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Relapsed/Refractory B Cell-Mediated Autoimmune DiseasesEarly Phase 1RXIM002NCT07322718

Safety and Efficacy Study of RXIM002 in Severe, Relapsed or Refractory Autoimmune Diseases

A Early Phase 1 study testing RXIM002 product in people with Relapsed/Refractory B Cell-Mediated Autoimmune Diseases, run by Ruijin Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
RXIM002 product
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
27 participants
Where
1 siteChina
Study dates
24 Dec 2025to 19 Mar 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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Subjects voluntary agreement to provide written informed consent.
  • Aged 18 to 65 years, either sex.
  • Adequate organ function meeting screening criteria.
  • Positive test for cluster of differentiation antigen 19 (CD19).
  • Systemic Lupus Erythematosus (SLE) and Lupus Nephritis (LN):
  • Have been diagnosed with SLE or LN before screening.
Show all 32Show fewer
  • Presence of anti-dsDNA, anti-histone, anti-chromatin, anti-Ro (anti-SS-A), anti-La (anti-SS-B), antinuclear antibody (ANA), or anti-Sm antibodies at screening.
  • Active disease at screening.
  • Fulfill relapsed/refractory SLE or LN conditions
  • Lupus Nephritis (LN) :
  • Kidney biopsy result indicating LN
  • Evidence of LN disease activity
  • Systemic Sclerosis (SSc):
  • Have been diagnosed with SSc before screening.
  • Antinuclear Antibody (ANA) positive at screening or prior to screening. AND, evidence of SSc disease activity.
  • Fulfill relapsed/refractory SSc conditions.
  • Immune Thrombocytopenia (ITP):
  • Have been diagnosed with refractory ITP before screening.
  • Platelet count <50×10⁹/L at screening.
  • Idiopathic Inflammatory Myopathy (IIM):
  • Have been diagnosed with IIM before screening.
  • Presence of at least 1 myositis specific (MSA), associated antibody (MAA), or ANA at screening or prior to screening.
  • Evidence of IIM disease activity.
  • Fulfill relapsed/refractory IIM conditions.
  • Membranous Nephropathy (MN):
  • Have been diagnosed with MN before screening.
  • Active MN patients meeting screening criteria.
  • Fulfill relapsed/refractory MN conditions.
  • Autoimmune Hemolytic Anemia (AIHA):
  • Have been diagnosed with AIHA before screening.
  • Active AIHA patients meeting screening criteria.
  • Fulfill relapsed/refractory AIHA conditions.

Who cannot join

  • Active infections such as hepatitis and tuberculosis.
  • Other autoimmune diseases.
  • Serious underlying diseases such as active malignancies, uncontrolled diabetes.
  • Female subjects who were pregnant, breastfeeding.
  • Any uncontrolled psychiatric disorders (e.g., schizophrenia, bipolar disorder, eating disorders, major depression or anxiety disorder), as declared by the participant or reported in the medical records.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Qiongyi Hu contact

+86 021-50199835

huqiongyi131@163.com

China1 site, 1 recruiting

  • Ruijin Hospital

    Shanghai, Huangpu District, No. 197, Ruijin 2nd Road

    Hu Qiongyi Hu Qiongyi, Doctor, 086+15062338287, huqiongyi131@163.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study to Evaluate the Safety, Tolerability and Preliminary Efficacy of the CD19-Targeting Circular RNA Product RXIM002 in Patients With Relapsed or Refractory B Cell-Mediated Autoimmune Diseases

This Phase 1, open-label study evaluates the safety, tolerability, and preliminary efficacy of RXIM002, a CD19-targeting circular RNA-mediated in-vivo CAR T-cell therapy, in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases.

Read the detailed description

This Phase 1, open-label, single-arm, dose-escalation study is designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, immunogenicity, and preliminary efficacy of RXIM002 in adults with severe, relapsed, or refractory B cell-mediated autoimmune diseases. Eligible participants will receive intravenous administration of RXIM002 and will be monitored for adverse events, laboratory parameters, and other safety outcomes. The study will also explore biological activity and potential clinical responses across the enrolled autoimmune conditions. Participants will be followed for a defined period after treatment to assess longer-term safety and durability of any observed effects. The study will include the following sequential phases: screening, treatment, and follow-up.

