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New treatment option for Lupus Nephritis
Official title US Zamto-cel Autoimmune Diseases
ClinicalTrials.gov ID: NCT06708845
What this study is testing
What is zamtocabtagene autoleucel?
zamtocabtagene autoleucel is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for lupus nephritis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
- Time commitment: about 1 year
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- General Key Inclusion/
You likely can't join if
- 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
See the full eligibility criteria
- General Key Inclusion/
- 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...
- people 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Milwaukee, Wisconsin, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 1 year per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Milwaukee, Wisconsin, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.