New shot aims to tame rare autoimmune disease
NCT ID NCT07641634
First seen Jun 27, 2026 · Last updated Sep 09, 2026 · Updated 2 times
Summary
This early-phase trial tests a new drug called PRO-203, given as a single shot under the skin. First, healthy volunteers will check safety; then, people with systemic sclerosis (a rare autoimmune disease that hardens skin and organs) will receive the drug. The main goal is to see if it's safe and how it affects immune cells.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- PRO-203 (a drug given as a shot under the skin)
- What this could lead to
- If it works, this could point toward a treatment that controls systemic sclerosis by targeting immune cells.
- What could go wrong
- This is a very early, small trial (44 people) focused on safety, not effectiveness. It may fail to show benefit or have side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
-
Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
-
About 44 people
The number the study aims to enrol. It can still change while the study runs.
- Started
-
Oct 2025
- Expected to finish
-
Jan 2028
An estimate. End dates often move.
- Lead sponsor
-
A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
-
18 to 65 years
- Sex
-
Anyone
- Healthy volunteers
-
Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Key Inclusion Criteria (All Participants) * Is male or female, age 18 to 65 years, inclusive, at Screening. * Able to provide Informed Consent. * Absolute B cell count \> 25 cells/uL. Additional Inclusion for Part 1 (Closed to Enrollment) * In good general health, determined by no clinically significant findings in the of the investigator from medical history, physical examination, 12-lead ECG, clinical laboratory findings, and vital signs at Screening and Day -1 (participants with Gilbert's disease with associated abnormalities of liver function tests are eligible for enrollment). * Up to date vaccination status per local guidelines (including but not limited to influenza vaccine, COVID booster and hepatitis B vaccine). Additional Inclusion for Part 2 * Fulfill 2013 ACR/ EULAR criteria for classification of SSc with a total score of ≥ 9. * Active disease defined as at least two of the following at screening: * Disease duration ≤ 2 years (since onset of first-non-Raynaud-symptom), or * Elevated acute phase reactant levels (CRP ≥ 6 mg/L, erythrocytes sedimentation rate \[ESR\] ≥ 28 mm/1h, or platelet count ≥ 330,000/µL), or * Baseline mRSS ≥10 with evidence of progression, defined as mRSS increase at least 3 units, or involvement of 1 new body area and mRSS increase at least 2 units, or involvement of 2 new body areas (each within the previous 6 months), or * ≥ 1 tendon friction rub, or * Elevation of CK or aldolase \> 2 × the upper limit of normal (ULN) consistent with SSc-related myopathy, or * Progressive fibrosing interstitial lung disease (ILD) as defined by at least one of the following criteria at any time within the prior 2 years: 1. relative decline in forced vital capacity (FVC) % predicted ≥ 10%, or 2. relative decline in FVC % predicted ≥ 5% to \<10% and worsened respiratory symptoms, or 3. relative decline in FVC % predicted ≥ 5% to \<10% and increased extent of fibrosis on high-resolution computed tomography (HRCT), or 4. worsened respiratory symptoms and increased extent of fibrosis on HRCT * Intolerant or refractory to at least 1 line of standard therapy, including methotrexate, azathioprine, IVIG, mycophenolic acid derivatives, cyclophosphamide, TNF-inhibitors, rituximab, or tocilizumab. Key Exclusion Criteria (All Participants) * Any clinically significant underlying illness in the opinion of the investigator. * Active infection within 4 weeks prior to screening. Participants receiving IV antibiotics or having received IV antibiotics within 14 days prior to enrollment are excluded. * Positive QuantiFERON-Gold TB test at screening. * Plan to receive live, attenuated vaccine after signing ICF (inactive vaccines, such as the flu vaccine, are allowed). * Evidence of malignant disease or malignancies diagnosed within the previous 5 years (except for treated local basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix uteri that had