A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease

Enrolling by invitation · Phase 1

Conditions studied: Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies, Stiff Person Syndrome

In brief

ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up

Key facts

Study ID: NCT06375993
Run by: Adicet Therapeutics
People needed: 180
Starts: 2024-11-10
Expected to finish: 2027-12-01
Last updated by the study team: 2026-03-19

Who can join

Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

For Cohort 1: Subjects with LN:
Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019).
Have unequivocally positive anti-nuclear antibody (ANA) test results defined as an ANA titer ≥ 1:80 (based on Hep-2 immunofluorescence assay or equivalence by enzyme-linked immunosorbent assay (ELISA), and/or positive anti-dsDNA (≥ 30 IU/mL based on ELISA.
Historical ANA and anti-dsDNA results (defined as within the 2 years prior to enrollment) may be used for eligibility. During screening a specimen will be collected.
Active kidney disease with biopsy-proven active LN Class III or IV (coexistent class V permitted) (per 2018 International Society of Nephrology [ISN]/Renal Pathology Society [RPS] criteria); biopsy should be performed within 6 months before enrolling in the study.
Proteinuria (or urine protein creatinine ratio [UPCR]) > 1g / 24 hours.
LN showing inadequate response to current standard of care, defined per 2023 EULAR/ERA-EDTA recommendations as:
Failure following at least two lines of standard of care therapies for LN (including at least one being mycophenolate or cyclophosphamide or a biologic at doses and durations of treatment per local standard of care.
Adequate renal function, including:
Estimated creatinine clearance ≥ 45 mL/min as calculated using the method standard for the institution, or equivalent estimated glomerular filtration rate (eGFR) determination.
Proteinuria ≤ 8 g/24 h or UPCR ≤ 8 in a spot urine.
Adequate pulmonary function defined saturated oxygen (SpO2) ≥ 93% on room air.
For Cohort 1: Subjects with SLE with Extrarenal Involvement
Clinical diagnosis of systemic lupus erythematosus (SLE) per 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria (Aringer 2019).
Positive anti-nuclear antibody (ANA) test results and/or a positive anti-dsDNA and/or anti-Smith antibodies above the ULN.
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 with a clinical SLEDAI-2K score (SLEDAI-2K not including points for anti-dsDNA and/or low complement) ≥ 6 and/or ≥ 1 British Isles Lupus Assessment Group (BILAG)-2004 Category A AND physician's global assessment of SLE disease activity score ≥ 1.5 (on a 0 to 3 visual analogue scale).
Inadequate response in terms of active disease despite treatment with current standard of care for SLE including corticosteroids and at least 2 SLE therapy.
Estimated creatinine clearance ≥ 60 mL/min AND Proteinuria ≤ 1 g/24 h or UPCR ≤ 1 in a spot urine.
Adequate pulmonary function defined saturated oxygen (SpO2) ≥ 93% on room air.
For Cohort 2: Subjects with SSc
Disease duration ≤ 6 years (from onset of first non-Raynaud manifestation)
Subjects with diffuse cutaneous SSc, must meet both of the following criteria: mRSS ≥ 15 at screening AND one of the following within 6 months prior to screening: (i) mRSS increase of ≥ 3 units in the total mRSS, OR (ii) Involvement of 1 new body area, OR (iii) Increase in mRSS ≥ 2 units in 1 body area
Subjects with diffuse or limited cutaneous SSc and ILD must meet both of the following criteria: ILD, defined as evidence of fibrosis on HRCT within 4 months of screening AND Progression of ILD by FVC or HRCT in previous 24 months:
Relative decline in FVC of 10% predicted or more OR 5% to <10% and worsening respiratory symptoms OR relative decline in FVC of 5% to <10% and any increased extent of fibrosis on HRCT OR Worsening of respiratory symptoms and any increased extent of fibrosis on HRCT.
Inadequate response to at least one (1) of the following medications administered at the appropriate dose for at least 3 months within 24 months prior to screening: mycophenolate mofetil or its derivatives, cyclophosphamide, tocilizumab, rituximab, azathioprine, methotrexate.

You may not qualify if…

For all Subjects:
Presence of severe liver disease, Child-Pugh class B or C.
Prior treatment with any gene therapy, genetically modified cell therapy, or adoptive T cell therapy.
Autoimmune disease requiring prednisone higher than 0.5 mg/kg/day (or corticosteroid equivalent).
Subjects unwilling to participate in an extended safety monitoring period (LTFU protocol)
History of a clinically significant infection (including sepsis, pneumonia, bacteremia, fungal, viral and opportunistic infections) within 4 weeks prior to first dose of study drug which in the opinion of the Investigator may compromise the safety of the subject in the study.
Radiation therapy within 1 week prior to study entry.
Autologous stem cell transplant (auto-SCT) within 6 weeks of planned prulacabtagene leucel (prula-cel) infusion.
History of any form of primary immunodeficiency such as severe combined immunodeficiency disease.
History of any one of the following cardiovascular conditions within the past 6 months: Class III or IV heart failure as defined by the New York Association (NYHA), cardiac angioplasty or stenting, myocardial infarction, unstable angina, or other clinically significant cardiac diseases.
Concurrent malignancy or history of prior malignancy requiring systemic treatment. Subjects with a prior history of malignancy whose natural history or treatment does not have the potential to interfere with either the safety or efficacy assessment of the investigational regimen may be included after discussion with Sponsor or designee.
Active acute or chronic graft-versus-host disease (GvHD) other than Grade 1 with skin involvement, or GvHD requiring immunosuppressive treatment within 4 weeks of enrollment.
Any other acute or chronic medical or psychiatric condition that may increase the risk associated with study participation or investigational product administration or that, in the judgment of the investigator, would make the subject inappropriate for entry into the study.
Concurrent opportunistic infections.
History of severe immediate hypersensitivity reaction to any of the agents used in this study, including known hypersensitivity reaction to dimethyl sulfoxide (DMSO) or excipients of cell therapy products.
Any condition that in the opinion of the Investigator might place the subject at unacceptable risk for participation in the study.
Anti-HLA antibodies against all available prula-cel.
For Cohort 1: Subjects with LN
Current or history in the past year of severe central nervous system involvement due to SLE. For subjects who have had seizures, seizure control should be such that no seizures have occurred in at least the past 6 months.
LN pure class V, per 1028 ISN/RPS criteria (Bajema 2018).
Presence of autoimmune disease other than LN as the main diagnosis.
Presence of kidney impairment due to etiologies other than LN.
Treatment with cyclophosphamide, voclosporin, belimumab, or rituximab within 5 half-lives or 2 weeks of enrollment, whichever is shorter.
For Cohort 1: Subjects with SLE with External Involvement
Presence of significant lupus-associated renal disease and/or renal impairment.

Where it is running

Adicet Clinical Trials — Redwood City, California, United States
Roswell Park Comprehensive Cancer Center — Buffalo, New York, United States

Full record on ClinicalTrials.gov

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