Adicet Bio (ACET) has upcoming FDA regulatory milestones for ADI-001 and ADI-212. The table below outlines estimated target dates and event types for these pending regulatory actions.
This section highlights FDA-related milestones and regulatory updates for drugs developed by Adicet Bio (ACET).
Over the past two years, Adicet Bio has reported clinical trial outcomes, regulatory submissions, approvals, and other FDA events for drugs and therapies such as
ADI-212, ADI-001, and ADI-270. For definitions of regulatory abbreviations such as NDA, BLA, or PDUFA, see the event status legend.
Select a button below to view the list of FDA events for that drug.
ADI-212 FDA Regulatory Events
ADI-212 is a drug developed by Adicet Bio for the following indication: treatment of patients with metastatic castration-resistant prostate cancer.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADI-212
- Announced Date:
- August 27, 2026
- Target Action Date:
- Q4 2026
- Estimated Target Date Range:
- October 1, 2026 - December 31, 2026
- Indication:
- treatment of patients with metastatic castration-resistant prostate cancer
Announcement
Adicet Bio, Inc. announced that The Company plans to initiate Phase 1 enrollment in patients with mCRPC in the fourth quarter of 2026.
Read Announcement- Drug:
- ADI-212
- Announced Date:
- August 27, 2026
- Indication:
- treatment of patients with metastatic castration-resistant prostate cancer
Announcement
Adicet Bio, Inc. announced that the U.S. Food and Drug Administration (FDA) has cleared the Company’s Investigational New Drug (IND) application for ADI-212 for the treatment of patients with metastatic castration-resistant prostate cancer (mCRPC).
Read Announcement
ADI-001 FDA Regulatory Timeline and Events
ADI-001 is a drug developed by Adicet Bio for the following indication: B cell non-Hodgkin's lymphoma (NHL).
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADI-001
- Announced Date:
- October 16, 2025
- Target Action Date:
- H2 2026
- Estimated Target Date Range:
- July 1, 2026 - December 31, 2026
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc. announced that Preliminary clinical data from the Phase 1 trial expected in 2H/2026
AI Summary
Adicet Bio, Inc. has dosed the first patient in its Phase 1 trial of ADI-001 for treatment-refractory rheumatoid arthritis. This study will assess how safe and tolerable the allogeneic gamma delta T cell therapy is in patients whose disease has not responded to standard treatments.
The trial uses two conditioning regimens—cyclophosphamide alone and cyclophosphamide combined with fludarabine—to explore their effects on patient outcomes. Primary goals include measuring safety and tolerability. Researchers will also track cellular kinetics, pharmacodynamics, and changes in disease activity scores to gauge preliminary efficacy.
Adicet is enrolling patients across seven autoimmune conditions, building on encouraging results in lupus nephritis and systemic lupus erythematosus. The company expects to report preliminary clinical data from this Phase 1 rheumatoid arthritis trial in the second half of 2026.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- October 16, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc. announced that the first patient has been dosed in its Phase 1 clinical trial evaluating ADI-001 in treatment-refractory RA.
AI Summary
Adicet Bio, Inc. has dosed the first patient in its Phase 1 clinical trial testing ADI-001 for treatment-refractory rheumatoid arthritis (RA). The trial aims to assess safety, tolerability and early signs of efficacy. Preliminary clinical data are expected in the second half of 2026.
Participants will receive one of two conditioning regimens: cyclophosphamide alone or cyclophosphamide combined with fludarabine. Researchers will monitor how ADI-001 cells behave in the body, measure pharmacodynamic effects, and track changes in disease activity scores over time.
This RA study is part of a broader Phase 1 program evaluating ADI-001 in seven autoimmune conditions, including lupus nephritis and systemic lupus erythematosus. Positive early results in those indications have encouraged the company to explore ADI-001’s potential to improve outcomes across diverse autoimmune diseases.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- October 7, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced initial safety and efficacy data from the first seven patients dosed with ADI-001 in the ongoing Phase 1 study evaluating ADI-001 as a potential treatment for patients with autoimmune diseases.
