CLIC-1901 / Ottawa Hospital Research Institute - LARVOL DELTA

MACROPHAGE ACTIVATION BEFORE LYMPHODEPLETION CAN PREDICT CRS, ICANS, AND LATE CYTOPENIA AFTER CD19 CAR-T CELL THERAPY FOR HEMATOLOGICAL CANCER (EBMT 2026) - "Patients received tisagenlecleucel (n=13), axicabtagene ciloleucel (n=10), or an academic CAR-T product (DK-CLIC-1901, n=12). Elevated levels of sMR and sCD163 before the start of lymphodepletion were associated with the development of severe CRS, ICANS, and late cytopenia in patients treated with CD19 CAR-T therapy, indicating a potential role as risk biomarkers. Our findings further support the emerging evidence of a role of activated macrophages in the pathogenesis of CAR-T-related toxicities and point to macrophage-targeted interventions as a possible therapeutic strategy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Inflammation • Neutropenia • Oncology • Thrombocytopenia • IL6

MACROPHAGE ACTIVATION BEFORE LYMPHODEPLETION CAN PREDICT CRS, ICANS, AND LATE CYTOPENIA AFTER CD19 CAR-T CELL THERAPY FOR HEMATOLOGICAL CANCER (EBMT 2026) - "Patients received tisagenlecleucel (n=13), axicabtagene ciloleucel (n=10), or an academic CAR-T product (DK-CLIC-1901, n=12). Elevated levels of sMR and sCD163 before the start of lymphodepletion were associated with the development of severe CRS, ICANS, and late cytopenia in patients treated with CD19 CAR-T therapy, indicating a potential role as risk biomarkers. Our findings further support the emerging evidence of a role of activated macrophages in the pathogenesis of CAR-T-related toxicities and point to macrophage-targeted interventions as a possible therapeutic strategy."

CAR T-Cell Therapy • IO biomarker • Hematological Malignancies • Inflammation • Neutropenia • Oncology • Thrombocytopenia • IL6

DAN-CART 1901: PRELIMINARY RESULTS OF SAFE AND FEASIBLE ADMINISTRATION OF THE FRESH AUTOLOGOUS ANTI-CD19 CAR-T PRODUCT DK-CLIC-1901 (EBMT 2026) - "This is the first trial of point-of-care manufactured CAR-T cells in Denmark and demonstrates that administering fresh CLIC-1901 product is safe, feasible and efficacious, especially in patients with low tumor burden. Our platform provides a feasible and rapid manufacturing procedure for future CAR-T products, which may also include targets outside commercial interests."

CAR T-Cell Therapy • Bone Marrow Transplantation • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Neutropenia • Thrombocytopenia

DAN-CART 1901: PRELIMINARY RESULTS OF SAFE AND FEASIBLE ADMINISTRATION OF THE FRESH AUTOLOGOUS ANTI-CD19 CAR-T PRODUCT DK-CLIC-1901 (EBMT 2026) - "This is the first trial of point-of-care manufactured CAR-T cells in Denmark and demonstrates that administering fresh CLIC-1901 product is safe, feasible and efficacious, especially in patients with low tumor burden. Our platform provides a feasible and rapid manufacturing procedure for future CAR-T products, which may also include targets outside commercial interests."

CAR T-Cell Therapy • Bone Marrow Transplantation • Cerebral Hemorrhage • CNS Disorders • Hematological Malignancies • Neutropenia • Thrombocytopenia

CLIC-01: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Ottawa Hospital Research Institute | Trial completion date: Oct 2037 ➔ Jun 2042 | Trial primary completion date: Oct 2024 ➔ Jan 2027

Trial completion date • Trial primary completion date • Acute Lymphocytic Leukemia • B Cell Lymphoma • B Cell Non-Hodgkin Lymphoma • Chronic Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Primary Mediastinal Large B-Cell Lymphoma • CD19

CLIC-01: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies (clinicaltrials.gov) - P1/2 | N=60 | Recruiting | Sponsor: Ottawa Hospital Research Institute | Trial completion date: Oct 2022 ➔ Oct 2037 | Trial primary completion date: Oct 2022 ➔ Oct 2024

Trial completion date • Trial primary completion date • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Oncology • CD19

CLIC-01: Manufacture and distribution of non-cryopreserved CAR-T cells for patients with CD19 positive hematologic malignancies. (PubMed, Front Immunol) - P1/2 | "We report initial results from a single-arm, open-label study to determine the safety and efficacy of in-house manufactured CD19 CAR-T cells (entitled CLIC-1901) in participants with relapsed/refractory CD19 positive hematologic malignancies...Participants underwent lymphodepletion with fludarabine and cyclophosphamide, followed by infusion of non-cryopreserved CAR-T cells...Our experience may provide helpful guidance for other jurisdictions seeking to create feasible and sustainable CAR-T cell programs in research-oriented yet resource-constrained settings. https://clinicaltrials.gov/ct2/show/NCT03765177, identifier NCT03765177."

CAR T-Cell Therapy • Journal • Acute Lymphocytic Leukemia • Hematological Disorders • Hematological Malignancies • Inflammation • Leukemia • Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

Study of genetically modified patient immune cells in treatment of refractory leukemia and lymphoma of B-cell origin CLIC-1901 CAR T-celler som behandling af patienter recidiveret/behandlingsresistent CD19-positiv ALL og NHL (DAN-CART 1901) (clinicaltrialsregister.eu) - P2 | N=20 | Sponsor: Rigshospitalet

CAR T-Cell Therapy • New P2 trial • Acute Lymphocytic Leukemia • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • CD19

[VIRTUAL] Perfusion enables increased lentivirus production using the iCELLis® bioreactor system (ACS-Fall 2020) - "The Ottawa Hospital recently developed a lentivirus manufacturing process using adherent cells in a flatware culture system, and used this process to produce sufficient amounts of clinical-grade lentivirus in a GMP manner for a Canadian CLIC-1901 CD19-CAR T Phase I/II clinical trial...We hypothesized that this low titer was due to product instability in the bioreactor for long exposure times, and therefore implement a perfusion-based feeding system to remove product from the bioreactor for storage at more stable conditions. In this poster, we demonstrate that this perfusion strategy successfully resulted in bioreactor titers greater than the legacy flatware process for n=4 batches."

Gene Therapies • CD19

CLIC-01: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=60; Recruiting; Sponsor: Ottawa Hospital Research Institute; Not yet recruiting ➔ Recruiting; Trial primary completion date: Oct 2020 ➔ Oct 2022

Clinical • Enrollment open • Trial primary completion date

CLIC-01: CLIC-1901 for the Treatment of Patients With Relapsed/Refractory CD19 Positive Hematologic Malignancies (clinicaltrials.gov) - P1/2; N=60; Not yet recruiting; Sponsor: Ottawa Hospital Research Institute; Trial completion date: Mar 2022 ➔ Oct 2022; Initiation date: Mar 2019 ➔ Oct 2019; Trial primary completion date: Mar 2020 ➔ Oct 2020

Clinical • Trial completion date • Trial initiation date • Trial primary completion date