Activated clinical sites for Phase 1 trial of ADI-001 in autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV)
Enrollment open for patients with LN; enrollment in SLE, SSC, and AAV expected to open in the fourth quarter of 2024
REDWOOD CITY, CA & BOSTON, MA, USA I September 30, 2024 I Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
“The favorable safety profile, cellular kinetics and B cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with ADI-001 clinical experience to date, positions ADI-001 to potentially bring a paradigm shift in the treatment of autoimmune diseases,” said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. “We expect to have several additional sites open for enrollment by the end of the fourth quarter of 2024, and further increase the number of active sites during the first quarter of 2025. At this time, our sites are open to enroll patients with LN, and we plan to initiate enrollment of patients with SLE, SSc, and AAV in the fourth quarter of this year. We look forward to reporting preliminary clinical data from this trial of ADI-001 in LN as well as SLE, SSc, and AAV in the first half of 2025.”
This announcement follows the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track Designation to ADI-001 for the treatment of relapsed/refractory class III or class IV LN and clearance from the FDA to develop ADI-001 in four autoimmune indications, including LN, SLE, SSc, and AAV.
The Phase 1 study has three separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm and AAV patients into a third arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication.
About ADI-001
ADI-001is aninvestigational allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV lupus nephritis and relapsed or refractory B-cell NHL.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
SOURCE: Adicet Bio
Post Views: 136
Activated clinical sites for Phase 1 trial of ADI-001 in autoimmune diseases, including lupus nephritis (LN), systemic lupus erythematosus (SLE), systemic sclerosis (SSc) and anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV)
Enrollment open for patients with LN; enrollment in SLE, SSC, and AAV expected to open in the fourth quarter of 2024
REDWOOD CITY, CA & BOSTON, MA, USA I September 30, 2024 I Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, today announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
“The favorable safety profile, cellular kinetics and B cell depletion in peripheral blood and secondary lymphoid tissue demonstrated with ADI-001 clinical experience to date, positions ADI-001 to potentially bring a paradigm shift in the treatment of autoimmune diseases,” said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. “We expect to have several additional sites open for enrollment by the end of the fourth quarter of 2024, and further increase the number of active sites during the first quarter of 2025. At this time, our sites are open to enroll patients with LN, and we plan to initiate enrollment of patients with SLE, SSc, and AAV in the fourth quarter of this year. We look forward to reporting preliminary clinical data from this trial of ADI-001 in LN as well as SLE, SSc, and AAV in the first half of 2025.”
This announcement follows the U.S. Food and Drug Administration’s (FDA) decision to grant Fast Track Designation to ADI-001 for the treatment of relapsed/refractory class III or class IV LN and clearance from the FDA to develop ADI-001 in four autoimmune indications, including LN, SLE, SSc, and AAV.
The Phase 1 study has three separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm and AAV patients into a third arm. Enrolled patients will receive a single dose of ADI-001. The dose-limiting toxicity window is 28 days with response and safety assessments conducted on Day 28 and during the follow up period on months 3, 6, 9, 12, 18 and 24. The primary objectives of the study are to evaluate the safety and tolerability of ADI-001. Secondary objectives include measuring cellular kinetics, pharmacodynamics, changes in autoantibody titers, and appropriate disease activity scores in each indication.
About ADI-001
ADI-001is aninvestigational allogeneic gamma delta CAR T cell therapy targeting B-cells via an anti-CD20 CAR. ADI-001 was granted Fast Track Designation by the FDA for the potential treatment of relapsed/refractory class III or class IV lupus nephritis and relapsed or refractory B-cell NHL.
About Adicet Bio, Inc.
Adicet Bio, Inc. is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients. For more information, please visit our website at https://www.adicetbio.com.
SOURCE: Adicet Bio
Post Views: 136