AI Summary
Adicet Bio announced initial safety and efficacy data from the first seven patients dosed with ADI-001 in an ongoing Phase 1 study for autoimmune diseases. Among five lupus nephritis (LN) and two systemic lupus erythematosus (SLE) patients, all seven experienced rapid, sustained drops in disease activity scores (SLEDAI-2K and PGA). All five LN patients showed improved kidney function, including three complete renal responses with DORIS remissions and two partial responses, all ongoing.
ADI-001 was generally well tolerated: there were no serious adverse events, no immune effector cell-associated neurotoxicity syndrome (ICANS), and only two Grade 1 cytokine release syndrome (CRS) cases. All patients stopped immunosuppressants and tapered corticosteroids to physiological levels. A clear immune reset was seen, with new naïve B cell repertoires emerging after a single dose.
With over 25 sites open for enrollment, Adicet plans to request an FDA meeting in early 2026 to inform a Phase 2 pivotal trial, aiming to start in mid-2026. If confirmed, ADI-001 could offer an off-the-shelf, one-time therapy for autoimmune diseases.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- July 24, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced that the first systemic sclerosis (SSc) patient has been dosed in the second cohort of the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
AI Summary
Adicet Bio, Inc. announced that the first systemic sclerosis (SSc) patient has been dosed in the second cohort of its Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases. This milestone marks a key step in testing the safety and tolerability of ADI-001, an allogeneic gamma delta CAR T cell therapy designed to target B cells via an anti-CD20 receptor.
The ongoing trial features four separate arms: lupus nephritis and systemic lupus erythematosus in the first, SSc in the second, idiopathic inflammatory myopathies and stiff person syndrome in the third, and antineutrophil cytoplasmic antibody–associated vasculitis in the fourth. Each enrolled patient receives a single dose, with safety assessments through Day 28 and follow-up visits at months 3, 6, 9, 12, 18, and 24. Early enrollment in the lupus nephritis and lupus cohorts is strong, and preliminary data are expected in the second half of 2025.
ADI-001 has earned Fast Track designation from the U.S. Food and Drug Administration for treating relapsed or refractory lupus nephritis, refractory systemic lupus erythematosus, and SSc. Adicet believes this innovative approach could deliver transformative benefits for patients with debilitating autoimmune conditions.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- March 6, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc reported operational highlights
AI Summary
Adicet Bio, Inc. shared updates on progress in advancing its ADI-001 Phase 1 clinical trial for autoimmune diseases. The trial is now enrolling patients, with the first lupus nephritis (LN) patient having already received treatment. The company expects to report preliminary LN clinical data in the first half of 2025. In addition, further data from additional autoimmune cohorts will be released in the second half of the year as patient enrollment increases. Enrollment is also planned to open for patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), idiopathic inflammatory myopathy (IIM), and stiff person syndrome (SPS) in the second quarter. Meanwhile, patient enrollment for anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV) is scheduled for the latter half of 2025. These operational highlights show Adicet Bio’s strong commitment to developing off-the-shelf therapies for patients with high unmet needs.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- February 27, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc 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).
AI Summary
Adicet Bio, Inc. recently received Fast Track Designation from the U.S. Food and Drug Administration (FDA) for its investigational therapy ADI-001, which is developed to treat adult patients with systemic sclerosis (SSc). This designation is designed to speed up the development and review process for drugs that address serious conditions and have an unmet medical need. ADI-001 is an allogeneic gamma delta CAR T cell therapy targeting CD20 and is being explored for multiple autoimmune diseases. The Fast Track status is expected to help streamline the path toward regulatory approval, ensuring that promising treatment options for systemic sclerosis and other autoimmune conditions can reach patients quicker. This milestone reflects the ongoing efforts by Adicet Bio to innovate in the field of immunotherapy and improve outcomes for those suffering from severe autoimmune diseases.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- February 5, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc 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.
