Early 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:

• A person (male or female) who is over 18 and no older than 70 years of age
• People who have been diagnosed with a type of B-cell lymphoma (either a slow-growing type or diffuse large B-cell lymphoma) that has come back or stopped responding to previous treatments
• People whose cancer has met one of the following situations: received at least one standard treatment and one additional treatment course (including a CD20-targeting drug and at least two regimens, one of which included a specific chemotherapy type called anthracyclines); disease that stayed stable for 12 months or less, or kept getting worse during treatment; cancer that came back after a stem cell transplant, or where a stem cell transplant is not possible; or a specific aggressive type of lymphoma (double-hit or triple-hit) that did not respond to second-line therapy
• People whose cancer cells test positive for a protein called CD19, confirmed by laboratory testing
• People who have had prior CD19 CAR-T cell therapy, provided at least one month has passed since that treatment, or people who have completed a required waiting period after other biological therapies
• People who have at least one measurable area of disease that can be tracked on scans at the start of the trial
• People expected to live for more than 12 weeks
• People with a general health performance score of 0 or 1 on the ECOG scale (a measure of how much a person's illness affects daily activity), with some exceptions for certain nervous system involvement, to be assessed by the trial doctor
• People whose blood counts meet specific minimum levels (tested within 24 hours before cell collection, without recent transfusions or certain growth factor treatments in the 7 days before)
• People whose liver, kidney, and other organ function test results fall within the acceptable ranges set by the trial
• People whose breathing is only mildly affected or not at all, and whose blood oxygen level is above 91% in normal indoor air
• People whose heart is pumping with sufficient strength, confirmed by heart imaging tests showing at least 45% pumping function
• People who have stopped steroid medications (at therapeutic doses) at least 2 weeks before receiving the trial treatment; low-level replacement doses may be permitted
• People who have stopped any immune-suppressing medications at least 4 weeks before signing consent
• People who have stopped all anti-cancer treatments (other than the pre-treatment chemotherapy used in this trial) at least 2 weeks before receiving the trial treatment
• People who have stopped any treatments directed at the central nervous system at least 1 week before receiving the trial treatment
• People who have recovered from serious side effects of previous treatments (minor or stable lasting side effects, such as hair loss, may be acceptable at the trial doctor's discretion)
• People who agree to use effective contraception for at least 12 months after receiving the trial treatment, and until two consecutive tests confirm no remaining trial cells in the body; this applies to women of childbearing age and all male participants
• All participants (or their legal guardians) must sign a consent form approved by an Ethics Committee before any screening begins

Who may not be able to join:

• People who have a current or past nervous system condition not caused by their cancer, such as seizures, stroke, dementia, cerebellar disease, or an autoimmune condition affecting the brain or nervous system
• People who received chemotherapy (other than the specific pre-treatment chemotherapy used in this trial) within 2 weeks before receiving the trial treatment
• People who have participated in another clinical trial within 30 days before enrolling
• People with active hepatitis B or hepatitis C infection, based on specific blood test results
• People who test positive for HIV or syphilis
• People with a serious, uncontrolled infection (bacterial, viral, or fungal) that is life-threatening at the time of treatment
• People who have had unstable chest pain (angina) or a heart attack in the 6 months before signing consent, or uncontrolled blood clots, major bleeding, or deep vein blood clots in the 12 months before signing consent
• People with a history of another cancer, unless it was a fully treated skin cancer (basal or squamous cell), a cervical or breast cancer that was treated and has shown no signs of return for at least 3 years, or a cancer that was completely removed and has been in full remission for at least 5 years
• People who are pregnant or breastfeeding, or who have a positive pregnancy test
• People with a history of a prolonged heart rhythm problem (QT interval prolongation) or serious heart disease
• People who test significantly positive for a certain immune response (called ADA/FMC63) before signing consent (weakly positive results would be discussed with the trial doctor)
• People who the trial doctor determines should not participate for any other medical or safety reason

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