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.
• People who have a blood cancer involving CD19-positive cells (a specific marker found on cancer cells), confirmed by laboratory testing, including types such as non-Hodgkin lymphoma, acute lymphoblastic leukemia, or chronic lymphocytic leukemia/Richter's syndrome.
• People whose cancer has come back or stopped responding to treatment, and who have already tried at least 2 previous treatments that did not work.
• People who are well enough to carry out basic daily activities, as measured by a standard medical scoring system (confirm with trial site).
• People whose doctors estimate they have a life expectancy of more than 12 weeks.
• People who are willing to be followed up for 15 years as part of a separate long-term study linked to this trial.
• People whose blood counts, liver function, and kidney function meet minimum levels set by the trial (confirm with trial site for specific values).
• People who are not pregnant, are post-menopausal, or have had a permanent surgical procedure that prevents pregnancy — with specific requirements depending on age (confirm with trial site).
• People who can become pregnant, and people whose sexual partners can become pregnant, who agree to use a highly effective form of contraception during the trial.
• People who have recovered sufficiently from any side effects of previous cancer treatments, or whose remaining side effects are considered stable by their treating doctor.
• People with suitable vein access for blood draws and infusions.
• People who are able to understand the study information and agree to sign a consent form.
• Before the preparatory chemotherapy step (called lymphodepletion) begins, additional checks must be confirmed, including that the CAR-T cells have been successfully manufactured, that there is no active infection, that kidney function still meets the required level, and that the person's overall health has not significantly worsened (confirm with trial site).
• Before the CAR-T cell infusion step, further checks must confirm that the person's health has not significantly worsened and that required waiting periods after other medications have been followed (confirm with trial site).

Who may not be able to join:

• People who have had a stem cell transplant or CAR-T cell therapy within 6 weeks of the planned CAR-T infusion date.
• People who currently have an active infection that requires treatment with systemic medications.
• People with a history of an autoimmune disease (such as rheumatoid arthritis or lupus) who have needed immune-suppressing medication within the past 6 months.
• People who are currently pregnant or breastfeeding.
• People who are currently taking part in another clinical trial involving an experimental treatment.
• People who have not completed required waiting periods after certain medications (confirm with trial site for specific medications and timeframes).
• People who have had major surgery within 4 weeks before starting the study, or who have not fully recovered from major surgery.
• People who have been diagnosed with another cancer within the past 2 years, with some exceptions for certain low-risk or fully treated cancers such as some skin cancers, early-stage breast, bladder, or cervical cancers, or low-grade prostate cancer (confirm with trial site).
• People with known cancer spread to the brain or the area surrounding the brain, unless it was treated with radiation or surgery, has been stable for at least 4 weeks, and the person has no neurological symptoms and is not taking steroid medications.
• People with serious heart conditions, including severe heart failure, unstable chest pain, dangerous heart rhythm problems, a recent stroke or heart attack within the past 3 months, a specific type of abnormal heart electrical reading, a known inherited heart condition, reduced heart pumping function below a set level, or uncontrolled high blood pressure.
• People with any other condition that the trial doctor believes would make participation unsafe or difficult to manage.
• People with active tuberculosis, active hepatitis B, active hepatitis C, or HIV infection (some exceptions may apply for people with past resolved hepatitis B or hepatitis C — confirm with trial site).
• People with medical, psychiatric, thinking, or other conditions that might prevent them from understanding the trial information, giving consent, or following the trial procedures.
• People who have previously had a severe allergic reaction to the trial treatment or any of its ingredients.
• People currently taking medications that are not permitted during this trial, unless the required waiting period after stopping those medications has passed (confirm with trial site).
• People with a significant history of neurological conditions affecting the brain or nervous system, such as epilepsy, seizure disorders, uncontrolled stroke disease, severe brain injury, dementia, or Parkinson's disease.

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