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 to 65 years (male or female) who provide written consent before any study procedures begin.
• People who are generally well enough to carry out light activity or desk work, based on a standard health performance scale (ECOG score of 0 or 1).
• People whose doctors estimate they are likely to live for more than 12 weeks.
• People diagnosed with a type of B-cell non-Hodgkin lymphoma (B-NHL) that has come back or stopped responding to treatment, specifically one of these subtypes: follicular lymphoma, MALT lymphoma, lymphoplasmacytic lymphoma, mantle cell lymphoma, small lymphocytic lymphoma, diffuse large B-cell lymphoma, primary mediastinal large B-cell lymphoma, grey zone lymphoma, or Burkitt lymphoma.
• People who have previously been treated with a drug called rituximab (unless they could not tolerate it) and have received at least two lines of prior treatment.
• People who have at least one measurable tumour that meets specific size requirements on a CT scan (confirm with trial site for exact measurements).
• People whose side effects from past treatments have largely resolved before the screening visit (except for hair loss).
• People with blood, liver, and kidney function within essentially normal ranges.
• Women who could become pregnant must have a negative blood pregnancy test and agree to use reliable contraception throughout the study and for 3 months after the last dose.
• Men must agree to use reliable contraception and avoid donating sperm throughout the study and for 90 days after the last dose.

Who may not be able to join:

• People who have received certain recent cancer treatments before the first study dose, including: biological or immunotherapy within 4 weeks, chemotherapy within 4 weeks, small molecule targeted drugs within 2 weeks or 5 half-lives (whichever is longer), other experimental drugs within 4 weeks or 5 half-lives (whichever is shorter), major radiotherapy within 4 weeks or local palliative radiotherapy within 2 weeks, or whose radiotherapy side effects have not yet resolved.
• People who received a stem cell transplant using their own cells (autologous HSCT) within 12 weeks before the first dose.
• People who have ever received a stem cell transplant using someone else's cells (allogeneic HSCT) or an organ transplant.
• People who have ever received CAR-T cell therapy.
• People who have had another type of cancer in the past 5 years, except for certain localised cancers that were fully treated and have shown no signs of return for at least 5 consecutive years.
• People whose lymphoma has spread to the brain or the lining of the brain in a way that is causing symptoms or is not under control.
• People with a history of, or current, significant brain or nervous system conditions such as epilepsy, seizures, paralysis, severe brain injury, psychosis, or inflammation of brain tissue visible on an MRI.
• People with a history or current signs of serious heart problems, including: recent heart attack, coronary stent or procedure within 6 months, uncontrolled irregular heart rhythms, severe heart rhythm problems, moderate-to-severe heart failure, significant heart valve abnormalities, reduced heart pumping function below set thresholds, certain abnormal heart electrical readings (QTcF levels above specified limits), an implanted defibrillator, or blood pressure that cannot be controlled with treatment.
• People with a known allergy to monoclonal antibody drugs or immunoglobulin products.
• People who have had major surgery or a significant injury within 4 weeks before the first dose, or who need planned surgery during the study, and whose related side effects have not yet resolved.
• People who have been taking regular systemic steroid medications (such as prednisone above a certain dose) in the 4 weeks before the study, or who are expected to need high-dose steroids during the trial, or who have taken other immune-suppressing medications within 4 weeks before joining.
• People whose virus blood test results are considered clinically significant by the study doctor (confirm with trial site for specific viruses).
• People with active infections that currently need systemic (whole-body) antibiotic, antiviral, or antifungal treatment.
• People with uncontrolled fluid build-up in body cavities such as around the lungs, abdomen, or heart.
• People who are pregnant or breastfeeding.
• People with mental health conditions or who are unlikely to be able to follow the study requirements.
• People who have received a live attenuated vaccine within 4 weeks before the first dose.
• People whom the study doctor considers unsuitable for any other reason.

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