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 aged 18 or older.
• People who are able to understand and sign a consent form approved by an ethics review board.
• People who have been diagnosed with a type of blood cancer called B-cell non-Hodgkin lymphoma (NHL), confirmed by a tissue sample, that tests positive for both CD19 and CD20 proteins (at least 5% positivity on testing).
• People whose lymphoma has remained active or returned after at least 2 rounds of chemotherapy treatment.
• People who have previously received a treatment called rituximab or a similar anti-CD20 antibody therapy.
• People who have either already had an autologous stem cell transplant (using their own stem cells) that did not work, or whose medical situation means a transplant of this kind is not an option for them.
• People with measurable disease detected within the past 8 weeks, based on tumour size standards called the Lugano classification, or confirmed bone marrow involvement shown by biopsy.
• People who have had brain and spinal fluid testing (MRI scan and lumbar puncture) showing no signs of the cancer having spread to the central nervous system.
• People with a general health and activity level rated 0 or 1 on a standard scale used by doctors (meaning fully active or able to carry out light activity).
• People with an expected survival of more than 12 weeks.
• People who are willing and able to have a central line (a type of tube placed in a large vein) inserted for receiving the study treatment.
• People who are able to attend all required study visits and follow-up appointments.
• People of childbearing potential or non-sterile males who agree to use effective contraception during the study and for at least 5 months after the last dose of the study drug.

Who may not be able to join:

• People with a known allergic reaction to any ingredient in the study medication, including serious reactions to sulfur-containing medicines.
• People with a known allergy to human albumin or a substance called dimethyl sulfoxide (DMSO).
• People with a serious uncontrolled medical condition that would make it unsafe to receive the study treatment.
• People with a history of significant autoimmune disease (such as lupus or autoimmune anaemia), or an active, uncontrolled autoimmune condition currently requiring high-dose steroid treatment (confirm with trial site for specific dose thresholds).
• People who have received a bone marrow or stem cell transplant from another person (allogeneic transplant), or CAR T-cell therapy from another person, within the past 6 months, or who are still receiving treatment for graft-versus-host disease.
• People who have received anti-CD19 or anti-CD20 antibody treatment within 4 weeks before the planned cell infusion.
• People who have received a live vaccine within 6 weeks before starting the preparatory chemotherapy phase of the trial.
• People who have received a donor organ transplant and are taking medicines to prevent rejection.
• People who have developed a high-grade blood cancer or lymphoma after a solid organ transplant.
• People whose lymphoma has spread to the central nervous system (brain or surrounding membranes).
• People with a non-cancer-related brain or nervous system condition, such as a history of stroke, epilepsy, or a degenerative neurological disease.
• People with a history of, or currently active, inflammatory bowel disease such as Crohn's disease or ulcerative colitis.
• People whose blood test results show that certain organs (such as the liver, kidneys, or bone marrow) are not functioning well enough, based on specific laboratory thresholds (confirm exact values with trial site).
• People with poorly controlled high blood pressure or a recent significant heart-related event (such as a heart attack or stroke) within the past 6 months, or certain ongoing heart conditions.
• People who have been taking systemic (whole-body) corticosteroids daily for more than 3 months at a dose equivalent to 10 mg or more of methylprednisolone per day (inhaled steroids are not included in this restriction).
• People currently taking any prescribed or herbal medicine known to interact badly with the study medications.
• People with HIV and a current CD4+ immune cell count below 500 cells per microlitre.
• People who are chronic carriers of hepatitis B and currently test positive for the hepatitis B surface antigen.
• People with another active cancer, other than certain common types of skin cancer (basal or squamous cell carcinoma).
• People who the trial investigator believes are unable or unwilling to follow the study requirements.
• People who are pregnant or breastfeeding. A negative pregnancy test is required at the screening stage and again within 48 hours before the preparatory chemotherapy begins.

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