AI Summary
Adicet Bio, Inc. announced that the FDA has granted Fast Track Designation to its investigational therapy ADI-001 for treating adult patients with refractory systemic lupus erythematosus (SLE) with extrarenal involvement. This designation is designed to speed up drug development and review for treatments that address serious conditions and unmet medical needs.
ADI-001 is an allogeneic gamma delta chimeric antigen receptor (CAR) T cell therapy that targets CD20. The Fast Track status highlights the potential of ADI-001 in offering a new treatment option for patients who have not responded to existing therapies. This step could help accelerate important clinical research efforts in managing SLE, particularly for patients with complications outside of the kidneys.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- January 8, 2025
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio Highlights Key 2025 Milestones Following 2024 Progress
AI Summary
Adicet Bio made strong progress in 2024 and is setting clear milestones for 2025. The company advanced its Phase 1 trial of ADI‑001 by expanding its evaluation to six autoimmune diseases. In 2025, they plan to share preliminary data from lupus nephritis patients in the first half of the year, with additional results from other patient groups expected later.
Enrollment for patients with systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, and stiff person syndrome is expected to begin in early 2025, while patient enrollment for anti-neutrophil cytoplasmic autoantibody‐associated vasculitis will start by the second half. Additionally, Adicet is progressing with its oncology pipeline by initiating a Phase 1 trial for ADI‑270 in metastatic/advanced clear cell renal cell carcinoma, with updates anticipated soon.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- November 18, 2024
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced that the first LN patient has been dosed in the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
AI Summary
Adicet Bio, Inc. has reached a significant milestone in its Phase 1 clinical trial evaluating ADI-001, an allogeneic gamma delta CAR T cell therapy for autoimmune diseases. The company announced that the first lupus nephritis (LN) patient has been dosed, marking an important step forward in the study.
This early dosing is part of a broader trial that will also eventually include patients with systemic lupus erythematosus, systemic sclerosis, idiopathic inflammatory myopathy, stiff person syndrome, and ANCA-associated vasculitis. Preliminary clinical data for LN is expected in the first half of 2025, with additional enrollment for other autoimmune conditions planned to start in early 2025. Dr. Francesco Galimi, Senior Vice President and Chief Medical Officer of Adicet Bio, emphasized that this achievement is a key move toward offering a transformative off-the-shelf treatment option for patients with autoimmune diseases.
Read Announcement - Drug:
- ADI-001
- Announced Date:
- November 16, 2024
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced that clinical biomarker data from the ADI-001 Phase 1 GLEAN trial which demonstrates robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion in secondary lymphoid tissue will be featured in an oral session at ACR Convergence 2024 in Washington, D.C., November 14-19.
AI Summary
Adicet Bio, Inc. announced that key clinical biomarker data from its ADI-001 Phase 1 GLEAN trial will be presented in an oral session at ACR Convergence 2024 in Washington, D.C. between November 14 and 19. The trial results demonstrate robust tissue homing, significant CAR T cell activation, and complete CD19+ B cell depletion within secondary lymphoid tissue. These findings highlight the potential of ADI-001, a gamma delta CAR T cell therapy, as an effective treatment for autoimmune diseases. The data suggest that ADI-001 may offer improved drug exposure in tissues and a more thorough depletion of problematic B cells compared to current therapies. This evidence supports the case for further development and exploration of ADI-001 in a basket study covering multiple autoimmune indications, addressing critical unmet needs in patient care.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- September 30, 2024
- Target Action Date:
- Q4 2024
- Estimated Target Date Range:
- October 1, 2024 - December 31, 2024
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced that Enrollment open for patients with LN; enrollment in SLE, SSC, and AAV expected to open in the fourth quarter of 2024
AI Summary
Adicet Bio, Inc has announced that enrollment is now open for patients with lupus nephritis (LN) in its Phase 1 clinical trial evaluating the investigational ADI-001 therapy for autoimmune diseases. This trial aims to assess the safety and potential effectiveness of ADI-001, an allogeneic gamma delta T cell therapy designed to treat LN, a severe kidney complication of lupus.
