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
Relapsed or Refractory CD19+ B-cell Lymphoma, Relapsed or Refractory Chronic Lymphocytic Leukemia, Relapsed or Refractory Small Lymphocytic Lymphoma
About this trial
This is an interventional treatment trial for Relapsed or Refractory CD19+ B-cell Lymphoma focused on measuring CD19+ B-cell Lymphoma, Chronic Lymphocytic Leukemia, CLL, Small Lymphocytic Lymphoma, SLL, Lymphoma, TBI-2001, Anti-CD19 CAR Expressing T cell Therapy, CD19 CAR Gene-Transduced Lymphocyte, Adoptive Immunotherapy, Genetically Engineered Lymphocyte Therapy, Retroviral Vector, Neoplasms by Histologic Type, Neoplasms, Neoplasms, Experimental, Immune System Diseases, Chimeric Antigen Receptor
Eligibility Criteria
Inclusion Criteria: 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. No anti-cancer chemotherapy, radiation therapy or immunotherapy within 2 weeks prior to apheresis for generation of TBI-2001. 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 Criteria: Uncontrolled intercurrent illnesses or medical conditions that may interfere with trial participation. Active or prior documented autoimmune disease within the past 2 years. History of primary immunodeficiency. History of organ transplant that requires use of immunosuppressive medications. 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. Other invasive malignancy within 2 years except for noninvasive malignancies Current or prior use of immunosuppressive medication within 14 days before apheresis. 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. Received allogeneic-HSCT. Any prior CD19 directed therapy.
Sites / Locations
- Princess Margaret Cancer CentreRecruiting
Arms of the Study
Arm 1
Experimental
Experimental: Dose Level 1 to 3
0.3 to 3 x 10^6 autologous CD19-CAR-T cells/kg per patient will be administered intravenously after a conditioning chemotherapy with cyclophosphamide and fludarabine.