TBI-2001 for Relapsed or Refractory B-cell Lymphoma

Study of TBI-2001(Autologous CD19 Specific Chimeric Antigen Receptor (CAR) Gene-transduced T Lymphocytes) for Relapsed or Refractory CD19+ B-cell Lymphoma, CLL/SLL

Recruiting Phase 1 Interventional Study
Relapsed or Refractory CD19+ B-cell Lymphoma Relapsed or Refractory Chronic Lymphocytic Leukemia Relapsed or Refractory Small Lymphocytic Lymphoma
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
19 (estimated)
Sponsor
University Health Network, Toronto · Other
Who this trial is looking for

This trial is looking for adults with certain types of B-cell cancers that have not responded to previous treatments. Participants will receive a special type of immune cell therapy called TBI-2001.

Are You a Good Fit for This Trial?
Rules you out HIV positivityActive hepatitis BActive hepatitis C

You may be able to join if

  • I am at least 18 years old.
  • I have been diagnosed with CD19 positive B-cell lymphoma or CLL/SLL.
  • I have received at least 2 prior cancer treatments.
  • My cancer is considered incurable and can receive TBI-2001 within 3 months.
  • My overall health is good enough to participate.
  • I expect to live more than 4 months.
  • I have given informed consent according to the rules.

You may not be able to join if

  • I have uncontrolled medical conditions that could interfere.
  • I have active or recent autoimmune disease within the last 2 years.
  • I have a history of primary immunodeficiency.
  • I have had an organ transplant and take immunosuppressive medications.
  • I have untreated CNS metastases requiring more treatment.
  • I have been diagnosed with untreated active tuberculosis.
  • I am pregnant or breastfeeding.
  • I have had any prior treatment specifically targeting CD19.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

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About This Trial

This is a Phase 1/1b, open-label, dose-escalation study to evaluate the safety and the efficacy of anti-CD19 chimeric antigen receptor (CAR) (TBI-2001) for relapsed or refractory CD19+ B-cell lymphoma Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Patients with histologically or cytologically confirmed CD19 positive B cell Non-Hodgkin Lymphoma (NHL), Chronic Lymphocytic Leukemia (CLL), or Small Lymphocytic Lymphoma (SLL) who have received at least 2 prior therapies. 2. Phase Ib cohort will enroll CLL/SLL patients only.…
Contacts

Marcus Butler, M.D.

416-946-4501

tip@uhn.ca

CONTACT