FDA Grants Fast Track Designation to Adicet Bio’s CAR T-cell Therapy for Systemic Lupus Erythematosus

Credit: MP Studio | stock.adobe.com

The FDA has awarded Fast Track Designation (FTD) Adicet Bio, Inc’s novel allogeneic gamma delta chimeric antigen receptor (CAR) T-cell therapy ADI-001 for adults with refractory systemic lupus erythematosus (SLE) with extrarenal involvement.¹ The regulatory action marks the second such designation for ADI-001, after it was granted FTD in June 2024 for the treatment of relapsed/refractory class III or class IV lupus nephritis (LN).²

“The FDA’s decision to grant ADI-001 Fast Track Designation for lupus nephritis underscores the urgent need for new therapies for this chronic disease,” Chen Schor, president and chief executive officer of Adicet Bio, said in a prior press release regarding the designation for LN. “We plan to initiate our Phase 1 clinical study in lupus nephritis later this month. With clinical data for ADI-001 in non-Hodgkin’s lymphoma demonstrating CD19+ B-cell depletion that mirrors data by autologous alpha-beta CAR T in academic clinical studies in several autoimmune diseases, we believe we are well positioned to expand our autoimmune program to address additional indications beyond lupus nephritis. We look forward to providing a comprehensive update on our autoimmune program to investors in the near term.”²

Adicet Bio, Inc. is currently testing the investigational ADI-001 across six autoimmune indications. In addition to SLE, patient enrollment is ongoing for a Phase I trial of the drug for the treatment of LN, systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS). Adicet Bio stated that it expects to initiate the trial in the first quarter of 2025. The company projects enrollment initiation to begin for a trial of ADI-001 in anti-neutrophil cytoplasmic autoantibody-associated vasculitis in the second half of 2025.

The trial has four separate cohorts, with LN and SLE patients in a cohort, SSc patients in a cohort, IIM and SPS patients in a cohort, and AAV patients in a fourth cohort. Investigators will administer a single dose of ADI-001 to these patient populations. A dose-limiting toxicity window will last for 28 days, at which point investigators will assess response and safety, as well as during a follow up period on months three, six, nine, 12, 18, and 24.

The primary endpoints of the trial are assessments of the safety and tolerability of ADI-001, with secondary endpoints that include measurement of cellular kinetics; pharmacodynamics; autoantibody titer changes; and appropriate disease activity scores for each of the conditions.

During the Phase I GLEAN trial, investigators found that ADI-001 targets B-cells via an anti-CD20 CAR, showing robust exposure and complete CD19+ B-cell depletion in peripheral blood and in secondary lymphoid tissue.³

“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,” Francesco Galimi, MD, PhD, senior vice president and chief medical officer of Adicet Bio, said in a press release at the time the first patient was dosed in the trial. “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.”³

Galimi added that the company anticipates providing preliminary clinical data from the trial during the first half of 2025.

References

1. Adicet Bio. Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement. February 5, 2025. Accessed February 5, 2025. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-receives-fda-fast-track-designation-adi-001-treatment

2. Adicet Bio. Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis. June 5, 2024. Accessed February 5, 2025. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-receives-fda-fast-track-designation-adi-001-lupus

3. Adicet Bio. Adicet Bio Announces First Lupus Nephritis Patient Dosed in Phase 1 Clinical Trial of ADI-001 in Autoimmune Diseases. November 18, 2024. Accessed February 5, 2025. https://investor.adicetbio.com/news-releases/news-release-details/adicet-bio-announces-first-lupus-nephritis-patient-dosed-phase-1