NCT06708845 US Zamto-cel Autoimmune Diseases
| NCT ID | NCT06708845 |
| Status | Recruiting |
| Phase | Phase 1 |
| Sponsor | Miltenyi Biomedicine GmbH |
| Condition | Lupus Nephritis |
| Study Type | INTERVENTIONAL |
| Enrollment | 48 participants |
| Start Date | 2026-07 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 48 participants in total. It began in 2026-07 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Esther Eromosele, MD
STUDY DIRECTOR
Miltenyi Biomedicine
Frequently Asked Questions
Who can join the NCT06708845 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Lupus Nephritis. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06708845 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06708845 currently recruiting?
Yes, NCT06708845 is actively recruiting participants. Contact the research team at clinicaltrials@miltenyi.com for enrollment information.
Where is the NCT06708845 trial being conducted?
This trial is being conducted at Milwaukee, United States.
Who is sponsoring the NCT06708845 clinical trial?
NCT06708845 is sponsored by Miltenyi Biomedicine GmbH. The principal investigator is Esther Eromosele, MD at Miltenyi Biomedicine. The trial plans to enroll 48 participants.
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