Drugs / ADI-001
ADI-001
Trials 3
| Phase | Registry id | Dates | Indication | Sponsor | Status | Outcome |
|---|---|---|---|---|---|---|
| Phase 1 | NCT07100873 | Oct 2025 → Mar 2027 expected | rheumatoid arthritis | Adicet Therapeutics | Recruiting | No outcome recorded |
| Phase 1 | NCT06375993 | Nov 2024 → Dec 2026 expected | anti-neutrophil cytoplasmic antibody-associated vasculitis, idiopathic inflammatory myopathy, lupus nephritis, stiff-person syndrome +2 | Adicet Therapeutics | Enrolling by invitation | No outcome recorded |
| Phase 1 | NCT04735471 | Mar 2021 → Feb 2025 | follicular lymphoma, mantle cell lymphoma, marginal zone lymphoma, primary mediastinal large B-cell lymphoma | Adicet Therapeutics | Terminated | No outcome recorded |
News releases announcing trial results or a regulatory action · 17
| Date | Issuer | Release |
|---|---|---|
| 2025-10-07 | Adicet Therapeutics | Results Adicet Bio Announces Positive Preliminary Data from ADI-001 Phase 1 Study in Patients with Lupus Nephritis (LN) and Systemic Lupus Erythematosus (SLE) adicetbio.com ↗
As of the August 31, 2025 data cut-off date, all five LN patients experienced improved renal function, including three complete renal responses and Definition Of Remission In Systemic lupus erythematosus (DORIS) remissions, and two partial renal responses, with all responses ongoing |
| 2025-02-27 | Adicet Therapeutics | Regulatory Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Systemic Sclerosis (SSc) adicetbio.com ↗
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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with systemic sclerosis (SSc). |
| 2025-02-05 | Adicet Therapeutics | Regulatory Adicet Bio Receives FDA Fast Track Designation for ADI-001 for the Treatment of Refractory Systemic Lupus Erythematosus (SLE) with Extrarenal Involvement adicetbio.com ↗
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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. |
| 2024-11-16 | Adicet Therapeutics | Results Adicet Bio Presents Clinical Biomarker Data for Off-the-Shelf CAR T Cell Therapy in an Oral Session at the American College of Rheumatology (ACR) Convergence 2024 adicetbio.com ↗
Data demonstrate characteristics essential for treatment of autoimmune diseases, including robust tissue homing and complete CD19+ B cell depletion in secondary lymphoid tissue |
| 2024-10-16 | Adicet Therapeutics | Regulatory Adicet Bio Announces FDA Clearance of IND Amendment to Evaluate ADI-001 in Idiopathic Inflammatory Myopathy and Stiff Person Syndrome adicetbio.com ↗ |
| 2024-09-19 | Adicet Therapeutics | Results ADI-001 Clinical Biomarker Data Demonstrate Robust Tissue Trafficking and Complete B Cell Depletion in Secondary Lymphoid Tissue adicetbio.com ↗
Notably, ADI-001 demonstrated robust tissue trafficking resulting in high levels of ADI-001, significant chimeric antigen receptor (CAR) T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue. |
| 2024-06-05 | Adicet Therapeutics | Regulatory Adicet Bio Receives FDA Fast Track Designation for ADI-001 in Lupus Nephritis adicetbio.com ↗
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 U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to ADI-001 for the potential treatment of relapsed/refractory class III or class IV lupus nephritis. |
| 2023-12-10 | Adicet Therapeutics | Results Adicet Bio Highlights ADI-001 Expansion, Persistence and Pharmacodynamic Profile from Ongoing Phase 1 Study at the 65th American Society of Hematology (ASH) Annual Meeting adicetbio.com ↗
ADI-001 showed robust dose-dependent expansion and persistence in patients with relapsed/refractory aggressive B-cell non-Hodgkin’s lymphoma (NHL) |
| 2023-06-26 | Adicet Therapeutics | Results 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) adicetbio.com ↗ |
| 2022-12-10 | Adicet Therapeutics | Results 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) adicetbio.com ↗ |
| 2022-11-03 | Adicet Therapeutics | Results Adicet Bio Reports ASH Abstract Data from Ongoing ADI-001 Phase 1 Trial in Relapsed or Refractory Aggressive B-Cell Non-Hodgkin’s Lymphoma (NHL) adicetbio.com ↗
As of the July 15, 2022 ASH abstract data-cut date, ADI-001 demonstrated a 78% overall and complete response rate and sustained durability in patients, including those previously exposed to CAR T therapy |
| 2022-06-06 | Adicet Therapeutics | Results Adicet Bio Reports Emerging Data from ADI-001 Phase 1 Trial at the American Society of Clinical Oncology Annual Meeting adicetbio.com ↗
When we look at the totality of these early data, we have an indicator that allogeneic gamma-delta CAR T cell therapy like ADI-001 could be a significant advance. |
| 2022-05-26 | Adicet Therapeutics | Results Adicet Bio Reports Positive Clinical Update from ADI-001 Phase 1 Trial in Relapsed/Refractory Non-Hodgkin’s Lymphoma (NHL) adicetbio.com ↗
As of the February 14, 2022 ASCO abstract data-cut date, ADI-001 demonstrated a 67% complete response rate with positive preliminary durability data and a favorable safety and tolerability profile |
| 2022-05-05 | Adicet Therapeutics | Results Adicet Presents Preclinical Data at the ISCT Annual Meeting Highlighting Potential Advantages of the Non-Gene-Edited Approach for its Investigational Allogeneic Gamma Delta CAR T Cell Therapy Targeting CD20 for B Cell Malignancies adicetbio.com ↗
ADI-001 exhibited robust in vitro and in vivo tumor growth inhibition in multiple human lymphoma cell lines, with adaptive and innate mechanisms contributing to its anti-tumor activity |
| 2022-04-19 | Adicet Therapeutics | Regulatory Adicet Bio Receives FDA Fast Track Designation for Lead Candidate ADI-001 adicetbio.com ↗
Adicet Bio, Inc. (Nasdaq: ACET), a clinical stage biotechnology company discovering and developing first-in-class allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapies for cancer, today announced the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation to its lead program ADI-001, an investigational therapy targeting CD20 for the potential treatment of relapsed or refractory B-cell Non-Hodgkin’s lymphoma (NHL). |
| 2021-12-06 | Adicet Therapeutics | Results Adicet Bio Announces Positive Interim Clinical Data From First-Ever Allogeneic, Off-The-Shelf, Gamma Delta CAR T Investigational Cell Therapy adicetbio.com ↗ |
| 2020-10-22 | Adicet Therapeutics | Regulatory Adicet Announces FDA Clearance of IND Application for First-in-Class Allogeneic CAR Gamma-Delta T Cell Therapy adicetbio.com ↗ |
All press releases naming this drug 28 releases
Evidence & citations 5 cited values
Every value below carries the sentence it was read from. 3 sources stand behind the page.
| Field | Value | Cited text |
|---|---|---|
| Known as | ADI-001 | ClinicalTrials.gov intervention name — accepted as the source's own label NCT07100873 ↗ |
| Known as | Prula-cel | “A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease” NCT06375993 ↗ |
| Known as | Prulacabtagene Leucel | “A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease” NCT06375993 ↗ |
| Modality | Cell therapy | “ADI-001 is an investigational immunotherapy composed of allogeneic gamma delta T cells” NCT04735471 ↗ |
| Route | Other | “ADI-001 is administered via infusion with ascending dose levels as a single dose” NCT06375993 ↗ |