The company also shared that enrollment for patients with systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic autoantibody-associated vasculitis (AAV) is expected to open in the fourth quarter of 2024. Adicet Bio is expanding its clinical sites gradually, with additional locations set to open by the end of 2024 and into early 2025, promising to provide more opportunities for patients battling these autoimmune conditions.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- September 30, 2024
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-001 in autoimmune diseases.
AI Summary
Adicet Bio, Inc. announced that it is now enrolling patients in a Phase 1 clinical trial of ADI-001, an experimental allogeneic gamma delta CAR T cell therapy, to treat several autoimmune diseases. Initially, the trial will focus on patients with lupus nephritis (LN), with plans to begin enrollment for systemic lupus erythematosus (SLE), systemic sclerosis (SSc), and anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis (AAV) in the fourth quarter of 2024.
The study is structured into three separate arms based on the patients’ conditions, aiming to evaluate the safety and tolerability of ADI-001. Researchers will also assess cellular kinetics and other disease markers to understand how the treatment reduces B cells in peripheral blood and lymphoid tissues. Preliminary clinical data from this trial are expected to be reported in the first half of 2025.
Read Announcement- Drug:
- ADI-001
- Announced Date:
- September 19, 2024
- Indication:
- B cell non-Hodgkin's lymphoma (NHL)
Announcement
Adicet Bio, Inc announced ADI-001 clinical biomarker data from the Phase 1 GLEAN trial which further reinforces the potential of ADI-001 as a best-in-class allogeneic cell therapy for autoimmune diseases.
AI Summary
Adicet Bio, Inc. announced promising new data from the Phase 1 GLEAN trial for their ADI-001 therapy. The results show that ADI-001, an allogeneic cell therapy, demonstrates strong potential as a best-in-class treatment for autoimmune diseases. The trial data revealed robust tissue trafficking, high levels of ADI-001, and significant chimeric antigen receptor (CAR) T cell activation. Notably, there was a complete depletion of CD19+ B cells in secondary lymphoid tissue, which is a key advantage as current therapies have struggled to achieve this within tissues.
Dr. Blake Aftab, the company’s Chief Scientific Officer, emphasized that these findings support the superior tissue exposure and activation of ADI-001 compared to other CAR T therapies. The results provide multiple layers of evidence that could help extend effective B cell targeting into tissues for patients with autoimmune conditions.
Read Announcement
ADI-270 FDA Regulatory Timeline and Events
ADI-270 is a drug developed by Adicet Bio for the following indication: An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers.
This drug is under review by the U.S. Food and Drug Administration (FDA).
Below is a timeline of key regulatory milestones for this therapy.
- Drug:
- ADI-270
- Announced Date:
- April 28, 2025
- Indication:
- An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers
Announcement
Adicet Bio, Inc announced the acceptance of an abstract for an oral presentation at the upcoming American Society of Gene & Cell Therapy (ASGCT) Annual Meeting taking place May 13-17, 2025, in New Orleans, LA.
AI Summary
Adicet Bio, Inc. recently announced that an abstract from its research has been accepted for an oral presentation at the American Society of Gene & Cell Therapy (ASGCT) Annual Meeting. The event will be held in New Orleans, LA, from May 13-17, 2025, providing a platform for sharing important advancements in cell therapies.
The accepted presentation is titled "ADI-270, an Armored Allogeneic Anti-CD70 CAR γδ T Cell Therapy, Demonstrates Robust CAR-Directed and -Independent Anti-Tumor Activity Against Hematologic and Solid Tumor Models Compared to Conventional CAR αβ T Cells." It will take place during the Engineered Immune Effector Cells for Solid Tumors session and is set for May 17, 2025, from 11:45 a.m. to 12:00 p.m. CT. Melinda Au will serve as the presenting author, highlighting key innovations in CAR technology focused on improving treatments for both blood and solid tumors.
