Phase 2 Lymphoma 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:

• The person joining (or their legal guardian) must understand the study and agree to take part by signing a consent form.
• People aged 12 to 65 years old at the time of signing the consent form.
• People expected to live for at least 12 weeks.
• People who are reasonably functional in daily life, as assessed by a standard medical scale (ECOG score of 0–2) at the time of signing the consent form.
• People who have been diagnosed with relapsed or treatment-resistant B-cell acute lymphoblastic leukaemia (a type of blood cancer that has come back or stopped responding to treatment), and who have more than 5% abnormal cancer cells in the bone marrow, cancer cells detected in the fluid around the spine, or measurable tumour growths in the body.
• People whose cancer cells have tested positive for certain proteins called CD19 or CD22, confirmed by laboratory testing of bone marrow, blood, spinal fluid, or tumour tissue.
• For the second phase of the trial specifically: people whose B-cell leukaemia has already been treated with certain prior immunotherapies — blinatumomab, inotuzumab ozogamicin, or a single-target CAR-T cell therapy — and has not responded or has relapsed.
• People whose liver is functioning well enough, with liver enzyme and bilirubin levels within acceptable ranges as measured by blood tests.
• People whose kidneys are functioning well enough, based on blood test results (with specific acceptable levels varying by age and sex).
• People whose blood oxygen level is above 92% while breathing normal air.
• People who are able to have children and are willing to use effective contraception from the time of signing the consent form until 2 years after receiving the study treatment.
• Women who could become pregnant must have a negative blood pregnancy test at the screening stage.

Who may not be able to join:

• People with a history of significant brain or nervous system conditions, including epilepsy, paralysis, speech difficulties, stroke, severe brain injury, dementia, Parkinson's disease, or nerve damage.
• People who have needed whole-body (systemic) treatments to suppress their immune system for an autoimmune disease — such as Crohn's disease, rheumatoid arthritis, lupus, or psoriasis — within the 2 years before signing the consent form.
• People who have an active, uncontrolled infection requiring antibiotic, antiviral, or antifungal treatment at or within 4 weeks before the cell collection procedure.
• People who test positive for certain infections, including: active hepatitis B (with detectable virus in the blood), hepatitis C (with detectable virus in the blood), HIV, cytomegalovirus (CMV), Epstein-Barr virus (EBV), or syphilis.
• People with significant heart conditions, including a prolonged heart rhythm interval on an ECG, moderate-to-severe heart failure, unstable chest pain or a heart attack within the past 6 months, reduced heart pumping function, poorly controlled high blood pressure, or serious irregular heart rhythms.
• People who have had a severe allergic reaction to any ingredient in the study treatment.
• People who have received another experimental treatment or cancer therapy within 4 weeks before the cell collection procedure (or longer, depending on the specific drug).
• People who have had extensive radiation therapy within 4 weeks before signing the consent form (with some exceptions for limited palliative radiation to non-target areas).
• People who still have significant side effects from previous cancer treatments that have not resolved to near-baseline levels, except for hair loss or skin colour changes.
• People who require moderate-to-high doses of corticosteroids (such as prednisone at 10 mg/day or more) or other immune-suppressing medicines within 3 days before the cell collection procedure or during the study, with some specific exceptions allowed (such as low-dose steroids, inhaled or topical steroids, or steroids used to prevent allergic reactions).
• People who have had major surgery within 4 weeks before signing the consent form, or who are expected to need major surgery during the trial.
• People with a history of active tuberculosis within the past year (those with tuberculosis more than a year ago may be considered if the treating doctor confirms there is no sign of active disease).
• People who have had another type of cancer within the past 5 years, with exceptions for certain early-stage or skin cancers that have been fully treated.
• People who have received a live or inactivated vaccine within 4 weeks before signing the consent form, or who plan to receive one during the screening period.
• People who are pregnant or breastfeeding.
• People with any other medical condition or situation that, in the treating doctor's judgement, would make participation unsafe or unsuitable.

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