throat infections)
• People who have certain types of internal catheters or drainage tubes in place (some types of central line catheters are permitted — confirm with trial site)
• People with a history of another type of cancer, except for certain skin cancers fully removed by surgery, or certain other cancers that have been successfully treated with no signs of disease for at least two years (confirm with trial site)
• People with autoimmune diseases requiring treatment, immune deficiency conditions, or those who need immune-suppressing medicines
• People who currently have graft-versus-host disease (a condition that can occur after receiving cells or tissue from another person)
• People who have received a live vaccine within four weeks before screening
• People with a history of alcoholism, drug misuse, or mental illness
• People with active hepatitis B infection at a level above the threshold the trial requires, or people with hepatitis C, syphilis, or active CMV infection (those with lower-level hepatitis B may still be considered with appropriate antiviral treatment — confirm with trial site)
• People who are currently taking steroid medicines by mouth or injection (inhaled steroids may be permitted — confirm with trial site)
• People who have taken part in another clinical trial within the two weeks before screening
• People who are pregnant or breastfeeding, or people of childbearing potential who are unable or unwilling to use effective contraception during the trial (this applies regardless of gender)
• People with any other condition that the trial doctor believes could increase risk or affect the reliability of the trial results

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