Building a broad pipeline in autoimmune
diseases & cancer

Pipeline

Adicet Bio Pipeline graphic

*Adicet is focused on advancing MCL enrollment in the GLEAN trial and has deprioritized enrolling large B-cell lymphoma patients. 
+ Regeneron exercised its option to license the exclusive worldwide rights to ADI-002

HCC: Hepatocellular carcinoma; mCRPC: Metastatic castration-resistant prostate cancer; MICA/MICB: Major histocompatibility complex (MHC) Class I chain-related protein A/B; NHL: Non-Hodgkin's lymphoma; PSMA: Prostate-specific membrane antigen; RCC: Renal cell carcinoma; ST: Solid tumor; ULBP: UL16 binding protein

Adicet Bio is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer.

Adicet is advancing a pipeline of “off-the-shelf” gamma delta T cells, engineered with chimeric antigen receptors (CARs), to facilitate durable activity in patients.

ADI-001

Our lead product candidate, ADI-001, is a first-in-class investigational allogeneic gamma delta CAR T cell therapy currently being developed in two indications. It’s being studied in an ongoing Phase 1 trial for the treatment of relapsed or refractory aggressive B-cell NHL and in a Phase 1 study in lupus nephritis (an autoimmune disease caused by systemic lupus erythematosus (SLE)).

In Autoimmune Diseases

ADI-001 is ideally suited for the treatment of autoimmune diseases given its robust B-cell depletion consistent with other autologous CAR T therapies tested in autoimmune diseases, its tissue tropism potential, and the safety data observed in our oncology Phase 1 study.

FDA cleared the IND application for ADI-001 in lupus nephritis in December, 2023. Adicet plans to initiate a Phase 1 study to evaluate the safety and efficacy of ADI-001 in lupus nephritis in Q2 2024.

In Cancer

ADI-001 targets malignant B-cells with an anti-CD20 CAR via the gamma delta innate and T cell endogenous cytotoxicity receptors. Gamma delta T cells engineered with an anti-CD20 CAR have demonstrated potent antitumor activity in preclinical models, leading to long-term control of tumor growth.

ADI-001 has shown encouraging early efficiacy and favorable safety in heavily pretreated aggressive NHL patients in initial Phase 1 clinical studies.

In April 2022, ADI-001 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of relapsed or refractory B-cell NHL.

ADI-001

ADI-270

  • ADI-270, an armored CD70 CAR γδ T cell targeting CD70 via the CD27-ligand, has shown superiority to scFv (single-chain variable fragment) CARs1
  • Innate and adaptive targeting mechanisms associated with activity in solid tumors such as renal cell carcinoma (RCC) and other indications
  • Armoring via dominant negative receptor; addresses TGFβ in Tumor Microenvironment
  • Lead CAR demonstrated potency and improved serial killing, and resilience against suppressive factors and graft vs host rejection
  • Homing and activity of gamma delta 1 T cells demonstrated in RCC


1​ Sauer et al. Blood (2021)
2 Junker et al. Cytokine (2000)


Armored PSMA CAR Gamma Delta T Cell Program

  • Potent CAR construct active against heterogeneous PSMA
  • Three mechanisms of action designed to address tumor heterogeneity
  • Homing of gamma delta 1 T cells documented in mCRPC
  • Inclusion of armoring to address suppressive TME
  • No significant CRS and ICANS demonstrated with Adicet CAR gamma delta 1 T cells in clinical trials reported to-date



Liu et al. Cancer Res. (1997)

Expanded Access Policy

Expanded Access refers to the use of an investigational therapy outside of a clinical trial for potential treatment of a serious or life-threatening condition. Adicet is a clinical stage biotechnology company discovering and developing allogeneic gamma delta T cell therapies for autoimmune diseases and cancer. Consistent with our commitment to bring innovative, safe, and effective therapies to patients, we are focused on conducting the clinical trials necessary to gain regulatory approvals to make our therapies available to patients as quickly as possible. Participation in one of our clinical trials is the best way to access Adicet gamma delta T cell investigational therapies. As such, Adicet does not provide access to our investigational therapies on an Expanded Access basis at this time.

