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US Zamto-cel Autoimmune Diseases

RecruitingPhase 1Ages 18 Years - anyAllMiltenyi Biomedicine GmbH
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
General Key Inclusion/Exclusion Criteria Across All Cohorts Inclusion Criteria: •Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc) Exclusion Criteria: * Prior gene therapy treatment * Active malignancy within past 5 years * Significant active fungal or bacterial infection * History or presence of CNS lupus or other CNS disease * 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 Inclusion Criteria: * 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 Exclusion Criteria: * Subjects with neuropsychiatric SLE. * Drug-induced SLE. Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria Inclusion Criteria: * 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) 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. Systemic Sclerosis/Diffuse Cutaneous Systemic Sclerosis Cohort Key Inclusion/ Exclusion Criteria Inclusion Criteria: * 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 Criteria: * "Active" gastric antral vascular ectasia, as evidenced by bleeding (ie, on esophagogastroduodenoscopy) in the past 6 months or as per Investigator's assessment. * History of SSc renal crisis within 1 year prior to Screening; presence of kidney impairment due to conditions other than SSc
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What it tests

  • zamtocabtagene autoleucel
  • Cyclophosphamide
  • Fludarabine
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Where

1 site
Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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