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 to take part voluntarily and sign a consent form
• Adults aged 18 to 75 years (any gender)
• During the dose-finding stage: people with a type of mature B-cell blood cancer confirmed by tissue testing (using 2017 WHO standards) whose previous treatments have not worked and who have no other suitable treatment options
• During the dose-expansion stage: people with B-cell lymphoma confirmed by tissue testing (including a group for DLBCL and a group for other B-cell lymphomas), or people with certain bone marrow/blood cancers including AML or MDS confirmed by 2016 WHO standards
• People with slower-growing B-cell lymphomas (such as follicular lymphoma, marginal zone lymphoma, or Waldenström macroglobulinemia) who have received at least two prior treatment courses, including at least one that contained an anti-CD20 antibody drug
• People with CLL or SLL who have received at least two prior treatment courses, including treatment with a BTK inhibitor or BCL-2 inhibitor
• People with mantle cell lymphoma (MCL) who have received at least two prior treatment courses (including anti-CD20 antibodies and BTK inhibitors)
• People with aggressive B-cell lymphoma (DLBCL) whose disease has not responded to or has come back after at least two prior treatment courses, and who are not suitable for a stem cell transplant
• People with AML that has come back or stopped responding to treatment, as defined by Chinese treatment guidelines (2021 edition)
• People with MDS confirmed by tissue testing, assessed as intermediate-to-high risk by a standard scoring system (IPSS-R score above 3), that has come back or stopped responding to treatment
• People with B-cell lymphoma who have at least one measurable area of disease visible on imaging (lymph node longer than 1.5 cm, or a lesion outside lymph nodes longer than 1.0 cm)
• People who are willing to have a bone marrow sample taken (aspiration and/or biopsy)
• People with a general health/activity score (ECOG) of 0–1 during the dose-finding stage, or 0–2 during the dose-expansion stage
• People with an expected survival of at least 3 months
• People whose bone marrow blood counts meet minimum levels without needing growth factor support (specific thresholds for white blood cells, platelets, and haemoglobin apply — confirm with trial site)
• People whose liver function, kidney function, and blood-clotting test results are within acceptable ranges in the week before the first dose (confirm specific values with trial site)
• Women who could become pregnant must have a negative pregnancy blood test within 7 days before the first dose, and must agree to use reliable contraception from signing the consent form until 3 months after the last dose
• People who are able to follow the study schedule and attend all required visits

Who may not be able to join:

• People with Burkitt lymphoma/leukemia, plasma cell myeloma, or plasmablastic lymphoma
• People with a specific type of leukaemia called acute promyelocytic leukemia (APL), AML with a BCR-ABL gene abnormality, or a history of myeloproliferative neoplasms
• People who have taken other cancer-fighting or experimental drugs within 14 days (or 5 half-lives, whichever is shorter) before the first dose, or cancer immunotherapy or antibody treatments within 4 weeks before the first dose (with some exceptions — confirm with trial site)
• People who have had major surgery within 4 weeks before the first dose, or who are expected to need major surgery during the trial
• People who have had full-body radiation therapy within 4 weeks before the first dose
• People who still have significant side effects from previous cancer treatments (above a mild level), unless those effects are considered stable and not a safety concern
• People who have previously had an allogeneic (donor) stem cell transplant; or an autologous (own cells) stem cell transplant or immune cell therapy within 3 months before the first dose (for B-cell cancers) or within 6 months (for AML or MDS)
• People whose lymphoma or leukaemia has spread to the brain or spinal cord (central nervous system)
• People who have difficulty swallowing, or a history of serious gut conditions (such as active inflammatory bowel disease, bowel perforation, Crohn's disease, ulcerative colitis, bowel obstruction, or short bowel syndrome), or other conditions that affect how the body absorbs medication
• People with active eye conditions affecting the surface of the eye (conjunctiva or cornea), unless those conditions have been fully treated and resolved
• People with active or unstable heart or blood vessel conditions, including serious heart rhythm problems, recent heart attack, heart failure, stroke, blood clots, or uncontrolled high blood pressure (systolic 160 mmHg or above, or diastolic 100 mmHg or above despite medication)
• People with a heart pumping efficiency (LVEF) below 50%, certain inherited heart rhythm conditions, or a prolonged QT interval on a heart tracing (above 450 ms for men, above 470 ms for women)
• People with a history of scarring or inflammation of the lungs (interstitial lung disease or pulmonary fibrosis), or signs of active pneumonia on a chest scan during screening
• People with a congenital immune deficiency, or active autoimmune diseases (such as autoimmune anaemia or immune-related low platelet counts) that have been ongoing for 2 weeks or more and are not controlled
• People with bleeding disorders (such as haemophilia)
• People currently taking blood-thinning (anticoagulant) medications
• People with a history of severe allergies, or known allergy to any ingredient in the study drug
• People with an uncontrolled active infection (viral, bacterial, or fungal) within 2 weeks before the first dose; or active hepatitis B (with viral levels above 1000 IU/ml); or positive test results for hepatitis C or HIV
• People with another active primary cancer (though people with fully treated and removed skin cancers or completely removed carcinoma in situ may still be considered — confirm with trial site)
• People who need to continue taking systemic immune-suppressing drugs or corticosteroids (at a dose equivalent to 10 mg or more of prednisone per day) within 2 weeks before the trial drug starts
• People who have used certain strong medications that affect how the body processes drugs (strong CYP3A inhibitors or inducers) within 2 weeks before the first dose
• Women who are pregnant or breastfeeding
• People with any other serious or uncontrolled condition that the trial team considers would make participation unsafe or unsuitable

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