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:

• Adults aged 18 or older (for the lymphoma group) or young people aged 12 or older (for the ALL group) at the time of signing the consent form.
• The patient or their legal guardian is able to understand and voluntarily sign a consent form before any study procedures begin.
• People who are able to attend all required study visits and follow all study requirements, and who agree to ongoing follow-up for up to 15 years, as required by gene therapy regulations.
• People whose cancer cells have been confirmed to carry a specific protein called CD19 or CD22, detected through laboratory testing.
• People who are willing to use highly effective contraception during treatment and for 12 months after receiving the study treatment (applies to women who could become pregnant, and men whose partners could become pregnant).
• People who agree not to donate blood during the study and for one year after finishing the study treatment.
• People with a type of blood cancer called ALL or lymphoma/CLL that has come back or stopped responding to treatment, and whose cancer cells carry CD19 or CD22, meeting one of the following:
  • People with lymphoma (of specific types listed under WHO classification) that has returned or stopped responding after two or more previous treatments, including at least one approved CAR-T cell or bispecific antibody treatment, or where those treatments are not suitable.
  • People with CLL (a type of blood cancer) where all established approved treatments, including BTK inhibitor therapy, have stopped working.
  • People with lymphoma who have been recommended for a stem cell transplant by their medical team but are not able or willing to have one, including those whose disease is too active for transplant right now (these people may join as a step toward a future transplant).
  • People with lymphoma that has returned after a stem cell transplant, or after treatment targeting CD19 or CD22, where CD19 or CD22 expression has been confirmed after the relapse.
  • People with lymphoma that has spread to the central nervous system (brain and spinal cord), if that disease is well controlled at the time of joining the trial.

Who may not be able to join:

• People who received certain treatments in the 7 days before the cell collection procedure (called leukapheresis), including experimental drugs, immune-suppressing medications, plasma exchange, major surgery, radiation therapy (other than local treatment), anti-cancer drugs, or high-dose steroid medications above a specified level.
• People whose general health and functioning is rated above a certain level of decline on a standard medical scale (ECOG score above 3) (confirm with trial site).
• People showing signs of certain serious blood or lung complications, or active graft-versus-host disease at the time of screening.
• People with a significant history of certain brain or nervous system conditions, such as epilepsy, stroke, severe brain injury, dementia, Parkinson's disease, psychosis, or certain other neurological disorders.
• People whose blood test results fall outside certain required ranges, including low levels of certain white blood cells or platelets, reduced kidney function, high calcium levels, abnormal liver enzyme levels, abnormal bilirubin levels, or abnormal blood clotting results — or people who require ongoing blood-thinning medication.
• People who do not have suitable veins or blood vessel access for the cell collection procedure.
• People whose heart pumping function, measured by a heart scan, is below a certain level (left ventricular ejection fraction below 45%).
• People with a history of severe heart failure, serious heart muscle disease, unstable chest pain, a heart attack, or dangerous heart rhythm problems within the past three months.
• People whose blood oxygen levels fall below 90% when breathing normal room air.
• People with a history of a primary immune system deficiency condition.
• People who test positive for HIV, or who have uncontrolled hepatitis B or C, or active hepatitis A.
• People with an ongoing infection or infestation that, in the treating doctor's judgement, could pose a serious health risk if they joined the trial.
• People with a cancer other than the one being treated in this trial, unless that other cancer has been stable and controlled for at least one year — with some exceptions for certain non-invasive skin or early-stage cancers as specified in the trial protocol.
• People who are pregnant, breastfeeding, or planning to become pregnant during the study.
• People with a known allergy or sensitivity to any ingredient in the study treatment (MB-CART2219.1), or to the preparatory medications cyclophosphamide, fludarabine, or tocilizumab.
• People with any significant medical condition, abnormal test result, or psychiatric illness that, in the medical team's assessment, would make participation unsafe or affect the reliability of the study results.

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