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 who are willing and able to sign a consent form agreeing to take part
• People who are 18 years of age or older at the time of signing the consent form
• People whose general health and ability to carry out daily activities meets a certain minimum standard (rated on a scale used by doctors to assess cancer patients)
• People who have been diagnosed with one of the following types of non-Hodgkin's lymphoma that has come back or stopped responding to treatment:
  • Follicular Lymphoma (grades 1, 2, or 3a) that has returned or not responded after at least 2 previous treatments
  • Marginal Zone Lymphoma (nodal or extranodal) that has returned or not responded after at least 2 previous treatments
  • Diffuse large B-cell lymphoma (including certain related subtypes) that has returned or not responded after at least 2 previous treatments, OR has come back after a stem cell transplant using the patient's own cells, OR where that type of transplant is not suitable
  • Mantle cell lymphoma that has progressed or not fully responded to previous treatment, with prior treatment that must have included specific chemotherapy types, an anti-CD20 antibody therapy, and a type of targeted therapy called a BTK inhibitor
• People whose lymphoma is measurable by standard tests
• People with an adequate level of certain white blood cells (lymphocytes) in the week before the cell collection procedure
• People with adequate bone marrow function, shown by sufficient levels of neutrophils and platelets without recent supportive medication
• People whose heart pumps with at least 40% efficiency (measured by a heart scan)
• People with adequate liver function, shown by blood test results within acceptable ranges
• People with adequate kidney function, measured by a formula using blood test results
• People who are able and willing to use reliable contraception (hormonal, barrier methods, or abstinence) — women of childbearing potential for up to 1 year after the cell infusion, and men with partners who could become pregnant for up to 6 months after the last infusion
• People who are able and willing to attend all required study visits and follow all study requirements

Additional criteria that must be met before starting treatment (before chemotherapy preparation and cell infusion):

• General health and daily activity ability still meets the minimum standard at the time of starting treatment
• No active, uncontrolled infection in the body; if a fever is present, blood cultures must show no infection for 48 hours and the person must be on appropriate antibiotic treatment
• Blood oxygen level above 92% while awake and breathing room air
• No additional cancer treatments received since the cell collection procedure (steroids at very low doses may be permitted)

Who may not be able to join:

• People who have received any experimental cell therapy within 8 weeks before the cell collection procedure
• People who have had systemic cancer treatment within 1 week (or within 5 half-lives of that treatment, whichever is shorter) before the cell collection procedure (low-dose steroids may be permitted)
• People who have received a type of therapy called a bispecific T-cell engager within 6 months before the cell collection procedure
• People who have received a chemotherapy called bendamustine within 6 months before the cell collection procedure
• People currently taking ongoing immunosuppressant medications (such as cyclosporine or higher-dose steroids); occasional use of topical, inhaled, or nasal corticosteroids is generally permitted
• People currently receiving immunosuppression treatment following a previous bone marrow transplant using another person's cells, or who are less than 12 weeks from that type of transplant
• People with active lymphoma affecting the brain or central nervous system
• People with serious other medical conditions that the lead doctor believes would put them at undue risk or interfere with the study (for example, severe liver disease or serious recent injury)
• People with an active, uncontrolled bacterial, viral, or fungal infection
• People with a history of severe heart failure (classified as Class III or IV) or a certain type of heart muscle disease
• People who have had unstable chest pain, a heart attack, or a serious heart rhythm problem requiring treatment within the past 3 months
• People with certain blood vessel conditions, such as a history of stroke or peripheral vascular disease requiring blood-thinning medication
• People who have had a blood clot in the lungs or legs within the past 6 months and are still requiring blood-thinning treatment
• People with a second cancer that has required treatment in the last 3 years or is not fully cleared; certain skin cancers that have been successfully treated, or prostate cancer managed only with hormone therapy, may be exceptions (confirm with trial site)
• Women who are pregnant or breastfeeding
• People who have previously received a CAR T-cell therapy directed at a target called CD19 (this applies only to one specific part of the trial)

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