CLBR001/SWI019 / Scripps Research Institute, AbbVie - LARVOL DELTA

Calibr-Skaggs receives FDA approval to test sCAR-T therapy in patients with autoimmune diseases (News-Medical) - "Calibr-Skaggs Institute for Innovative Medicines...announced today that the FDA has cleared their investigational new drug (IND) application to study switchable chimeric antigen receptor T cell (sCAR-T) therapy (CLBR001 + SWI019) in patients with autoimmune conditions. Patient recruitment for the phase 1 trial will begin soon (NCT06913608). The phase 1 clinical trial will evaluate the safety and efficacy of CLBR001 + SWI019 in patients with myositis, systemic sclerosis, lupus and rheumatoid arthritis, with the potential to expand to other indications in the future."

IND • Trial status • Lupus • Myositis • Rheumatoid Arthritis • Systemic Sclerosis

A Study to Assess CLBR001+SWI019 in Subjects With Autoimmune Diseases (clinicaltrials.gov) - P1 | N=12 | Not yet recruiting | Sponsor: Calibr, a division of Scripps Research

New P1 trial • Immunology • Inflammatory Arthritis • Lupus • Myositis • Scleroderma • Systemic Lupus Erythematosus • Systemic Sclerosis

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=18 | Completed | Sponsor: Calibr, a division of Scripps Research | Active, not recruiting ➔ Completed

Trial completion • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=18 | Active, not recruiting | Sponsor: Calibr, a division of Scripps Research | N=36 ➔ 18 | Trial primary completion date: Aug 2023 ➔ Apr 2024

Enrollment change • Trial primary completion date • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies (clinicaltrials.gov) - P1 | N=36 | Active, not recruiting | Sponsor: Calibr, a division of Scripps Research | Recruiting ➔ Active, not recruiting

Enrollment closed • Burkitt Lymphoma • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Lymphoplasmacytic Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • Waldenstrom Macroglobulinemia • IL2 • IL6 • TNFA

IND-Enabling Studies of a Switchable Chimeric Antigen Receptor-T Cell (CLBR001+SWI019) to Support First in Human Clinical Study (ASH 2021) - P1 | "We expect this approach provides an excellent starting point for the first in human study which balances safety and the potential for patient benefit. In summary, the results presented in this abstract led to the initiation of clinical trial NCT04450069, the combination of CLBR001+SWI019 for the treatment of relapse/ refractory B cell malignancies."

CAR T-Cell Therapy • Clinical • IO biomarker • P1 data • Oncology • CD19 • IFNG • IL2 • TNFA

First in Human Study of an on/Off Switchable CAR-T Cell Platform Targeting CD19 for B Cell Malignancies (CLBR001 + SWI019) (ASH 2021) - P1 | "Following cyclophosphamide and fludarabine lymphodepletion, patients receive a single dose of CLBR001 cells, followed by daily infusion of SWI019 for 7 days...This event subsided within 24 hours of administration of dexamethasone with no recurrence of CRS observed with continued administration of a reduced dose (50%) of SWI109, providing support for the tunability of the platform...Accrual is ongoing in dose expansion cohorts of both CLBR001 cells and SWI019 switch. Updated results will be presented at the meeting."

CAR T-Cell Therapy • P1 data • Follicular Lymphoma • Hematological Malignancies • Inflammation • Lymphoma • Mantle Cell Lymphoma • Oncology • CD19

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Calibr, a division of Scripps Research; Not yet recruiting ➔ Recruiting

Clinical • Enrollment open • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma • CD19

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T (clinicaltrials.gov) - P1; N=36; Enrolling by invitation; Sponsor: Calibr, a division of Scripps Research; Recruiting ➔ Enrolling by invitation

Clinical • Enrollment status • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

[VIRTUAL] CLBR001+SWI019: A novel switchable CAR-T cell platform enabling functionally reversible on/off control of CAR-T cell activity for B cell malignancies (AACR 2021) - "A Phase 1 trial was initiated in mid-2020 for patients with relapsed, refractory B cell malignancies. We believe this approach has the potential to be applied to solid tumors in the future leveraging these “universal” CLBR001 CAR-T cells."

CAR T-Cell Therapy • Hematological Malignancies • Leukemia • Oncology • Solid Tumor • CD19

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T (clinicaltrials.gov) - P1; N=36; Recruiting; Sponsor: Calibr, a division of Scripps Research; Not yet recruiting ➔ Recruiting; Trial completion date: Aug 2038 ➔ Aug 2036; Initiation date: Oct 2020 ➔ Jan 2021; Trial primary completion date: Aug 2038 ➔ Aug 2036

Clinical • Enrollment open • Trial completion date • Trial initiation date • Trial primary completion date • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

FDA Grants Fast Track Designation to Novel CAR T-Cell Therapy for B-Cell Malignancies (Cancer Network) - "The FDA has granted fast track designation to the novel 'switchable' CAR-T cell therapy known as CLBR001 + SWI019, according to Calibr, the developer of the therapy....The therapy is currently being evaluated as a treatment for B-cell malignancies. A phase 1 clinical trial of CLBR001 + SWI019 (NCT04450069) has begun enrolling subjects at multiple sites in the US to assess the safety and tolerability of the cell therapy."

Enrollment open • Fast track designation • Diffuse Large B Cell Lymphoma • Hematological Malignancies • Non-Hodgkin’s Lymphoma • Oncology

Long-term Follow-up Study for Patients Treated With CLBR001 CAR-T (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Calibr, a division of Scripps Research

Clinical • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma

CLBR001 and SWI019 in Patients With Relapsed / Refractory B-cell Malignancies (clinicaltrials.gov) - P1; N=36; Not yet recruiting; Sponsor: Calibr, a division of Scripps Research

Clinical • New P1 trial • Chronic Lymphocytic Leukemia • Diffuse Large B Cell Lymphoma • Follicular Lymphoma • Hematological Disorders • Hematological Malignancies • Leukemia • Lymphoma • Mantle Cell Lymphoma • Marginal Zone Lymphoma • Non-Hodgkin’s Lymphoma • Oncology • Small Lymphocytic Lymphoma