Tests TBI-2001 cell therapy in adults with relapsed or refractory B-cell lymphoma or CLL

Trial details

Who runs it

University Health Network, Toronto

Trial code

NCT05963217

Record updated

9 June 2026

Original description

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).Read full original descriptionShow less

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 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).

Inclusion: 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; Phase Ib cohort will enroll CLL/SLL patients only; ECOG Performance Status 0 or 1; Age ≥18 years at time of consent; Life expectancy greater than 4 months; 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; Patients must have adequate key organ function (bone marrow, heart, lung, liver, renal, etc); Consent must be appropriately obtained in accordance with applicable local and regulatory requirements; 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: Active or prior documented autoimmune disease within the past 2 years; History hypersensitivity to components of manufacture or excipients of investigational drug; Untreated central nervous system (CNS) metastases requiring concurrent treatment, inclusive of but not limited to surgery, radiation, and/or corticosteroids; Current or prior use of immunosuppressive medication within 14 days before apheresis; Received allogeneic-HSCT; Any prior CD19 directed therapy; Live vaccine within 28 days prior to apheresis; Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation; History of primary immunodeficiency; History of organ transplant that requires use of immunosuppressive medications; Other invasive malignancy within 2 years except for noninvasive malignancies; 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; Known history of untreated active tuberculosis; HIV positivity; Active HTLV or syphilis infection; Active hepatitis B or active hepatitis C. Subjects with a negative PCR assay for viral load for hepatitis B or C are permitted; Pregnant or lactating women.

ClinicalTrials.gov NCT05963217