Adicet Bio, Inc, a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer, announced that the first LN patient has been dosed in the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
“Dosing the first lupus nephritis patient in our Phase 1 trial of ADI-001 marks an important step forward in our mission of improving the lives of patients affected by autoimmune diseases, particularly lupus nephritis,” said Francesco Galimi, M.D., Ph.D., Senior Vice President and Chief Medical Officer of Adicet Bio. “With clinical biomarker data from our study in non-Hodgkin’s lymphoma demonstrating robust tissue trafficking and complete CD19+ B cell depletion in peripheral blood and secondary lymphoid tissue, ADI-001 has the potential to be a transformative off-the-shelf treatment option for several autoimmune diseases. Additionally, the FDA’s Fast Track Designation to ADI-001 in relapsed/refractory class III or class IV LN and the clearance of our investigational IND amendment application of ADI-001 for the treatment of SPS and IIM further serves to emphasize the broad and urgent unmet need for approved therapies to address autoimmune diseases.”
Dr. Galimi continued, “With clinical sites open for enrollment and additional sites that are expected to open in the near future, we anticipate sharing preliminary clinical data from the trial in the first half of 2025. In addition, we look forward to initiating enrollment for SLE, SSc, IIM, and SPS patients in the first quarter of 2025 and for AAV patients in the second half of 2025.”
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About ADI-001
ADI-001 is an investigational 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.
About the Phase 1 Trial
The Phase 1 study has four separate arms, enrolling LN and SLE patients into one arm, SSc patients into a second arm, IIM and SPS patients in a third arm and AAV patients into a fourth 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.
SOURCE: Businesswire