Systemic SclerosisPhase 1NCT06489652
89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis
A Phase 1 study testing 89Zr-Oxine-RY_SW01 Cell Injection in people with Systemic Sclerosis, run by Jiangsu Renocell Biotech Company.
Trial summary
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Sclerosis
- What is being tested?
- 89Zr-Oxine-RY_SW01 Cell Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 30 Jun 2024to 31 May 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntary signing of informed consent;
- Age 18-65 years old (including the threshold), male and female;
- Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for systemic sclerosis (SSc);
- Patients diagnosed with diffuse scleroderma after previous treatment with two or more modalities such as hormones, immunosuppressants, and biologics.
Who cannot join
- Percentage of patient's predicted lung function FVC (forceful lung volume) <50% at screening;
- A previous diagnosis of moderate-to-severe pulmonary hypertension or systolic pulmonary artery pressure >45 mmHg measured by echocardiography at screening;
- The following conditions existed before the screening: (1) myocardial infarction, stroke, renal crisis, severe intestinal disease, severe hypertension (≥160/100mmHg) uncontrolled patients with the onset or exacerbation of clinical symptoms within 6 months; (2) unstable ischemic heart disease, uncontrolled arrhythmia, cardiac arrhythmia, cardiac tachyarrhythmia, and cardiac tachycardia (≥160/100mmHg) uncontrolled patients with the onset or aggravation of clinical symptoms within 3 months. controlled arrhythmia, heart failure, New York Heart Association stage III/IV or echocardiography suggesting left ventricular ejection fraction <50%, renal insufficiency, renal hypertension, etc;
- Patients with pre-screening comorbid autoimmune connective tissue diseases other than systemic sclerosis, but with secondary dry syndrome were allowed to participate in this trial;
- Presence of any of the following laboratory findings at the time of screening:
- ① the presence of abnormal blood routine: hemoglobin <100g / L; white blood cell count <3.0 × 10^9 / L; absolute neutrophil count <1.5 × 10^9 / L; platelet count <100 × 10^9 / L;
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- ② abnormal liver function: ALT or AST >3 times the upper limit of normal (ULN); total bilirubin >3 times the ULN; (iii) Abnormal renal function: estimated glomerular filtration rate (eGFR) <60mL/min/1.73m^2 or any uncontrolled clinically significant laboratory test abnormality judged by the investigator to be likely to affect the interpretation of the study data or the subject's participation in the study;
- Patients with a positive human immunodeficiency virus antibody (anti-HIV-Ab) test, active syphilis, active hepatitis C (hepatitis C antibody positive and HCV-RNA positive), HBsAg positive and HBV-DNA positive during the Screening Period may not be enrolled in the study; and patients with a history of severely active or recurrent bacterial, viral, fungal, parasitic or other infections during the Screening Period ;
- Live/attenuated vaccination within 2 months prior to enrollment;
- Any of the following within 3 months prior to enrollment: (i) major trauma or major surgery (including joint surgery), or major surgery required during the study period, which, in the opinion of the investigator, poses an unacceptable risk to the subject; (ii) treatments such as plasma exchange or extracorporeal light replacement; (iii) subjects participating in any other clinical trial;
- History of any malignancy within 5 years prior to enrollment, except adequately treated or excised basal cell carcinoma of the skin or squamous cell carcinoma of the skin or cervical cancer in situ;
- Intolerance or contraindication to study treatment, including any of the following:
- Hypersensitivity or allergy to any of the components in the excipients of the product; (ii) No peripheral venous access;
- Have plans to have children for at least 2 years after injection administration, or are unwilling to use effective contraception with their partner, or have plans for sperm or egg donation;
- Those who are not suitable for PET/CT, such as those who suffer from claustrophobia;
- Persons who, in the judgment of the investigator, are not suitable for participation in the study.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Phase I Clinical Study of in Vivo Distribution and Metabolic Kinetic Characterization of 89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.
