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:

• You have a type of blood cancer called B-cell ALL (Arm A) that has come back or stopped responding to standard chemotherapy, and no other curative treatment is available — previous CAR-T cell therapy targeting CD19 is allowed but not required.
• OR you have a type of blood cancer called T-cell ALL (Arm B) that has come back or stopped responding to standard chemotherapy, and no other curative treatment is available.
• You must be considered suitable for a stem cell transplant from a donor, and willing to have one if the CAR-T treatment puts your cancer into full remission and your doctor thinks it is the best option.
• For Arm B only, there must be a suitable half-matched (haploidentical) donor available.
• You must have a reasonable level of physical function, measured by standard scoring tools appropriate for your age (confirm with trial site).
• Your doctors expect you to live for more than 12 weeks.
• Your blood counts (white cells, platelets, and lymphocytes) must meet minimum levels, unless low counts are believed to be caused by the leukemia itself and may improve with treatment.
• Your kidneys, liver, lungs, and heart must be working well enough to take part.
• You must have suitable veins and no medical reason preventing a blood-collection procedure called leukapheresis.
• If you have a seizure disorder, you may still be eligible if your seizures are well controlled with medication.
• You (or your parent, guardian, or legal representative) must be able to give written consent to take part.

Who may not be able to join:

• You have taken part in another clinical trial in the past 4 weeks.
• You have an active infection requiring treatment, including certain serious viral infections or fungal infections that are not under control.
• You have significant heart problems, including reduced heart function on an ultrasound scan or a notable fluid build-up around the heart.
• You have leukemia that has spread to the brain and spinal fluid at a severe level (CNS-3), or seizures that are not well controlled.
• You are currently taking medications that suppress the immune system, with the exception of a low dose of steroid (prednisone 10 mg/day or equivalent), within 7 days before joining the trial.
• Your kidney function is too low, or your liver values are too high (unless a specific harmless condition called Gilbert's syndrome is the cause).
• You have any other medical condition that the lead doctor believes could affect the safety or results of the trial.
• You are pregnant or breastfeeding.
• If you are sexually active and could become pregnant, you must be willing to use effective contraception for at least 12 months after treatment and until CAR-T cells are no longer detectable on two separate tests.
• If you are a sexually active male, you must use a condom during sex for at least 12 months after treatment and until CAR-T cells are no longer detectable on two separate tests.

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