Adicet Bio Advances Gamma Delta T Cell Therapy Pipeline with FDA Alignment and 2026 Milestones
Key Insights
Adicet Bio secured FDA alignment to enable outpatient dosing of prulacabtagene leucel (search) (prula-cel) for systemic lupus erythematosus (search) and lupus nephritis (search) patients, expanding treatment accessibility.
The company's Phase 1 autoimmune program now enrolls across seven disease cohorts with over 20 patients enrolled as of December 31, 2025, more than doubling since October data release.
Clinical updates from the prula-cel autoimmune program are expected in both halves of 2026, with plans to initiate a pivotal study in lupus nephritis (search) or combined lupus conditions in the second half of 2026.
Adicet Bio has achieved significant regulatory alignment with the FDA and outlined ambitious 2026 milestones for its allogeneic gamma delta T cell therapy pipeline, positioning the clinical-stage biotechnology company for potential pivotal studies in autoimmune diseases while advancing its solid tumor program.
The company successfully completed meetings with the FDA in November 2025 to enable outpatient dosing of prulacabtagene leucel (search) (prula-cel, formerly ADI-001) for systemic lupus erythematosus (search) (SLE) and lupus nephritis (search) (LN) patients in ongoing and future clinical studies. This regulatory alignment represents a significant advancement in treatment accessibility for patients with these challenging autoimmune conditions.
Expanding Autoimmune Disease Program Shows Strong Enrollment
Adicet's Phase 1 autoimmune program has demonstrated robust enrollment momentum, with all seven cohorts now actively enrolling patients. The program encompasses LN, SLE, systemic sclerosis (search) (SSc), idiopathic inflammatory myopathy (IIM), stiff person syndrome (SPS), anti-neutrophil cytoplasmic autoantibody (ANCA) associated vasculitis (AAV), and treatment-refractory rheumatoid arthritis (search) (RA).
"Since reporting data in October from our prula-cel Phase 1 program in autoimmune diseases, enrollment has more than doubled with over 20 patients as of December 31, 2025," said Chen Schor, President and Chief Executive Officer of Adicet Bio. The company recently dosed its first AAV patient, marking another milestone in the comprehensive autoimmune program.
Prula-cel has received Fast Track Designation from the FDA for the potential treatment of relapsed/refractory class III or class IV LN, refractory SLE with extrarenal involvement, and SSc, underscoring the regulatory agency's recognition of the unmet medical need in these conditions.
Promising Early Clinical Data Supports Continued Development
In October 2025, Adicet reported positive preliminary safety and efficacy data from the Phase 1 clinical trial of prula-cel in patients with LN and SLE. The data demonstrated rapid and sustained reductions in Systemic Lupus Erythematosus (search) Disease Activity Index (SLEDAI-2K) score and Physician's Global Assessment (PGA), along with improved renal function and a favorable safety and tolerability profile as of the August 31, 2025 data cut-off date.
The company is also exploring innovative approaches to enhance patient experience through its treatment-refractory RA study, which evaluates two conditioning regimens: cyclophosphamide alone versus cyclophosphamide with fludarabine. The primary objectives focus on evaluating safety and tolerability of prula-cel, with secondary objectives including cellular kinetics, pharmacodynamics, and disease activity scores.
Solid Tumor Pipeline Advances with Novel Engineering Approach
Adicet continues advancing preclinical development of ADI-212 (search), a next-generation gene-edited and armored clinical candidate designed to target prostate-specific membrane antigen (search) for metastatic castration-resistant prostate cancer (search) (mCRPC). ADI-212 incorporates sophisticated engineering features, including a novel CAR binder designed for enhanced tolerability and tumor-specific recognition.
The therapy integrates membrane-tethered IL-12 armoring and CRISPR/Cas9 mediated disruption of subunit 12 of the mediator complex (MED12 (search)) to enhance potency in solid tumors and deliver multiple anti-tumor mechanisms of action within the tumor microenvironment. In October 2025, Adicet presented preclinical data from ADI-212 (search) at the 32nd Annual Prostate Cancer Foundation Scientific Retreat, supporting its design elements and functional enhancements in multiple disease models.
Strategic 2026 Milestones Target Regulatory Advancement
Adicet has outlined comprehensive strategic priorities for 2026, beginning with clinical data presentations from the Phase 1 prula-cel study throughout the year. The company remains on track to share clinical updates in LN, SLE, and SSc in the first half of 2026, followed by an additional clinical update in the second half of 2026.
The company plans to request an FDA meeting in the second quarter of 2026 to inform potential pivotal trial design. Subject to regulatory clearance, Adicet expects to initiate a pivotal study in LN or combined LN and SLE patients in the second half of 2026. Additionally, a clinical update on the Phase 1 RA study is expected in the second half of 2026.
For ADI-212 (search), Adicet expects to submit a regulatory filing for mCRPC treatment in the first half of 2026, with clinical startup activities planned for the second quarter of 2026, subject to regulatory clearance.
Financial Position Supports Extended Development Timeline
In October 2025, Adicet successfully raised approximately $74.8 million in net proceeds through an underwritten registered direct offering of equity securities, extending its cash runway into the second half of 2027. This financial foundation provides the company with resources to execute its ambitious 2026 milestones and advance its pipeline of "off-the-shelf" gamma delta T cells engineered with chimeric antigen receptors (CARs) to facilitate durable activity in patients.