Phase 2 Lupus Trial, Recruiting

Written by an AI model from ClinicalTrials.gov eligibility criteria and checked on a sample basis. Please confirm against the original criteria.

Who might be able to join this trial:

For people with Systemic Sclerosis (SSc / Scleroderma):

• People who have been formally diagnosed with SSc according to established medical classification criteria, with a positive ANA blood test at a certain level
• People with the "diffuse" form of SSc whose disease started within the last 7 years and who have a significant level of skin involvement (measured by a standard scoring system), OR people with diffuse or limited SSc who also have lung scarring (ILD) shown on a special type of CT scan, with disease starting within the last 7 years, and either signs that the lung disease is getting worse or lung function/scan results below a certain threshold
• People whose SSc has not responded well enough to at least one of the following treatments used for at least 3 months: mycophenolate, cyclophosphamide, rituximab, or tocilizumab

For people with Systemic Lupus Erythematosus (SLE):

• People formally diagnosed with SLE according to established 2019 criteria, with a positive ANA or anti-dsDNA blood test at a certain level
• People with lupus-related kidney disease (lupus nephritis) confirmed by a kidney biopsy taken within the past year, showing a specific level of kidney involvement (class III or IV, with or without class V)
• People with lupus nephritis who still have significant protein in their urine despite receiving standard treatments for at least 12 weeks, and who have tried and not responded to at least 2 standard immune-suppressing treatments for 3 months
• People with SLE but without kidney involvement who have a sufficiently high disease activity score and who have tried and not responded to at least 2 standard immune-suppressing treatments for 3 months (or could not tolerate them, or were unable to obtain them)
• People currently taking certain blood pressure or kidney-protective medications (such as ACE inhibitors or SGLT2 inhibitors) who have been on a stable dose for at least 8 weeks before the screening visit
• People taking oral steroids at a dose below a certain level at the time of joining

For people with Chronic Graft-versus-Host Disease (chronic GVHD):

• People who have chronic GVHD that has not responded adequately to high-dose steroid treatment, or who cannot tolerate steroids or have had serious complications from them
• People whose chronic GVHD symptoms are rated as moderate to severe using a standard medical scoring system
• People whose chronic GVHD has not responded adequately to both ruxolitinib and belumosudil, or who could not tolerate these treatments
• People who may be taking low-dose steroids for adrenal replacement purposes

For everyone (all three conditions):

• People aged 18 to 80 years who are able to give informed consent
• People whose blood cell counts, liver function, kidney function, heart function, and oxygen levels meet certain minimum thresholds (the trial site will assess these through testing)
• People who have recovered sufficiently from any side effects of previous treatments
• Women who could become pregnant must have a negative pregnancy test before joining
• All participants who could father or carry a child must use effective contraception throughout the study and for 3 months after treatment ends, and must notify their doctor immediately if pregnancy occurs or is suspected
• People who are willing and able to attend all required study visits and follow the study procedures

Who may not be able to join:

SSc-specific:

• People with SSc-related high blood pressure in the lungs (pulmonary arterial hypertension) that currently requires active treatment
• People with severe, rapidly worsening SSc-related bowel disease requiring feeding through a drip (parenteral nutrition), or a specific stomach blood vessel condition (gastric antral vascular ectasia)
• People who have previously had a kidney crisis related to their SSc (scleroderma renal crisis)
• People with severely reduced lung function below certain thresholds, or blood oxygen levels below 92% at rest without extra oxygen

SLE-specific:

• People with lupus nephritis whose kidney biopsy shows a high level of permanent kidney scarring or damage
• People with a biopsy-confirmed kidney disease other than active lupus nephritis
• People with severely reduced lung function below certain thresholds, or blood oxygen levels below 92% at rest without extra oxygen
• People with serious active heart complications related to SLE, such as certain types of inflammation around or of the heart

Chronic GVHD-specific:

• People who have taken immune-suppressing medications (other than steroids) within a certain timeframe before the start of treatment — the required gap depends on the specific medication (confirm with trial site)
• People currently receiving immune-suppressing medications for a reason other than managing their chronic GVHD
• People on steroid doses above a certain level at the time of joining or at the time of the pre-treatment chemotherapy
• People who have received rituximab within 6 months before the pre-treatment chemotherapy phase

For everyone (all three conditions):

• People with uncontrolled medical, psychological, or other personal circumstances that would make it difficult to follow the study requirements, as assessed by the medical team
• People with active, significant disease affecting the brain or central nervous system
• People with a prior or current history of cancer or certain blood cell disorders (some exceptions may apply — confirm with trial site)
• People with active hepatitis C, active syphilis, HIV, or certain other viral infections
• People with an uncontrolled serious infection at the time of screening or close to the start of treatment
• People who have had a serious heart event within the 6 months before screening, such as a heart attack, severe heart failure, or unstable chest pain
• People who have previously received CAR T cell therapy or other genetically modified T cell therapy
• People who have recently received certain immune-suppressing medications within specific timeframes before the treatment phase begins (the required gap varies by medication — confirm with trial site)
• People who have taken mycophenolate mofetil within 4 days before the pre-treatment chemotherapy phase begins (some exceptions may apply — confirm with trial site)
• People with a history of a severe allergic reaction to fludarabine, cyclophosphamide, tafasitamab, or their breakdown products
• People with severe, uncontrolled disease affecting multiple organ systems, including serious or uncontrolled infections
• People with other medical conditions that the trial doctors believe could put them at unacceptable risk or interfere with the study

Important: Always verify eligibility with the trial site directly before applying.