Autoimmune DiseasesEarly Phase 1NCT07362758
Exploratory Study on mRNA Therapy Targeting CD19 for the Treatment of Refractory Autoimmune Diseases
A Early Phase 1 study testing in vivo CAR-T drug based on LNP-mRNA in people with Autoimmune Diseases, run by Xinqiao Hospital of Chongqing.
Trial summary
Autoimmune diseases, such as immune thrombocytopenia (ITP), immune hemolytic anemia (AIHA), systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathy (IIM), ulcerative colitis (UC), and systemic sclerosis (SSc), are a type of chronic disabling disease characterized by the immune system… Read more about this study
- Who is it for?
- Ages 14 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- in vivo CAR-T drug based on LNP-mRNA
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 47 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2026to 31 Dec 2028
- Phase
- Early 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 14 to 70 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 1. Age range of 14-70 years old (including threshold), gender not limited;
- 2. KPS score>60 points, life expectancy greater than 6 months;
- 3. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
- 4. Those who can understand this experiment and have signed the informed consent form.
- 5. Before screening (at baseline), corresponding conditions should be met;
- 6. Indications for severe, recurrent, or refractory immune related diseases, including immune thrombocytopenia (ITP), autoimmune hemolytic anemia (AIHA), systemic lupus erythematosus（SLE），systemic sclerosis （SSc） etc., meet the corresponding inclusion criteria; For other types of diseases, researchers will assess whether they meet the inclusion requirements after fully evaluating the risks and benefits based on the patient's treatment needs.
Who cannot join
- 1) Study participants who are allergic or hypersensitive to any component of the investigational drug, including those who are allergic to messenger RNA (mRNA) vaccines or other RNA LNP products.
- 2) Merge any active infections that require antibiotic treatment and have not been controlled for at least one week prior to D1 administration.
- 3) Malignant tumors diagnosed within the first 2 years of screening are excluded, except for skin basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ that has been adequately treated.
- 4) Uncontrolled ischemic heart disease, including unstable angina within the previous 6 months of screening, or evidence of active ischemic heart disease on electrocardiogram.
- 5) New York Heart Association (NYHA) grade III-IV heart failure.
- 6) Study participants with combined active hepatitis B virus (HBV) infection [defined as surface antigen (HBsAg) positive and HBV DNA positive (detected by PCR)].
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- 7) Study participants with combined active hepatitis C virus (HCV) infection (defined as HCV RNA positive (detected by PCR), regardless of anti HCV antibody status).
- 8) Human immunodeficiency virus (HIV) infection or history of HIV infection.
- 9) Study participants who tested positive for Treponema pallidum specific antibodies.
- 10) There may be active infection of Mycobacterium tuberculosis.
- 11) Women who are currently pregnant, breastfeeding, or planning to become pregnant.
- 12) Combining severe or recently (<2 months) diagnosed medical conditions, as determined by the researchers, may affect the study participants' tolerance to the study drug or their ability to complete the study process.
- 13) Received attenuated live vaccine or protein subunit vaccine within 30 days prior to the first study medication.
About this study
Autoimmune diseases, such as immune thrombocytopenia (ITP), immune hemolytic anemia (AIHA), systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathy (IIM), ulcerative colitis (UC), and systemic sclerosis (SSc), are a type of chronic disabling disease characterized by the immune system mistakenly attacking the body itself, leading to tissue damage and organ dysfunction.Autoimmune hematological diseases, especially difficult to treat autoimmune diseases, are a type of disease that is difficult to treat and has a significant impact on patients' lives. Although there are various treatment methods currently available, there are still many limitations to autoimmune sexually transmitted diseases that aim for long-term remission, and further research and breakthroughs are urgently needed.
The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.
The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
- Conditions
- Autoimmune Diseases
- Being tested
- in vivo CAR-T drug based on LNP-mRNA
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
in vivo CAR-T drug based on LNP-mRNADrug
in vivo CAR-T drug based on LNP-mRNA
| Study group | Role | What they receive |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA, Escalation dose | Experimental | Not described Receives: Drug: in vivo CAR-T drug based on LNP-mRNA |
| in vivo CAR-T drug based on LNP-mRNA, Extended dose | Experimental | Not described Receives: Drug: in vivo CAR-T drug based on LNP-mRNA |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence of dose limiting toxicity (DLT)
Measured: Within 28 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Measured: Through study completion, an average of 2 years
Secondary outcomes (2)
Efficacy evaluation: degree of disease remission
Measured: Within 24 weeks after the initial treatment
Pharmacodynamic characteristics: B cell clearance rate
Measured: Within at least 28 days after the initial treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jan 2026
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2028 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 47 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Xinqiao Hospital of Chongqing
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Xi Zhang, MD, Xinqiao Hospital of Chongqing
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07362758
- Sponsor's protocol ID
- CD19 for Autoimmune diseases
- Status last verified
- Jan 2026
- First submitted
- 2 Jan 2026
- Last updated
- 23 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploratory Study on mRNA Therapy Targeting CD19 for the Treatment of Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07362758
- Acronym / sponsor ID
- CD19 for Autoimmune diseases
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 47 participants (estimated)
- Lead sponsor
- Xinqiao Hospital of ChongqingUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2028 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 23 Jan 2026 (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.
