AzTrials
AzTrials

Lupus NephritisPhase 1NCT06375993

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

A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Lupus Nephritis and Autoimmune Diseases, run by Adicet Therapeutics at 2 sites in United States.

Enrolling by invitation

Enrolling by invitation. The study team selects and invites participants, usually from an existing group of patients.

Sites and contacts
Official record
Search all trials

Trial summary

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 Read more about this study

Who is it for?
Ages 18 to 80 years
What is being tested?
ADI-001, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
180 participants
Where
2 sitesUnited States
Study dates
10 Nov 2024to Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 46Show fewer
  • 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.
  • Adequate pulmonary function, defined as Baseline FVC ≥ 45% predicted AND Baseline diffusing capacity of the lung for carbon monoxide (DLCO), corrected for hemoglobin, ≥ 40% predicted.
  • Adequate renal function, defined as Estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 as estimated by the 2021 Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation (Inker 2021).
  • For Cohort 3: Subjects with AAV
  • Diagnosis of AAV defined as either GPA or MPA according to the 2012 Chapel Hill Consensus Conference definitions:
  • Positive for PR3-ANCA or MPO-ANCA
  • Relapsed or refractory AAV:
  • Relapsed following remission after at least 1 standard-of-care immunosuppressive regimen in addition to steroids.
  • Refractory after at least 1 immunosuppressive regimen in addition to steroids administered for at least 3 months.
  • Severe disease (i.e., presence of one or more major AAV sign or symptom per the BVAS or ≥ 3 minor items, or at least the 2 renal items of proteinuria and hematuria due to vasculitis)
  • Adequate renal function: CrCl ≥ 30 mL/min AND Proteinuria ≤ 8 g/24 hour or UPCR ≤ 8 in a spot urine.
  • Adequate pulmonary function defined as saturated oxygen (SpO2) ≥ 93% on room air.
  • For Cohort 4: Subjects with Idiopathic Inflammatory Myopathies
  • Meets the 2017 ACR/EULAR classification criteria (Lundberg 2017) for probable/definite IIM
  • Muscle weakness defined as Manual Muscle Testing (MMT)-8 score < 142/150, and ≥ 2 of the following abnormal core set measures: (i) Patient global assessment VAS ≥ 2 cm (on 10-cm VAS), (ii) Physician global assessment VAS ≥ 2 cm (10-cm VAS), (iii) HAQ-DI > 0.25 , (iv) Extra-muscular global activity VAS ≥ 2 cm (10-cm VAS)
  • Active disease defined as ≥ 1 of the following signs in the past 4 months: a) Elevated serum CK or aldolase levels ≥ 3 times ULN; b) Active myositis by muscle biopsy, muscle MRI, or EMG; c) Active DM rash and CDASI >14; d) Active interstitial lung disease
  • Positivity for ≥ 1 myositis-specific antibody or myositis-associated antibody at screening
  • Inadequate response or intolerance/contraindication to glucocorticoids and to ≥ 2 immunosuppressants for 3 months of an immunosuppressive medication.
  • Adequate renal function defined as estimated glomerular filtration rate ≥ 30 mL/min/1.73 m2 as estimated by the 2021 CKD-EPI equation.
  • For Cohort 4: Subjects with Stiff Person Syndrome
  • Meets the 2009 criteria for diagnosis of stiff person syndrome (SPS) (Dalakas 2009): (a) Stiffness of the axial muscles, particularly the abdominal and thoraco-lumbar paraspinals, leading to hyperlordosis; (b) Superimposed painful spasms triggered by unexpected tactile or auditory stimuli; (c) Severe anxiety with task-specific phobias especially in anticipation of physically challenging tasks; (d) Electromyographic evidence of continuous motor unit activity of agonist and antagonist muscles; (e) Absence of other neurological findings that may suggest an alternative diagnosis; (f) Highly positive anti-GAD titer (> 10,000 IU/mL in serum by ELISA or detectable in CSF)
  • Inadequate response or intolerance or contraindication to ≥ 1 treatment including chronic IVIG or other biologic therapy.

