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Updated June 2026 · ClinicalTrials.gov

RECRUITINGPhase 1INTERVENTIONAL

US Zamto-cel Autoimmune Diseases

A Phase I Multicohort Trial of Zamtocabtagene Autoleucel (Zamto-Cel) in Subjects With Severe Refractory Autoimmune Diseases

US Zamto-cel Autoimmune Diseases (NCT06708845) is a Phase 1 interventional studying Lupus Nephritis and Systemic Lupus Erythematosus, sponsored by Miltenyi Biomedicine GmbH. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 1 trials test a new treatment for the first time in humans, focusing on safety, dosing, and how the body processes the drug. For Lupus Nephritis, a Phase 1 study typically enrolls a small number of participants — often healthy volunteers or patients who have exhausted standard treatment options. Phase 1 results determine whether a treatment moves into larger Phase 2 efficacy studies.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

With a target enrollment of 48 participants, this is a small study — typical of early-phase research, rare-disease trials, or pilot studies designed to generate preliminary signal before a larger study is launched.

Who May Be Eligible (Plain English)

General Key Inclusion/Exclusion Criteria Across All Cohorts Who May Qualify: •Confirmed diagnosis of autoimmune conditions (where your immune system attacks your own body) (SLE-Non-renal, SLE-LN, SSc/ dcSSc) Who Should NOT Join This Trial: - 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 Who May Qualify: - 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 Who Should NOT Join This Trial: - Subjects with neuropsychiatric SLE. - Drug-induced SLE. Systemic Lupus Erythematosus - Lupus Nephritis Key Inclusion/Exclusion Criteria Who May Qualify: - 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
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

Treatments Being Tested

BIOLOGICAL

zamtocabtagene autoleucel

chimeric antigen receptor T-cell (CAR-T) therapy

DRUG

Cyclophosphamide

Lymphodepleting chemotherapy

DRUG

Fludarabine

Lymphodepleting chemotherapy

Locations (1)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

Froedtert Hospital and the Medical College of Wisconsin
Milwaukee, Wisconsin, United States

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT06708845), the sponsor (Miltenyi Biomedicine GmbH), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT06708845 clinical trial studying?

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. The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT06708845?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT06708845?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT06708845. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT06708845. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-06-26 · Data from ClinicalTrials.gov.