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:

• People aged 18 to 69 years, of any gender
• People who have been diagnosed with T-cell acute lymphoblastic leukemia or lymphoblastic lymphoma (T-ALL/LBL) according to specific clinical guidelines
• People who have been diagnosed with acute myeloid leukemia (AML) according to specific clinical guidelines
• People whose cancer cells have tested positive for a marker called CD7
• People whose bone marrow test shows at least 5% blast cells (abnormal cells) at the time of screening
• People whose AML has come back or stopped responding to treatment, meeting at least one of these conditions: the disease did not go into remission after two rounds of standard chemotherapy; the disease came back within 12 months of remission; the disease came back after 12 months but did not respond to further chemotherapy; the disease has relapsed two or more times; or the disease came back after a stem cell transplant
• People whose T-ALL/LBL has come back or stopped responding to treatment, meeting at least one of these conditions: the disease did not go into remission after two rounds of standard chemotherapy or after multiple rounds of rescue chemotherapy; the disease came back within or after 12 months of remission and did not respond to further treatment; or the disease came back after a stem cell transplant or after CAR-T cell therapy targeting the same marker
• People with other CD7-positive blood cancers that have come back or stopped responding to treatment
• People whose kidneys, liver, and heart are functioning within acceptable ranges as measured by specific tests (confirm with trial site for exact values)
• People whose heart pumping function (ejection fraction) is at least 50% as shown by an echocardiogram (heart ultrasound)
• People whose blood oxygen level is at least 92%
• People whose expected survival is more than 3 months
• People with a general health and activity level rated 0, 1, or 2 on a standard medical scale (meaning able to carry out normal daily activities, with at most some limitation)
• People, or their legal guardians, who are willing to participate and sign a consent form

Who may not be able to join:

• People diagnosed with a specific type of leukemia called acute promyelocytic leukemia (APL)
• People with certain inherited conditions that affect bone marrow function, such as Fanconi's anaemia, Kostmann's syndrome, or Shwachman syndrome, or any other known bone marrow failure syndrome
• People with leukemia that has spread to the central nervous system (brain and spinal fluid) and is not currently under control
• People who have received certain recent anti-cancer treatments before joining, including: systemic chemotherapy within the past week (other than specific preparatory treatment); certain antibody-based therapies received too recently before screening; or a procedure called donor lymphocyte infusion within the past 6 weeks
• People with a serious active infection that is not under control at the time of screening
• People with a significant heart condition, including severe heart failure, a heart attack or heart procedure within the past 12 months, unstable chest pain, a notably prolonged electrical signal in the heart (QT interval greater than 480ms), or a serious irregular heartbeat
• People who have had a brain injury, loss of consciousness, epilepsy, or a brain blood vessel condition within the past six months that required medication
• People with certain active viral infections at screening, including high levels of hepatitis B virus, hepatitis C antibodies, HIV, syphilis, or a virus called EBV above normal levels
• People who need to take steroid medications (taken throughout the whole 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 deficiency conditions, or people who need immunosuppressive medications
• People who have had a serious immune reaction related to a previous stem cell transplant (called graft-versus-host disease) within the past 4 weeks
• 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 are unwilling or unable to use effective contraception for at least one year after treatment; also people who plan to father or conceive a child within one year after treatment
• People with any other condition that the trial doctor believes could increase risk or affect the trial results

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