been excised and cured). * Currently enrolled in another investigational device or drug study, or less than 30 days or 5 half-lives of the prior investigational agent (whichever is longer) have passed since ending another investigational device or drug study or plans to enroll in another investigational device or drug study during the course of this study. * Social smokers e.g. up to 10 cigarettes per week (or equivalent amounts of nicotine containing products) and willing to abstain during inpatient stay, are allowed Additional Exclusion Criteria for Part 1 (Closed to Enrollment) * Use of any prescription medication within 14 days and OTC medications, vitamins, herbal medications (e.g., St. John's wort), or cannabis, except for contraceptive medications and as needed (prn) acetaminophen/paracetamol (not exceeding 2 grams/day) within 7 days prior to administration of the study drug and throughout the study. Additional Exclusion Criteria for Part 2 * Rheumatic autoimmune disease other than SSc. * Positive anti-centromere antibodies. * Pulmonary disease with FVC ≤ 45% of predicted, or DLCO ≤ 35% of predicted. * Class 2 or higher pulmonary arterial hypertension or evidence of other moderately severe pulmonary disease. * Renal crisis within 6 months prior to Screening. * Prior treatment with cellular immunotherapy (eg, CAR-T) or gene therapy product directed at any target. * Previous treatment with chlorambucil, bone marrow transplantation, or total lymphoid irradiation. * Previous treatment with thalidomide, anti-thymocyte globulin, plasmapheresis, or extracorporeal photopheresis. * Unable to washout current immunosuppressive therapy within 2 months * Has received anti-CD19 or CD20 therapies, within 6 months prior to start of therapy * Plan to receive live or live-attenuated vaccines within 8 weeks prior to first dose of study drug and during treatment until B cell reconstitution to 80% of baseline (inactive vaccines, such as the flu vaccine, are allowed)
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for Healthy volunteers are added.
Genom att skicka in godkänner du våra Användarvillkor
Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
-
The study's own enquiry address
This study publishes an address for enquiries. See it below .
-
The places running it
10 sites in 3 countries. The list below names each one and where it is.
-
The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
-
A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Show contact details
Enter your email to view the contact information for this study.
Genom att skicka in godkänner du våra Användarvillkor
Study contacts
-
Contact
Email: •••••@•••••
Locations
-
Guangdong Provincial People's Hospital
RECRUITINGGuangzhou, China
Contact Email: •••••@•••••
-
Hospital Angeles Chihuahua
RECRUITINGChihuahua City, Mexico
Contact Email: •••••@•••••
-
Nanjing Drum Tower Hospital
RECRUITINGNanjing, China
Contact Email: •••••@•••••
-
Nucleus Network
COMPLETEDMelbourne, Victoria, 3004, Australia
-
Peking University Third Hospital
RECRUITINGBeijing, China
Contact Email: •••••@•••••
-
Pingxiang People's Hospital
RECRUITINGPingxiang, China
Contact Email: •••••@•••••
-
Seoul National University Hospital
RECRUITINGSeoul, South Korea
Contact Email: •••••@•••••
-
The First Affiliated Hospital of Nanchang University
RECRUITINGNanchang, China
Contact Email: •••••@•••••
-
The Second Affiliated Hospital of Nanchang University
RECRUITINGNanchang, China
Contact Email: •••••@•••••
-
The Third Affiliated Hospital of Sun Yat-Sen University
RECRUITINGGuangzhou, China
Contact Email: •••••@•••••
-
Unidad Médica para la Salud Integral (UMSI)
RECRUITINGSan Nicolás de los Garza, Mexico
Contact Email: •••••@•••••
More trials for these conditions
Other studies related to the condition(s) this trial covers.
- Scientists probe the nerve highways behind strength gains
- New syphilis test kits put to the test with donated blood
- Can a copy of a blockbuster arthritis drug match the original? scientists test it in healthy people
- Novo nordisk tests Brand-New molecule in humans for the first time
- New sedative candidate goes Head-to-Head with propofol in early human test
- Can a Room-Temperature dairy drink build muscle?