Treatment using engineered T cells for certain types of blood cancer
Phase I/Ib Study of TBI-2001 for Patients With Relapsed or Refractory CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia (CLL), Small Lymphocytic Lymphoma (SLL)
This study is testing a new treatment using specially engineered T cells to see if it can help people with certain types of blood cancer that haven't responded to other treatments.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Enrollment | 19 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Health Network, Toronto Academic / other |
| Drugs / interventions | chemotherapy, radiation, chimeric antigen receptor, CAR-T, cyclophosphamide, fludarabine |
| Locations | 1 site (Toronto, Ontario) |
| Trial ID | NCT05963217 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with confirmed CD19+ B-cell malignancies who have undergone at least two prior therapies.
Not a fit: Patients with a poor performance status or those who have not received prior therapies may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients with difficult-to-treat blood cancers.
How similar studies have performed: Other studies using CAR T-cell therapies have shown promising results, indicating potential for success with this novel approach.
Eligibility criteria
Show full inclusion / exclusion 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. 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 this trial is running
Toronto, Ontario
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.