NCT06708845
US Zamto-cel Autoimmune Diseases
Recruiting
PHASE1Ages 18+InterventionalTreatmentMiltenyi Biomedicine GmbH
~48 participants
Updated 2026-06-11 on ClinicalTrials.gov
What's tested:zamtocabtagene autoleucelCyclophosphamideFludarabine
At a glance
Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)
Measured over From enrollment through study completion 12 months post zamto-cel infusion
+1 more outcome measured
Conditions
Where it's being run
1 sites across 1 statesWisconsin1
Study leadership
- Esther Eromosele, MD · STUDY_DIRECTOR · Miltenyi Biomedicine
Who to contact
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Do you actually qualify for this trial?
Add a private profile and we'll compare every criterion below against your situation — and tell you which ones are met, uncertain, or excluding.
Eligibility criteria
Inclusion
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:
Lack of response to standard therapy (e.g., failure of ≥ 2 immunosuppressive therapies)
Exclusion
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).
Subjects with neuropsychiatric SLE.
Drug-induced SLE.
"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
What this trial measures
- The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs)From enrollment through study completion 12 months post zamto-cel infusion
- The proportion of subjects with dose-limiting toxicities (DLTs) up to Day 28 and determination of recommended Phase 2 dose (RP2D)From enrollment through Day 28 post zamto-cel infusion