Phase 1 Lymphoma Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who have been diagnosed with CD19-positive B cell Non-Hodgkin Lymphoma (a type of blood cancer), Chronic Lymphocytic Leukemia, or Small Lymphocytic Lymphoma, confirmed by laboratory testing, and who have already received at least 2 previous treatments.
- People enrolling in the Phase Ib part of the trial must have Chronic Lymphocytic Leukemia or Small Lymphocytic Lymphoma specifically.
- People who are reasonably active and able to care for themselves (rated 0 or 1 on a standard medical activity scale).
- People aged 18 or older at the time of signing consent.
- People whose doctors estimate they have a life expectancy of more than 4 months.
- People whose heart, lungs, liver, kidneys, bone marrow, and other key organs are functioning well enough to meet the trial's health requirements.
- People whose treating doctor considers their disease to be incurable and who may be a suitable candidate for the trial treatment within the next 3 months.
- People who are able to give proper informed consent in line with local and regulatory requirements.
Who may not be able to join:
- People with serious ongoing illnesses or medical conditions that could interfere with taking part in the trial.
- People with an active autoimmune disease (where the immune system attacks the body), or who have had one within the past 2 years.
- People with a history of a condition where the immune system does not work properly from birth or early life (primary immunodeficiency).
- People who have had an organ transplant and need to take medications to prevent rejection.
- People with a known allergy or sensitivity to any ingredient in the trial drug.
- People who have cancer that has spread to the brain or spinal cord and has not yet been treated.
- People who have had another serious cancer within the past 2 years (some non-invasive cancers may be exceptions — confirm with trial site).
- People who have taken immune-suppressing medications within 14 days before the cell collection procedure (apheresis).
- People with untreated active tuberculosis.
- People who are HIV positive.
- People with an active HTLV (a virus affecting white blood cells) or active syphilis infection.
- People with active Hepatitis B or active Hepatitis C (people with a negative blood test showing no detectable virus may still be considered — confirm with trial site).
- People who are pregnant or breastfeeding.
- People who have previously received a bone marrow or stem cell transplant from another person (allogeneic transplant).
- People who have previously received any treatment that specifically targets CD19 (the same marker this trial targets).
- People who have received a live vaccine within 28 days before the cell collection procedure.
- People whose doctor believes, for any other reason, that participation would not be appropriate or safe.
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Marcus Butler, M.D., Princess Margaret Cancer Centre
Phone: 416-946-4501
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Safety of TBI-2001; Safety of TBI-2001; Safety of TBI-2001; Recommended phase 2 dose (RP2D) of TBI-2001
Can't join this trial?
Data last synced from ClinicalTrials.gov: 23 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.