Treatment using engineered T cells for certain types of blood cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 1 clinical trial evaluates the safety and efficacy of TBI-2001, an autologous CD19-specific CAR T-cell therapy, for patients with relapsed or refractory CD19+ B-cell lymphoma, chronic lymphocytic leukemia (CLL), or small lymphocytic lymphoma (SLL). The study employs a dose-escalation design to determine the optimal dose of TBI-2001 following pre-treatment with cyclophosphamide and fludarabine. Participants will be monitored for safety and efficacy, with long-term follow-up extending up to five years post-infusion.

Why it matters

Who can join: the full rules

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.
3. ECOG Performance Status 0 or 1.
4. Age ≥18 years at time of consent.
5. Life expectancy greater than 4 months.
6. For cessation of therapies prior to apheresis and lymphodepleting chemotherapy (bridging therapies), the institutional (UHN) SOPs related to Kymriah will be followed. However, an exception will be made for targeted and biological therapies that decrease circulating disease and are not expected to negatively impact successful harvest of lymphocytes by apheresis. In these cases, after discussion with and approval by the Sponsor, no washout will be required.
7. Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc)
8. Consent must be appropriately obtained in accordance with applicable local and regulatory requirements.
9. The treating investigator should consider the patient to have disease that is incurable, and that the patient would be a reasonable candidate for future treatment with TBI-2001 within the next 3 months

Exclusion Criteria:

1. Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation.
2. Active or prior documented autoimmune disease within the past 2 years.
3. History of primary immunodeficiency.
4. History of organ transplant that requires use of immunosuppressive medications.
5. History hypersensitivity to components of manufacture or excipients of investigational drug.
6. Untreated central nervous system (CNS) metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids.
7. Other invasive malignancy within 2 years except for noninvasive malignancies
8. Current or prior use of immunosuppressive medication within 14 days before apheresis.
9. Any condition that, in the opinion of the investigator, would interfere with the evaluation of TBI-2001 or interpretation of subject safety or study results.
10. Known history of untreated active tuberculosis.
11. HIV positivity.
12. Active HTLV or syphilis infection.
13. Active hepatitis B or active hepatitis C. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted.
14. Pregnant or lactating women.
15. Received allogeneic-HSCT.
16. Any prior CD19 directed therapy.
17. Live vaccine within 28 days prior to apheresis.

Where it's running

• Princess Margaret Cancer Centre
  Toronto, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Marcus Butler, M.D. — Princess Margaret Cancer Centre
• Study coordinator: Marcus Butler, M.D.
• Email: tip@uhn.ca
• Phone: 416-946-4501

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.