Phase 2 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:

• People aged 18 or older but under 70, of any gender
• People diagnosed with a type of blood cancer called T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL), confirmed using standard medical guidelines
• People diagnosed with a type of blood cancer called acute myeloid leukemia (AML), confirmed using standard medical guidelines
• People whose cancer cells have tested positive for a protein called CD7
• People whose bone marrow test shows at least 5% abnormal (blast) cells at the time of screening
• People with AML that has come back or has not responded to treatment, meeting at least one of these conditions: the cancer did not go into remission after two rounds of standard chemotherapy; it came back within 12 months of remission; it came back after 12 months but did not respond to further chemotherapy; it has relapsed two or more times; or it came back after a stem cell transplant
• People with T-ALL/LBL that has come back or has not responded to treatment, meeting at least one of these conditions: the cancer did not go into full remission after two rounds of standard chemotherapy or further rescue chemotherapy; it relapsed and did not respond to one or more further treatment cycles; or it came back after a stem cell transplant or after a prior CAR-T cell therapy targeting the same protein
• People with other CD7-positive blood cancers that have come back or have not responded to treatment
• People whose kidneys, liver, and heart are functioning within acceptable ranges as measured by specific blood and imaging tests (confirm with trial site for exact values)
• People whose heart pumping function (left ventricular ejection fraction) is at least 50%
• People whose blood oxygen level, measured by a finger sensor, is at least 92%
• People whose expected survival is more than 3 months
• People with a general health performance score of 0, 1, or 2 on a standard medical scale (confirm with trial site)
• People, or their legal guardians, who voluntarily agree to take part and sign a consent form

Who may not be able to join:

• People diagnosed with a specific subtype of leukemia called acute promyelocytic leukemia (APL)
• People with certain inherited conditions affecting the bone marrow, such as Fanconi anemia, Kostmann syndrome, or Shwachman syndrome
• People with leukemia that has spread to the central nervous system (brain and spinal fluid) and is not under control
• People who have received certain cancer treatments too recently before the trial, including systemic chemotherapy within 1 week, certain antibody-based therapies within a defined recent period, or donor lymphocyte infusion within 6 weeks (confirm with trial site for exact timeframes)
• People with a serious, active infection that is not under control at the time of screening
• People with significant heart conditions, including severe heart failure, a heart attack or heart procedure within the past 12 months, unstable chest pain, a significantly prolonged heart rhythm interval on an ECG, or other serious heart rhythm problems
• People who have had a serious brain or neurological condition such as a significant head injury, seizures, stroke, or brain bleeding, and who needed medication for it within the past six months
• People with certain infections detected through blood tests, including high levels of active hepatitis B, hepatitis C antibodies, HIV antibodies, syphilis, or certain Epstein-Barr virus markers
• People who need to use steroid medications (taken throughout the body, not just inhaled or applied to the skin) during or around the time of the CAR-T cell treatment
• People with autoimmune diseases requiring treatment, immune system deficiencies, or a need for ongoing immune-suppressing medications
• People who have had a serious complication called graft-versus-host disease (a reaction following a transplant) within the 4 weeks before screening
• People with a known allergy to any ingredient in the cell therapy product
• People who are pregnant, breastfeeding, or who are able to have children and cannot use effective contraception for at least one year after treatment; this applies to both male and female participants and includes male participants or their partners who plan to conceive within one year of treatment
• People with any other condition that the trial doctor believes could put them at risk or affect the trial results

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