Phase 1 Lupus Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
For everyone in the trial:
- You have been diagnosed with one of the following conditions: Systemic Lupus Erythematosus without kidney involvement (SLE-Non-renal), Lupus with kidney involvement (Lupus Nephritis), or Systemic Sclerosis/Diffuse Cutaneous Systemic Sclerosis
If you have Lupus (without kidney involvement):
- A specific blood test at screening shows certain lupus-related antibodies (anti-double stranded DNA or anti-Smith)
- Your lupus is considered active based on standard disease activity scoring tools used by doctors
- Your lupus has not responded well enough to steroids and at least 2 other treatments (such as cyclophosphamide, mycophenolic acid, belimumab, azathioprine, anifrolumab, methotrexate, rituximab, or obinutuzumab), each taken for at least 3 months
If you have Lupus with kidney involvement (Lupus Nephritis):
- A specific blood test at screening shows certain lupus-related antibodies (anti-double stranded DNA or anti-Smith)
- A kidney biopsy (taken during screening or within the past 6 months) has confirmed active lupus nephritis
- Your condition is continuing to worsen despite being on the highest tolerated doses of certain blood pressure/kidney-protecting medications (unless you are unable to take them due to allergy or intolerance)
- Your condition has not responded well enough to steroids, hydroxychloroquine, and at least 1 other treatment (such as cyclophosphamide, mycophenolic acid derivatives, belimumab, azathioprine, methotrexate, rituximab, obinutuzumab, or certain immune-suppressing medicines), each taken for at least 3 months
If you have Systemic Sclerosis:
- You have active skin thickening (scored at 16 or above on a standard scale) within the past 6 months, along with signs of worsening skin disease in new or existing areas of the body, OR you have progressive lung scarring (worsening breathing symptoms confirmed by a special type of lung scan)
- Your condition has not responded to at least 2 immune-suppressing treatments
Who may not be able to join:
For everyone in the trial:
- You have previously received gene therapy
- You have had a cancer diagnosis in the past 5 years
- You currently have a significant active fungal or bacterial infection
- You have a history of, or currently have, lupus or another disease affecting the brain or nervous system
- Your kidney function is below a certain level (confirm with trial site)
- Your liver function blood test result (total bilirubin) is outside the normal range, unless you have a confirmed inherited condition that causes this, such as Gilbert syndrome
If you have Lupus (without kidney involvement):
- You have a form of lupus that affects the brain or mental health (neuropsychiatric SLE)
- Your lupus was caused by a medication (drug-induced SLE)
If you have Lupus with kidney involvement (Lupus Nephritis):
- Your kidney function has been deteriorating very rapidly, with creatinine levels doubling within 3 months before joining the trial, or as assessed by the study doctor
If you have Systemic Sclerosis:
- You have had active bleeding from fragile blood vessels in the stomach in the past 6 months, or as assessed by the study doctor
- You have had a serious kidney crisis related to Systemic Sclerosis within the past year, or you have kidney problems caused by something other than Systemic Sclerosis
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Esther Eromosele, MD, Miltenyi Biomedicine
Phone: 617-218-0044
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
The incidence and severity of adverse events (AEs), adverse events of special interest (AESIs), and serious adverse events (SAEs); The proportion of subjects with dose-limiting toxicities (DLTs) up to Day 28 and determination of recommended Phase 2 dose (RP2D)
Can't join this trial?
Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.