Tests a cell therapy in adults with lupus or systemic sclerosis

Trial details

Who runs it

Miltenyi Biomedicine GmbH

Trial code

NCT06708845

Record updated

11 June 2026

Original description

AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.Read full original descriptionShow less

A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases

AID is a phase I multi-cohort study to assess the safety and tolerability of zamtocabtagene autoleucel (zamto-cel) in patients with refractory autoimmune diseases (SLE-Non renal, SLE-LN, SSc/dcSSc) after receiving standard therapy.

Inclusion: •Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc); Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith; Systemic Lupus Erythematosus Disease Activity Index-2000 score ≥ 8 AND at least 1 British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) organ scores; Inadequate response to glucocorticoids and to at least 2 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid or its derivatives, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab; Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith; Confirmed LN diagnosis by kidney biopsy during screening or within the previous 6 months, with severe active phase of the disease; Progressing despite maintenance on maximally tolerated doses of renin- angiotensin system (RAS) blocking agents, unless allergic to or intolerant of ACE inhibitors and ARBs; Inadequate response to glucocorticoids and hydroxychloroquine and at least 1 of the following treatments, used for at least 3 months each: cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, calcineurin inhibitor (cyclosporin, tacrolimus or voclosporin); Active disease defined as:; Modified Rodnan skin score (mRSS) ≥ 16 units, in the prior 6 months, with 1 or more of the following:; Increase in mRSS by ≥ 3 units or 10%; Involvement of 1 new body area with increase in mRSS by ≥ 2 units; Involvement of 2 new body areas with increase by ≥ 1 mRSS unit OR; Progressive interstitial lung disease (ILD) defined as:; Worsening of respiratory symptoms and an increased extent of fibrosis evaluated by high-resolution computed tomography; Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies).

Exclusion: Prior gene therapy treatment; Drug-induced SLE; Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria; History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc; Active malignancy within past 5 years; Significant active fungal or bacterial infection; History or presence of CNS lupus or other CNS disease; "Active" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment; eGFR < 45 mL/min/1.73 m\^2; Total bilirubin outside the normal range (unless congenital hyperbilirubinemia such as Gilbert syndrome has been confirmed); Systemic Lupus Erythematosus-Non-renal Key Inclusion/Exclusion Criteria; •Evidence of Rapidly progressive glomerulonephritis (defined as a doubling of serum creatinine within 3 months prior to enrollment) or as determined by the study investigator; Subjects with neuropsychiatric SLE; Systemic Sclerosis/Diffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion/ Exclusion Criteria.

General Key Inclusion/Exclusion Criteria Across All Cohorts.

ClinicalTrials.gov NCT06708845