Read Announcement- Drug:
- ADI-270
- Announced Date:
- March 3, 2025
- Indication:
- An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers
Announcement
Adicet Bio, Inc. announced the acceptance of two abstracts for poster presentations at the upcoming Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting taking place March 12-14, 2025, in San Diego, C.A.
AI Summary
Adicet Bio, Inc., a clinical stage biotechnology company, announced that two of its posters have been accepted for presentation at the Society for Immunotherapy of Cancer (SITC) 2025 Spring Scientific Meeting in San Diego, CA, from March 12-14, 2025. These presentations will showcase the company’s innovative work on gamma delta T cell therapies.
The first abstract, titled "ADI-270, an Armored Allogeneic Anti-CD70 γδ CAR T Cell Therapy, Demonstrates Improved Efficacy and Safety in Preclinical Models Compared to Conventional αβ CAR Benchmarks," will be presented by Dr. Shon Green on March 12, 2025, from 5:10 p.m. to 6:45 p.m. PT. The second poster, titled "A Phase 1/2 First in Human Study of ADI-270, an Armored Allogeneic Anti-CD70 Chimeric Antigen Receptor γδ T Cell Therapy, in Relapsed or Refractory (R/R) Clear Cell Renal Cell Carcinoma (ccRCC)," will be presented by Dr. Gregory Vosganian on March 13, 2025, from 5:00 p.m. to 6:30 p.m. PT.
Read Announcement- Drug:
- ADI-270
- Announced Date:
- December 19, 2024
- Indication:
- An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers
Announcement
Adicet Bio, Inc announced that the first patient has been dosed in the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced ccRCC.
AI Summary
Adicet Bio, Inc. recently announced a significant milestone in its clinical efforts by dosing the first patient in a Phase 1 trial of its new treatment, ADI-270, for metastatic or advanced clear cell renal cell carcinoma (ccRCC). This trial marks the beginning of a study aimed at assessing the safety, tolerability, and anti-tumor activity of ADI-270, a gamma delta CAR T cell therapy designed to target CD70-positive cancers.
The treatment is administered after lymphodepletion, and patients may receive a second dose if they meet specific criteria. Early preclinical data have shown that ADI-270 effectively infiltrates tumors and resists the immunosuppressive tumor microenvironment, offering hope for improved outcomes in ccRCC. Preliminary clinical data from the trial is expected in the first half of 2025, which could signal a promising advancement in treating solid tumors.
Read Announcement- Drug:
- ADI-270
- Announced Date:
- November 18, 2024
- Indication:
- An Armored Allogeneic "Off-the-Shelf" CAR gamma delta T Cell therapy Targeting CD70+ Cancers
Announcement
Adicet Bio, Inc announced the opening of enrollment for the Phase 1 clinical trial evaluating ADI-270 in patients with metastatic/advanced clear cell renal cell carcinoma (ccRCC).
AI Summary
Adicet Bio, Inc. has opened enrollment for a Phase 1 clinical trial testing its new treatment, ADI-270, in patients with metastatic or advanced clear cell renal cell carcinoma (ccRCC). ADI-270 is an innovative, “off-the-shelf” gamma delta CAR T cell therapy designed to target CD70-positive cancers. During the trial, patients will first receive a lymphodepletion treatment, followed by an initial single dose of ADI-270. Those meeting specific criteria may receive a second dose, allowing the study to evaluate the drug’s safety, tolerability, and pharmacokinetics, as well as its anti-tumor effectiveness. Researchers are hopeful that this study will demonstrate promising results, with preliminary data expected in the first half of 2025. This trial represents a significant step forward in exploring new treatments for solid tumors like ccRCC.
Read Announcement
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