Adicet Bio Seeks to Join Clinical Trial Stage for Lupus Therapies


ADI-001 is also being evaluated in a phase 1 study in patients with B-cell non-Hodgkin lymphoma.

Adicet Bio has received Fast Track Designation for its allogeneic gamma delta T cell therapy ADI-001 for treating relapsed/refractory class III or class IV lupus nephritis, joining the race of clinical-stage candidates being developed for autoimmune diseases.1

“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, Adicet Bio, said in a statement.1 “We plan toinitiate 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 chimeric antigen receptor (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.”

Adicet originally developed ADI-001 for the treatment of relapsed or refractory aggressive B-cell non-Hodgkin lymphoma (NHL), for which it is being evaluated in a phase 1 study (NCT04735471). The company announced positive interim data from the study in June 2023, boasting an overall complete response (CR) rate of 63%, a 6-month CR rate of 25%, and a CR rate of 67% and 6-month CR rate of 33%in patients whose disease had progressed after CD19 CAR T-cell therapy.2

“We plan to transition the ADI-001 program into a potential pivotal Phase 2 study in post-CAR T LBCL in the first half of 2024. In addition, we expect to provide a clinical update which will include efficacy, 6-month CR rate, and safety data, from additional post-CAR T LBCL patients in the second half of 2024,” Francesco Galimi, MD, PhD, Senior Vice President and Chief Medical Officer of Adicet Bio, noted in a statement.2

READ MORE: World Lupus Day 2024: Looking Back at a Year of New Cell Therapy IND Clearances

In other recent news in the lupus space, Cabaletta Bio’s CABA-201, an investigational CD19-directed CAR T-cell therapy, recently demonstrated initial safety data in participants with systemic lupus erythematosus (SLE) and lupus nephritis in the phase 1/2 RESET-SLE clinical trial (NCT06121297). The first patients dosed have completed their 28-day dose-limiting toxicity observation window after receiving the CAR-T, with neither patient showing evidence of any grade cytokine release syndrome (CRS) or immune effector cell-associated neurotoxicity syndrome (ICANS).

“With no CRS or ICANS of any grade observed in either of the first patients from the RESET-Myositis and RESET-SLE trials, we look forward to presenting initial translational and clinical data from both patients during a satellite symposium at the EULAR 2024 Congress on June 14th,” Steven Nichtberger, MD, the chief executive officer and cofounder of Cabaletta, said in a statement.3

1. Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis. News release. Adicet Bio. June 5, 2024.
2. Adicet Bio Reports Positive Data from Ongoing ADI-001 Phase 1 Trial in Patients with Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL). News release. Adicet Bio. June 26, 2023.
3. Cabaletta Bio reports first quarter 2024 financial results and provides business update. News release. Cabaletta Bio, Inc. May 15, 2024.
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