TBI-2001 / Takara - LARVOL DELTA

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 (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: University Health Network, Toronto | Trial primary completion date: Mar 2025 ➔ Mar 2026

Trial primary completion date • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic 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 (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: University Health Network, Toronto | Trial completion date: Nov 2025 ➔ May 2026 | Trial primary completion date: Nov 2024 ➔ Mar 2025

Trial completion date • Trial primary completion date • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

Takara Bio Announces Presentation of Comparability Studies for CD19 JAK/STAT CAR-T Cell Technology Transfer (Takara Press Release) - "Takara Bio Inc...announced that Princess Margaret Cancer Centre (PM Cancer Centre) will present a poster at the Summit for Cancer Immunotherapy 2023 in Canada with regard to the studies performed at technology transfer of CD19 JAK/STAT CAR-T cell product (Development code: TBI-2001)...Its manufacturing process was developed by Takara Bio and transferred to the PM Cancer Centre in order to start a clinical trial in Canada. Comparability studies were performed to evaluate the products manufactured at the PM Cancer Centre and Takara Bio. Compatibility studies were also performed to determine the suitability of administration materials for the product infusion....A No Objection Letter has been received from Health Canada and the investigator-initiated clinical trial of TBI-2001 is underway. (ClinicalTrials.gov ID: NCT05963217)"

Canadian regulatory • Licensing / partnership • Preclinical • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic 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 (clinicaltrials.gov) - P1 | N=19 | Recruiting | Sponsor: University Health Network, Toronto

New P1 trial • Chronic Lymphocytic Leukemia • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

New CAR gene therapy TBI-2001 to begin investigator-initiated clinical trial in Canada [Google translation] - "On April 3, Takara Bio Inc. announced that it will start a physician-initiated clinical trial in Canada for a cancer treatment drug (development code: TBI-2001) using next-generation chimeric antigen receptor (CAR) gene therapy technology. . The drug is being jointly developed with Dr. Naoto Hirano, Chief of Immuno-Oncology Research Division at Princess Margaret Cancer Center....This time, we will evaluate the efficacy and safety of TBI-2001 in patients with CD19-positive B-cell lymphoma, chronic lymphocytic leukemia (CLL), and small lymphocytic lymphoma (SLL), and determine the recommended dose for phase 2 trials . A clinical trial for 19 patients will be enrolled."

Trial status • Chronic Lymphocytic Leukemia • Hematological Malignancies • Oncology • Small Lymphocytic Lymphoma