CAR-T therapy takes on lupus and scleroderma in early trial
NCT ID NCT06708845
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This early-phase trial is testing a new treatment called zamto-cel, a CAR-T cell therapy, for people with severe lupus or scleroderma that hasn't improved with standard treatments. The study will enroll 48 participants and primarily look at safety and side effects. Participants first receive chemotherapy to prepare their bodies, then the modified immune cells are given as a one-time infusion.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- zamtocabtagene autoleucel (zamto-cel), a CAR-T cell therapy, given after chemotherapy
- What this could lead to
- If it works, this could point toward a new treatment option for people with severe autoimmune diseases that haven't responded to standard therapies.
- What could go wrong
- This is a very early (Phase 1) and small (48 people) trial focused on safety, not yet on effectiveness. CAR-T therapy can cause serious side effects like cytokine release syndrome.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1
The first testing in people. Mainly checks safety and dose, usually in a small group.
- Participants
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About 48 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jul 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
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Study contacts
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Contact
Email: •••••@•••••
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Contact
Email: •••••@•••••
Locations
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Froedtert Hospital and the Medical College of Wisconsin
RECRUITINGMilwaukee, Wisconsin, 53226, United States
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