Phase 1 Lymphoma Trial, Recruiting NCT05963217 Sponsor: University Health Network, Toronto Condition: Lymphoma
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Phase 1 Lymphoma Trial, Recruiting

NCT05963217
Recruiting Phase 1

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.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 23 July 2026
Phase 1: approximately ~10% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

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

Status
Recruiting
Phase
Phase 1
Registry
ClinicalTrials.gov
Start date
26 July 2023
Est. completion
30 June 2028

Where this trial is recruiting

🇨🇦 Canada

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?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

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.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov