Phase 2 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 who are able to give their own agreement to take part (if old enough under local law), or who have a parent or legal guardian who has signed and dated a consent form before any study procedures begin.
• People who have been confirmed by tissue testing to have a mature B-cell blood cancer that carries the CD19 and/or CD20 marker, including types such as Burkitt lymphoma/leukemia, diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma, Burkitt-like lymphoma with an 11q change, aggressive mature B-cell lymphoma, or other rare aggressive B-cell lymphomas (the last category requires approval from the study sponsor).
• People whose B-cell cancer has come back or stopped responding after one or more previous treatments, or did not respond to the first treatment given.
• Children and adolescents between 6 months and under 18 years of age.
• People who weigh at least 6 kilograms.
• People who have disease that can be measured on scans, based on international pediatric lymphoma response guidelines (previously treated areas can only be counted if scans show the disease has grown back there).
• People who can provide a tissue sample — either stored or freshly collected — from a recent relapse or from the original diagnosis (if the disease never responded to treatment), collected within the last 2 years and preferably within the last 2 months, for central review to confirm the diagnosis.
• People with a physical functioning score of 60 or above on the age-appropriate scale (Karnofsky scale for those aged 16 and over, Lansky scale for those under 16).
• People whose bone marrow blood counts meet all of the following levels as tested by a local laboratory: neutrophil count above 1000 per microlitre, platelets at or above 50,000 per microlitre, haemoglobin at or above 8.0 g/dL, and lymphocyte count above 100 per microlitre.
• People whose organ function meets all of the following: kidney filtering rate above 29 mL/min (by the Schwartz formula), liver enzyme levels (AST and ALT) no more than 5 times the upper normal limit for their age, bilirubin below 1.5 times the upper normal limit (or total bilirubin below 4 mg/dL for those with Gilbert's Syndrome), resting blood oxygen level of 91% or above on room air, and no or only mild breathlessness.
• Female participants who could become pregnant must be willing to have pregnancy tests before receiving the study treatment.
• Sexually active participants must be willing to use highly effective contraception: females must use two methods (one highly effective method such as hormonal contraception, an IUD, or a vasectomised partner, plus one barrier method) from enrolment until at least 12 months after receiving the study treatment; males must use a condom during intercourse from enrolment through at least 12 months after treatment to avoid fathering a child and to prevent the study treatment from being passed through semen, and must not donate sperm during this period.
• Females must agree not to breastfeed or donate eggs from enrolment until at least 12 months after receiving the study treatment.
• People who are willing to have a blood cell collection procedure (leukapheresis) without prior stem cell mobilisation.
• People who, in the investigator's judgement, are able to follow all study procedures, take required medications, and attend all assessments.

Who may not be able to join:

• People who are currently receiving active treatment for cancer, including participation in another clinical trial for an investigational drug or device (pre-enrolment therapy and radiotherapy are exceptions, but at least one measurable area of disease must remain after pre-enrolment therapy for lymphoma patients).
• People who have previously received a donor (allogeneic) stem cell transplant.
• People who received their own stem cells back (autologous stem cell transplant) less than 120 days before signing consent.
• People who had major surgery within 2 weeks before the blood cell collection procedure, have not fully recovered from a previous surgery, or have a major surgery planned during the expected study period.
• People whose B-cell cancer developed as a complication of a previous organ or stem cell transplant (post-transplant lymphoproliferative disorder).
• People with a known allergy to any ingredient in the study treatment or to any other medications required by the study protocol, such as the drugs used to prepare the body before treatment.
• People who have active lymphoma involvement in the fluid around the brain or spinal cord at the time eligibility is confirmed.
• People with a history or current presence of an autoimmune disease affecting the brain or nervous system, such as multiple sclerosis or optic neuritis.
• People who have HIV infection.
• People with active or previous hepatitis B or C infection, unless treatment has been completed and confirmed by a negative PCR test.
• People with a Treponema pallidum infection (the bacteria that causes syphilis).
• People with an active COVID-19 (SARS-CoV-2) infection.
• People with HTLV 1/2 virus infection.
• People with a serious active fungal, viral, or bacterial infection currently requiring systemic treatment.
• People with clinically significant seizures, in the investigator's judgement.
• People who have had a stroke within the 12 months before the blood cell collection procedure.
• People with reduced heart function, specifically a fractional shortening below 28% or a left ventricular ejection fraction below 50% on heart imaging.
• People with an inherited condition associated with bone marrow failure, such as Fanconi anaemia, Kostmann syndrome, or Shwachman syndrome, or any other known bone marrow failure syndrome.
• People who are pregnant or breastfeeding.
• Sexually active people who are not willing to use the highly effective contraception methods described in the inclusion criteria.
• People who have had another cancer within the past 3 years that required systemic treatment.
• People who have another medical, psychological, or social condition that, in the investigator's opinion, could affect their safety or the reliability of study results.
• People who have received a live virus vaccine within 6 weeks before giving consent to join the study.
• People who have previously received an approved anti-CD19 or anti-CD20 CAR-T cell therapy less than 100 days before giving consent to join the study.

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