We encourage patients interested in our investigational therapies to learn more about our ongoing studies by visiting clinicaltrials.gov. Treating physicians may request additional information about Adicet’s Expanded Access policy by contacting inquiries@adicetbio.com

Presentations and Publications

ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Candidate Designed for Multiple Solid and Hematological Cancer Indications
ASGCT Oral Presentation | 2024

ADI-270: An Armored Allogeneic Anti-CD70 CAR γδ T cell Therapy Designed for Multiple Solid and Hematological Cancer Indications
ASGCT Abstract | 2024

Expansion, Persistence and Pharmacodynamic Profile of ADI-001, a First-in-Class Allogeneic CD20-targeted CAR Gamma Delta T Cell Therapy, in Patients with Relapsed/Refractory Aggressive B-cell Non-Hodgkin’s Lymphoma 
ASH Poster | 2023

ADI-925: an allogeneic off-the-shelf Chimeric Adapter (CAd) γδ T cell therapy targeting NKG2D ligand-expressing cancers
SITC Poster | 2023

Assay qualification and quantitative detection of ADI-001, a CD20-targeted γδ1 CAR T therapy, using AlloCell, a universal assay for monitoring of off-the-shelf allogeneic cell therapies
SITC Poster | 2023

Disruption of the cytokine signaling checkpoint CIS enhances serial-killing and anti-tumor activity of CAR-engineered γδ T cells
SITC Poster | 2023

Characterization of Allogeneic CAR γδ1 T Cell Therapy for Prostate Cancer Targeting a Novel Dimeric Epitope on PSMA (Prostate-Specific Membrane Antigen)
EORTC-NCI-AACR Poster | 2023

ADI-270: an armored allogeneic “off-the-shelf” CAR γδ T cell therapy targeting CD70+ cancers
ASGCT Poster | 2023

Preclinical Discovery And Evaluation of Allogeneic “off-the-shelf” γδ CAR T Cells Targeting B7-H6Tumors
SITC Poster | 2022

Allogeneic “off-the-shelf” γδ T cells modified with CD27-containing CAR for targeting CD70+ cancers
SITC Poster | 2022

Innate-Enhanced Chimeric Adaptors (CAd): A Newly-Described Approach for Augmenting Potency of γδ T Cell Immunotherapy
SITC Poster | 2022

Preclinical Discovery and Characterization of Allogeneic Anti-PSMA γδ CAR-T Therapy for Prostate Cancer
SITC Poster | 2022

A Phase 1 Study of ADI-001: Anti-CD20 CAR-Engineered Allogeneic Gamma Delta1 (γδ) T Cells in Adults with B-Cell Malignancies
ASH Abstract | 2022

A Phase 1 Study of ADI-001: Anti-CD20 CAR-engineered Allogeneic Gamma Delta (γδ) T cells in Adults with B Cell Malignancies
ASCO Abstract | 2022

Evaluation of non-gene edited allogeneic “off-the-shelf” Vδ1 γδ CAR T cells targeting CD20 for B cell malignancies
ISCT Poster | 2022

Allogeneic CD20-targeted γδ T cells exhibit innate and adaptive antitumor activities in preclinical B-cell lymphoma models
Clinical & Translational Immunology (CTI) | 2022

Off-the-shelf Vδ1 gamma delta T cells engineered with glypican-3 (GPC-3)- specific chimeric antigen receptor (CAR) and soluble IL-15 display robust antitumor efficacy against hepatocellular carcinoma
JITC | 2021

Gammaretroviral and lentiviral vector manufacture: brief overview
Cell and Gene Therapy Insights | 2021

Effects of IL-2 and IL-15 on the proliferative and antitumor capacities of allogeneic anti-CD20 CAR-engineered γδ T cells in a 3D B cell lymphoma spheroid assay
SITC Poster | Spheroids 10 video | 2020

A Novel γδT Cell Product Targeting CD20 for the Treatment of B Cell Malignancies
ASGCT Poster | 2019

Leveraging Bioprocess Platform Technology for the Development of a Robust, Scalable, and Economic Manufacturing Process of Allogeneic CAR-T Cell Therapy Products
ECI Poster | 2019

T-cell Receptor-like Antibodies Directed Against Intracellular Tumor Targets for Immunotherapy of Solid Tumors
PEGS Boston Poster | 2019