Who cannot join

  • 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.
Show all 52Show fewer
  • 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.
  • Current of history of Class III or IV LN per 2018 ISN/RPS criteria, presently with proteinuria > 1 g/24 h (i.e., UPCR > 1.0 in a spot urine).
  • Pure Class V LN per 2018 ISN/RPS criteria.
  • 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.
  • Treatment with an approved or investigational immunosuppressant for SLE within at least 5 half-lives or 2 weeks of enrollment, whichever is shorter.
  • Presence of autoimmune diseases other than SLE as the main diagnosis.
  • For Cohort 2: Subjects with SSc
  • Treatment with an approved or investigational agent for SSc within at least 5 half-lives or 2 weeks of enrollment, whichever is shorter.
  • ILD requiring supplemental O2 therapy.
  • Evidence of pulmonary arterial hypertension (PAH) as defined as estimated right ventricular systolic pressure (RVSP) of ≥ 45 mmHg or right atrial or ventricular enlargement or dilatation, unless subsequent right heart catheterization shows no PAH.
  • PAH on right heart catheterization requiring specific treatment.
  • Severe gastrointestinal involvement of small and large intestine requiring total parenteral nutrition; active bleeding related to gastric antral vascular ectasia.
  • Renal crisis within 1 year prior to enrollment; presence of kidney impairment due to etiologies other than SSc
  • Active severe central nervous system (CNS) involvement; in case of seizure history, no seizures within the past 6 months prior to enrollment.
  • Presence of systemic autoimmune disease other than SSc.
  • For Cohort 3: Subjects with AAV
  • Clinically significant CNS dysfunction in the opinion of the investigator.
  • Presence of any other known systemic autoimmune disease other than GPA or MPA (subjects with well controlled thyroid disease or type 1 diabetes are eligible for the study)
  • AAV with active diffuse alveolar hemorrhage.
  • AAV with rapid progressive pneumonitis with significant oxygen requirements.
  • Presence of kidney impairment due to etiologies other than AAV.
  • Treatment with an approved or investigational agent for AAV within at least 5 half-lives or 2 weeks of enrollment, whichever is shorter.
  • Solid organ transplant at any time before enrolment.
  • Requires ongoing corticosteroid therapy for AAV on Study Day 0.
  • Required dialysis or plasma exchange within 12 weeks prior to screening.
  • For Cohort 4: Subjects with Autoimmune Muscle Diseases
  • Presence of inclusion body myositis.
  • Presence of myopathy due to malignancy, toxic myopathy, or drug-induced myopathy with the exception of steroid- or statin-induced myopathy.

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

United States2 sites

  • Roswell Park Comprehensive Cancer Center

    Buffalo, New York, 14263

  • Adicet Clinical Trials

    Redwood City, California, 94065

Other trials in United States

About this study

Official title: A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) Anti-CD20 CAR-engineered Allogeneic Gamma-Delta (γδ) T Cells in Adults With Autoimmune Disease

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

Being tested
ADI-001, Fludarabine, Cyclophosphamide
Medical subject headings
Lupus Nephritis, Autoimmune Diseases, Scleroderma, Systemic, Lupus Erythematosus, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Stiff-Person Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT06375993
Study groupRoleWhat they receive
ADI-001 Dose EscalationExperimentalADI-001 is administered via infusion with ascending dose levels as a single dose to determine the maximum tolerated dose (MTD) or maximum assessed dose (MAD) of ADI-001.
Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide
ADI-001 Dose ExtensionExperimentalAfter dose level has been declared safe, additional patients can be enrolled at the declared safe dose to further investigate the safety profile of ADI-001. Dose extension patients will not contribute to the determination of MTD/MAD and DLT evaluation.
Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide
ADI-001 Dose ExpansionExperimentalDose Expansion ADI-001 is administered via infusion at the MTD/MAD to confirm recommended phase 2 dose (Part 2).
Receives: Drug: ADI-001; Drug: Fludarabine; Drug: Cyclophosphamide

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort

    This primary endpoint will be used to determine the Maximum Tolerated Dose (MTD) or Maximum Assessed dose (MAD)

    Measured: 28 Days

  2. Proportion of treatment emergent and treatment related adverse events

    This primary endpoint will be used to determine the MTD/MAD of ADI-001

    Measured: 2 year

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Apr 2024
  2. Study start10 Nov 2024
  3. Primary completionDec 2026 (estimated)
  4. Study completionDec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Sequential
Model description
3+3 Dose Escalation Design
Masking
None (open label)
Enrolment
180 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06375993
Sponsor's protocol ID
ADI-202300103
Status last verified
Mar 2026
First submitted
17 Apr 2024
Last updated
19 Mar 2026
Results posted
No
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing ADI-001, Fludarabine and Cyclophosphamide in people with Lupus Nephritis and Autoimmune Diseases, run by Adicet Therapeutics at 2 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 46 inclusion and 52 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: enrolling by invitation, as of the sponsor's last update on 19 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Incidence of Subjects with Dose Limiting Toxicities within each dose level cohort (time frame: 28 Days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06375993.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2026.

AzTrials uses cookies for analytics and advertising. You can accept or reject them; the site works either way. Privacy Policy.

Free account

Log in to keep searching

You’ve used your 3 free searches. AzTrials is free: log in or create a free account to keep searching clinical trials and save the ones you want to follow.

Create a free accountLog in