Autoimmune diseases, such as immune thrombocytopenia (ITP), immune hemolytic anemia (AIHA), systemic lupus erythematosus (SLE), lupus nephritis (LN), idiopathic inflammatory myopathy (IIM), ulcerative colitis (UC), and systemic sclerosis (SSc), are a type of chronic disabling disease characterized by the immune system mistakenly attacking the body itself, leading to tissue damage and organ dysfunction.Autoimmune hematological diseases, especially difficult to treat autoimmune diseases, are a type of disease that is difficult to treat and has a significant impact on patients' lives. Although there are various treatment methods currently available, there are still many limitations to autoimmune sexually transmitted diseases that aim for long-term remission, and further research and breakthroughs are urgently needed.
The advent of COVID-19 vaccine has brought LNP mRNA technology into the public's view. After years of development, it not only shines brilliantly in COVID-19 vaccine, but also is widely used in the treatment and exploration of cancer, rare diseases and other fields. Lipid nanoparticles (LNP) are currently the most mature non viral delivery platform, capable of protecting mRNA from nuclease degradation, promoting intracellular uptake, and achieving efficient translation in vivo.
The core of LNP-mRNA technology targeting CD19 is to encapsulate the mRNA encoding specific proteins (such as anti-CD19 related proteins) in lipid nanoparticles and deliver them to the body through intravenous or intramuscular injection.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNA, Escalation dose | Experimental | Drug: in vivo CAR-T drug based on LNP-mRNA |
| in vivo CAR-T drug based on LNP-mRNA, Extended dose | Experimental | Drug: in vivo CAR-T drug based on LNP-mRNA |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 1. Age range of 14-70 years old (including threshold), gender not limited;
- 2. KPS score>60 points, life expectancy greater than 6 months;
- 3. Male and female patients of appropriate age must use reliable methods of contraception before entering the trial, during the research process until 30 days after discontinuation of medication; Reliable contraceptive methods will be determined by the primary researchers or designated personnel;
- 4. Those who can understand this experiment and have signed the informed consent form.
- 5. Before screening (at baseline), corresponding conditions should be met;
Key exclusion criteria (13 listed)
- 1) Study participants who are allergic or hypersensitive to any component of the investigational drug, including those who are allergic to messenger RNA (mRNA) vaccines or other RNA LNP products.
- 2) Merge any active infections that require antibiotic treatment and have not been controlled for at least one week prior to D1 administration.
- 3) Malignant tumors diagnosed within the first 2 years of screening are excluded, except for skin basal cell carcinoma, squamous cell carcinoma, or cervical cancer in situ that has been adequately treated.
- 4) Uncontrolled ischemic heart disease, including unstable angina within the previous 6 months of screening, or evidence of active ischemic heart disease on electrocardiogram.
- 5) New York Heart Association (NYHA) grade III-IV heart failure.
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 |
|---|---|---|
| in vivo CAR-T drug based on LNP-mRNAin vivo CAR-T drug based on LNP-mRNA | Drug | in vivo CAR-T drug based on LNP-mRNA, Escalation dose, in vivo CAR-T drug based on LNP-mRNA, Extended dose |
Primary outcome
The incidence of dose limiting toxicity (DLT)
Time frame: Within 28 days after the initial treatment
Maximum tolerated dose (MTD) or optimal biological dose (OBD)
Time frame: Through study completion, an average of 2 years
2 secondary outcomes
Efficacy evaluation: degree of disease remission
Time frame: Within 24 weeks after the initial treatment
Pharmacodynamic characteristics: B cell clearance rate
Time frame: Within at least 28 days after the initial treatment
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 23 Jan 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing in vivo CAR-T drug based on LNP-mRNA in people with Autoimmune Diseases, run by Xinqiao Hospital of Chongqing.
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 6 inclusion and 13 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 23 Jan 2026. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of dose limiting toxicity (DLT) (time frame: Within 28 days after the initial treatment). 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 23 Jan 2026.