Phase 2 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 have been diagnosed with one of the following B-cell blood cancers that has come back or stopped responding to treatment, and whose cancer cells test positive for a protein called BAFF-R: Mantle Cell Lymphoma (MCL), Chronic Lymphocytic Leukaemia (CLL), Diffuse Large B-Cell Lymphoma (DLBCL), Follicular Lymphoma (FL), Marginal Zone Lymphoma (MZL), or Waldenström Macroglobulinaemia (WM).
• People whose cancer diagnosis was confirmed according to recognised international guidelines (NCCN B-Cell Lymphoma Guidelines).
• People who have at least one measurable area of disease (a lesion at least 1.5 cm in size), or whose bone marrow testing shows lymphoma involvement.
• People who have already received prior treatment with CD19-targeted therapies may still be considered.
• For MCL: people who have received at least 2 prior lines of treatment, including an anti-CD20 antibody therapy and a BTK inhibitor (a specific type of targeted drug).
• For CLL: people who have received at least immune-chemotherapy and whose disease has stopped responding to both a BTK inhibitor and a BCL2 inhibitor.
• For DLBCL: people who have received at least 2 prior lines of treatment including anthracycline-based chemotherapy and an anti-CD20 antibody, or whose disease did not respond to or came back within 12 months of initial standard treatment.
• For FL (Grade 1–3a): people who have received at least 2 prior lines of treatment including an anti-CD20 antibody, or whose disease came back within 24 months of initial treatment.
• For MZL: people who have received at least 2 prior lines of treatment including an anti-CD20 antibody, or whose disease came back within 24 months of initial treatment.
• For WM: people who have received at least 2 prior lines of treatment including both an anti-CD20 antibody and a BTK inhibitor, or whose disease came back within 24 months of initial treatment.
• People aged 18 to 75 years (any gender).
• People whose doctors expect them to live for at least 12 weeks.
• People whose liver and kidney function blood test results fall within the ranges specified by the trial.
• People who are reasonably well and able to carry out daily activities, as measured by a standard medical scale (ECOG score of 0 or 1).
• People whose heart is pumping well enough (heart pumping function of at least 50%) and whose blood oxygen level is above 91%.
• People who agree to use effective contraception from the time of signing the consent form until one year after treatment.
• People who are not pregnant at the time of screening (a pregnancy test will be required for those who could become pregnant).
• People who voluntarily agree to take part and sign a consent form.

Who may not be able to join:

• People who have had an allergic reaction to any ingredient in this type of cell therapy product.
• People who have had a serious complication called graft-versus-host disease (a condition that can occur after certain transplants) at a significant level, or who have needed systemic treatment for this condition in the 4 weeks before joining.
• People who have received a live vaccine in the 4 weeks before joining.
• People who have a brain or nervous system condition unrelated to their lymphoma, such as epilepsy, stroke, Alzheimer's disease, or certain psychiatric disorders (confirm with trial site for cases involving lymphoma affecting the nervous system or digestive tract).
• People who have a serious active infection (other than simple urinary tract infections or bacterial throat infections), or who are currently receiving antibiotics through a drip.
• People who test positive for hepatitis B surface antigen or have detectable hepatitis B virus in their blood.
• People who test positive for both hepatitis C antibodies and hepatitis C virus in their blood.
• People who have HIV, have cytomegalovirus (CMV) levels above 400 copies/mL in their blood, or have a positive syphilis test result.
• People who have other immune system deficiency conditions.
• People with severe heart failure (Grade III or IV on a standard medical scale).
• People who have had another type of cancer in the past, unless it was a non-melanoma skin cancer or an in-situ cancer that was fully treated and cured, or another cancer that has shown no signs of returning for more than 5 years.
• People who have had a solid organ transplant (such as a kidney or liver transplant).
• People with a history of autoimmune diseases primarily involving abnormal immune cell activity, or who require ongoing immunosuppressive medication.
• People who have taken an experimental drug as part of another clinical trial within 3 months before signing the consent form.
• People who are pregnant or breastfeeding.
• People with psychiatric conditions, altered consciousness, or certain diseases of the nervous system.
• People whose side effects from previous treatments have not settled back to a mild or baseline level (with the exception of hair loss).
• People who have taken high-dose steroid medications within 72 hours before the CAR-T cell treatment is given (low-dose replacement steroids may be permitted — confirm with trial site).
• People who have not stopped certain cancer-treating medications for the required time before a blood cell collection procedure (the exact timeframes vary by drug type — confirm with trial site).
• People who have an active lung infection.
• People who have a medical reason why blood cannot be collected from their veins using an apheresis procedure.
• People whom the trial doctors consider unsuitable for other medical reasons.

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