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 signed and dated a consent form and are willing and available to follow all study requirements for the full duration of the trial.
• People aged 18 or older, of any gender.
• For the dose-escalation (early) phase: People with a type of blood cancer called CD20-positive non-Hodgkin lymphoma (confirmed at first diagnosis, and still testing positive for CD20), whose cancer has come back or stopped responding to treatment after at least 2 previous treatment courses, and for whom no suitable treatment options remain.
• For the dose-expansion phase – Group 1: People with a confirmed diagnosis of CD20-positive diffuse large B-cell lymphoma (DLBCL) or a related aggressive B-cell lymphoma type (including certain subtypes such as DLBCL-NOS, high-grade B-cell lymphoma, primary mediastinal large B-cell lymphoma, transformed follicular lymphoma, or follicular lymphoma grade 3b), whose cancer has not responded to or has returned after at least two rounds of treatment — with at least one of those rounds including anti-CD20 therapy and at least one including a chemotherapy type called anthracyclines.
• For the dose-expansion phase – Group 2: People with a confirmed diagnosis of CD20-positive follicular lymphoma (FL) of grades 1 to 3a, whose cancer has not responded to or has come back after at least two rounds of treatment (including at least one anti-CD20 therapy and one alkylating agent chemotherapy), and whose cancer is causing symptoms or is large enough to require treatment.
• For the dose-expansion phase – Group 3: People with a confirmed diagnosis of a CD20-positive non-Hodgkin lymphoma type not covered in Groups 1 or 2, whose cancer has not responded to or returned after at least two rounds of standard treatment including a combination of anti-CD20 antibody and chemotherapy — and, for slower-growing lymphomas, whose cancer is causing symptoms or is large enough to require treatment.
• People who have at least one area of cancer that can be measured in two directions on a CT or MRI scan (a lymph node lesion at least 1.5 cm, or a lesion outside lymph nodes at least 1.0 cm).
• People with a general health/activity level score of 0 to 2 on the ECOG scale (able to carry out some or all normal daily activities, confirm with trial site).
• People with a life expectancy of at least 12 weeks.
• People whose blood test results meet minimum levels for blood cell counts, liver function, kidney function, and blood clotting, as assessed before each treatment cycle (confirm specific values with trial site).
• People of childbearing potential who agree to use highly effective contraception during treatment and for 90 days after the last dose; women of childbearing potential must have a negative pregnancy blood test within 7 days before joining and must not be breastfeeding.

Who may not be able to join:

• People with a known history of serious allergic reactions to medications, biological products, foreign proteins, or ingredients in the study drug.
• People with an active infection that is not under control at the time of screening.
• People who have previously had an organ transplant or a bone marrow/stem cell transplant from a donor, or who have had their own stem cells transplanted or received CAR-T cell therapy within the past 3 months.
• People who have had cancer spread to the brain or spinal cord, or who have had a serious brain condition (such as epilepsy, stroke, or brain bleed) within the past 6 months, or who have a history of a nerve or movement disorder — or who have had a seizure within the past 12 months.
• People with a known active HIV, hepatitis B, or hepatitis C infection (certain controlled or resolved cases may still be eligible — confirm with trial site).
• People who still have side effects from previous cancer treatment that have not improved to a mild level (grade 1 or lower), except for hair loss or other effects the doctor considers acceptable.
• People who have been diagnosed with another cancer in the past 5 years, except for certain fully treated skin cancers or cervical cancer in its earliest stage.
• People who have received any vaccine within 4 weeks before the start of pre-treatment, or who plan to receive a vaccine during the study.
• People who have used systemic immune-suppressing medications — including certain antibody therapies, immune or cytokine treatments, or monoclonal antibodies — within 4 weeks before the start of pre-treatment.
• People with a history of active autoimmune diseases such as lupus, rheumatoid arthritis, multiple sclerosis, inflammatory bowel disease, autoimmune hepatitis, myasthenia gravis, vasculitis, or similar conditions.
• People whom the treating doctor considers unsuitable for the trial for any other reason.

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