Clinical trial for Lupus Nephritis
Official title US Zamto-cel Autoimmune Diseases
ClinicalTrials.gov ID: NCT06708845
What this study is testing
What is zamtocabtagene autoleucel?
an investigational CAR‑T cell therapy being studied as a potential treatment for lupus nephritis and other refractory autoimmune diseases is designed to engineer a patient’s own T cells to express receptors that recognize CD19 and CD20 antigens, aiming to eliminate the cells that drive autoimmunity
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
- The study aims to find out if zamto-cel is safe and well‑tolerated in people whose autoimmune disease has not responded to standard treatments.
- Who it's for
- Adults with refractory systemic lupus erythematosus (non‑renal or kidney involvement) or systemic sclerosis (diffuse cutaneous).
- What's involved
- Participants will receive the investigational zamto-cel infusion and undergo regular check‑ups, lab tests, and safety monitoring.
- 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
- 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
- Positive for at least 1 of the following autoantibodies at Screening: anti- double stranded DNA or anti-Smith
See the full eligibility criteria
- General Key Inclusion/
- 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
- 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
- people with neuropsychiatric SLE.
- 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
- 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
- "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 is enrolling
- 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, but 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?
This study is enrolling now at Milwaukee, Wisconsin, United States. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.