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 have been diagnosed with a recurring T-cell blood or lymph node cancer, including T-ALL, T-LL, or certain types of T-cell non-Hodgkin Lymphoma (such as PTCL, ALCL, Mycosis fungoides stage IIB or higher, and several other related types).
• People whose cancer has come back after a previous stem cell transplant from a related donor (whether fully matched, partially matched, or half-matched), and whose original donor is available to donate blood again for manufacturing the experimental treatment.
• People who are considered medically suitable for another stem cell transplant, with a suitable donor already identified at an accredited transplant centre, and who are willing to proceed with a transplant if the treatment leads to complete remission.
• People whose cancer cells test positive for a protein called CD7, found on at least 20% of cancer cells, as confirmed by a certified laboratory.
• People aged 75 years old or younger.
• People with a haemoglobin level of at least 7.0 g/dL (which may be achieved through a blood transfusion).
• People with a life expectancy of more than 12 weeks.
• People who have access through the trial site to a specific type of virus-fighting immune cell line (EBV-specific T cells) that can be used if a particular virus becomes a problem during treatment (confirm with trial site).
• People whose liver function, kidney function, blood oxygen levels, and overall physical functioning meet the thresholds set by the trial (confirm specific values with trial site).
• People who have recovered from the side effects of any previous cancer treatments at least one week before starting the trial treatment.
• People who are at least 60 days past their previous stem cell transplant at the time of receiving the trial treatment.
• People who are sexually active and willing to use effective contraception during the study and for 6 months afterward; male partners are asked to use a condom.
• People who have provided written informed consent, or whose legal representative has done so on their behalf.

Who may not be able to join:

• People who have an active infection currently requiring antibiotic treatment (at the procurement stage).
• People with an active HIV infection.
• People with a history of another cancer, unless it was non-melanoma skin cancer, in-situ breast cancer, or in-situ cervical cancer — or unless the other cancer was fully treated with the intention of cure at least 2 years before joining the trial.
• People currently taking part in another clinical trial or who have received a cancer vaccine within the past 4 weeks.
• People with a known history of severe allergic reactions to products containing mouse-derived proteins.
• People who are pregnant or breastfeeding.
• People whose tumour is located in a position where swelling could block the airway, as determined by the treating doctor.
• People with a significant active infection, or uncontrolled reactivation of certain viruses including EBV, CMV, adenovirus, BK virus, or HHV-6.
• People with moderate to severe graft-versus-host disease (GVHD), a condition where transplanted cells attack the body's own tissues.
• People currently taking corticosteroid medicines at a dose higher than 0.5 mg/kg of prednisone or equivalent.
• People who have received immune-suppressing treatment for GVHD within the 28 days before the planned treatment infusion.
• People who have received a donor lymphocyte infusion (a type of immune cell therapy) within the 28 days before the planned treatment infusion.
• People with certain heart conditions, including uncontrolled irregular heart rhythm, a heart attack within the past 12 months, certain abnormal heart rhythm patterns, reduced heart pumping function below specified thresholds, significant fluid around the heart, or advanced heart failure (confirm specific thresholds with trial site).
• People with certain brain or nervous system conditions, including active disease in the fluid around the brain and spinal cord (CNS-3 disease), uncontrolled seizures, a stroke or brain bleed within the past 12 months, dementia, certain brain coordination disorders, or autoimmune conditions affecting the brain.

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