- Conditions
- Systemic Sclerosis
- Being tested
- 89Zr-Oxine-RY_SW01 Cell Injection
- Medical subject headings
- Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
89Zr-Oxine-RY_SW01 Cell InjectionDrug
Also called RY_SW01 Cell Injection
Biodistribution and metabolic kinetic characterization of zirconium-labeled cells in vivo for the treatment of systemic sclerosis by intravenous infusion of 89Zr-Oxine-RY_SW01 cells injection
| Study group | Role | What they receive |
|---|---|---|
| Single-dose group | Experimental | 89Zr-Oxine-RY_SW01 Cell Injection 2.0 x 10^6 cells/kg treatment Receives: Drug: 89Zr-Oxine-RY_SW01 Cell Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine SUV value
Measured: 14day
Fecal SUV value
Measured: 14day
Secondary outcomes (3)
Modified Rodnan Skin Score (mRSS)
Measured: 4、12、24 week
Percentage of FVC projections
Measured: 4、12、24 week
Health Assessment Questionnaire Disability Index (HAQ-DI)
Measured: 4、12、24 week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Jul 2024
- Study start30 Jun 2024 (estimated)
- Primary completion31 May 2025 (estimated)
- Study completion31 May 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic SclerosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Jiangsu Renocell Biotech Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06489652
- Sponsor's protocol ID
- RYSW202402
- Status last verified
- Jun 2024
- First submitted
- 28 Jun 2024
- Last updated
- 8 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of in Vivo Distribution and Metabolic Kinetic Characterization of 89Zr-Oxine-RY_SW01 Cell Injection for the Treatment of Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT06489652
- Acronym / sponsor ID
- RYSW202402
- Conditions
- Systemic Sclerosis
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 8 participants (estimated)
- Lead sponsor
- Jiangsu Renocell Biotech CompanyIndustry (pharma, biotech, devices)
- Study start
- 30 Jun 2024 (estimated)
- Primary completion
- 31 May 2025 (estimated)
- Study completion
- 31 May 2027 (estimated)
- First posted
- 8 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Systemic sclerosis (SSc) tends to progress to involve multiple vital organs within 5 years of diagnosis, significantly impacting patient prognosis and survival. Clinical indications suggest that early intervention is more favorable for long-term outcomes in patients. Although guidelines recommend various drugs for symptomatic treatment, there is currently no standard therapy or effective medication to slow the progression of the disease. Therefore, for patients with diffuse SSc, as defined by a skin score of 10≤mRSS≤30 points, who have been treated with at least two therapies, including steroids, immunosuppressive agents, biologics, etc., within 5 years of diagnosis, the applicant intends to develop a drug that can both modulate the immune system and counteract fibrosis. The goal is to provide long-term benefits to patients through early intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Single-dose group | Experimental | Drug: 89Zr-Oxine-RY_SW01 Cell Injection89Zr-Oxine-RY_SW01 Cell Injection 2.0 x 10^6 cells/kg treatment |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Voluntary signing of informed consent;
- Age 18-65 years old (including the threshold), male and female;
- Diagnosis of SSc according to the 2013 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) diagnostic criteria for systemic sclerosis (SSc);
- Patients diagnosed with diffuse scleroderma after previous treatment with two or more modalities such as hormones, immunosuppressants, and biologics.
Key exclusion criteria (16 listed)
- Percentage of patient's predicted lung function FVC (forceful lung volume) <50% at screening;
- A previous diagnosis of moderate-to-severe pulmonary hypertension or systolic pulmonary artery pressure >45 mmHg measured by echocardiography at screening;
- The following conditions existed before the screening: (1) myocardial infarction, stroke, renal crisis, severe intestinal disease, severe hypertension (≥160/100mmHg) uncontrolled patients with the onset or exacerbation of clinical symptoms within 6 months; (2) unstable ischemic heart disease, uncontrolled arrhythmia, cardiac arrhythmia, cardiac tachyarrhythmia, and cardiac tachycardia (≥160/100mmHg) uncontrolled patients with the onset or aggravation of clinical symptoms within 3 months. controlled arrhythmia, heart failure, New York Heart Association stage III/IV or echocardiography suggesting left ventricular ejection fraction <50%, renal insufficiency, renal hypertension, etc;
- Patients with pre-screening comorbid autoimmune connective tissue diseases other than systemic sclerosis, but with secondary dry syndrome were allowed to participate in this trial;
- Presence of any of the following laboratory findings at the time of screening:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 89Zr-Oxine-RY_SW01 Cell InjectionAlso: RY_SW01 Cell InjectionBiodistribution and metabolic kinetic characterization of zirconium-labeled cells in vivo for the treatment of systemic sclerosis by intravenous infusion of 89Zr-Oxine-RY_SW01 cells injection | Drug | Single-dose group |
Primary outcome
Urine SUV value
Time frame: 14day
Fecal SUV value
Time frame: 14day
3 secondary outcomes
Modified Rodnan Skin Score (mRSS)
Time frame: 4、12、24 week
Percentage of FVC projections
Time frame: 4、12、24 week
Health Assessment Questionnaire Disability Index (HAQ-DI)
Time frame: 4、12、24 week
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing 89Zr-Oxine-RY_SW01 Cell Injection in people with Systemic Sclerosis, run by Jiangsu Renocell Biotech Company.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 8 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ning Wei (15852926678, weining@rybiotech.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine SUV value (time frame: 14day). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jul 2024.