US Zamto-cel Autoimmune Diseases
Recruiting now · Phase 1
Conditions studied: Lupus Nephritis, Systemic Lupus Erythematosus, Systemic Sclerosis (SSc), Diffuse Cutaneous Systemic Sclerosis
In brief
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.
Key facts
- Study ID
- NCT06708845
- Run by
- Miltenyi Biomedicine GmbH
- People needed
- 48
- Starts
- 2026-07-01
- Expected to finish
- 2028-07-01
- Last updated by the study team
- 2026-06-11
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- Confirmed diagnosis of autoimmune disease (SLE-Non-renal, SLE-LN, SSc/ dcSSc)
You may not qualify if…
- 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:
Where it is running
- Froedtert Hospital and the Medical College of Wisconsin — Milwaukee, Wisconsin, United States (enrolling)
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.