Being tested
RXIM002 product
Keywords
Autoimmune Disease
Medical subject headings
Recurrence, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RXIM002 productBiological

    Prior to infusion of the RXIM002 product, subjects will receive pre-medication if needed

Study groups in NCT07322718
Study groupRoleWhat they receive
RXIM002ExperimentalEach study participant will be given 2 doses of RXIM002 at each dose level.
Receives: Biological: RXIM002 product

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence and severity of Dose-Limiting Toxicities (DLTs)

    Measured: 28 days after RXIM002 first infusion (Day 1)

  2. Incidence and severity of treatment-emergent adverse events (TEAEs)

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

  3. CAR positive cell Cmax

    CAR positive T cells in peripheral blood after RXIM002 infusion, maximum concentration (Cmax).

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  4. CAR positive cell Tmax

    CAR positive T cells levels in peripheral blood after RXIM002 infusion, time to Cmax (Tmax).

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  5. CAR positive cell AUC

    CAR positive T cells levels in peripheral blood after RXIM002 infusion, area under the concentration-time curve (AUC) .

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

Secondary outcomes (13)

  1. LNP (Lipid Nanoparticle) Cmax

    LNP in peripheral blood after RXIM002 infusion, maximum concentration (Cmax).

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  2. LNP (Lipid Nanoparticle) Tmax

    LNP levels in peripheral blood after RXIM002 infusion, time to Cmax (Tmax)

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  3. LNP (Lipid Nanoparticle) AUC

    LNP levels in peripheral blood after RXIM002 infusion, area under the concentration-time curve (AUC) .

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  4. CircleRNA Cmax

    CircleRNA in peripheral blood after RXIM002 infusion, maximum concentration (Cmax).

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  5. CircleRNA Tmax

    CircleRNA levels in peripheral blood after RXIM002 infusion, time to Cmax (Tmax).

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  6. CircleRNA AUC

    CircleRNA levels in peripheral blood after RXIM002 infusion, area under the concentration-time curve (AUC) .

    Measured: 24 weeks after RXIM002 first infusion (Day 1)

  7. Systemic Lupus Erythematosus (SLE) disease activity: Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    Change in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) scores from baseline up to 52 weeks, a total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

  8. Systemic Sclerosis (SSc) disease activity :Modified rodnan skin score(mRSS)

    Change in modified Rodnan skin score (mRSS) from baseline up to 52 weeks in SSc patients. The mRSS is used to assess skin thickness and scope of SSc patients ,with a total score can fall between 0 and 51, with a higher score representing a more significant degree of skin involvement.

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

  9. Idiopathic Inflammatory Myopathy (IIM) disease activity ：Manual muscle test-8

    Change in manual muscle testing (MMT-8) score from baseline up to 52 weeks in IIM patients. This tool assesses muscle strength by testing 8 proximal, distal, and axial muscles ,assess unilateral(score range 0-80 points)handedness side, with a lower score representing a more significant degree of muscle involvement.

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

  10. Autoimmune Hemolytic Anemia (AIHA) disease activity: Overall Hb therapeutic response

    At least one occurrence of Hb ≥ 100 g/L, concurrently with an increase of at least 20 g/L from baseline, and not attributable to red blood cell transfusion or other emergency therapeutic drugs

    Measured: 8 weeks after RXIM002 first infusion (Day 1)

  11. Immune Thrombocytopenia (ITP) disease activity: Overall response of platelet increment.

    The proportion of subjects whose platelet count recovered to ≥ 50 × 10^9/L and who did not require an increase in corticosteroid dose

    Measured: 8 weeks after RXIM002 first infusion (Day 1)

  12. Lupus Nephritis (LN) disease activity: Proportion of subjects achieving Primary Efficacy Renal Response(PERR)

    UPCR ≤ 0.7 g/g, with eGFR no more than 20% below the pre-lupus flare level or ≥ 60 mL/min/1.73 m², and no treatment failure event. Achieving Complete Renal Response (CRR)

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

  13. Membranous Nephropathy (MN) disease activity: Clinical remission rate

    24-hour urinary protein quantification < 3.5 g/day with serum albumin > 30 g/L, and eGFR ≥ 85% of baseline value

    Measured: 52 weeks after RXIM002 first infusion (Day 1)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 Jan 2026
  2. Study start24 Dec 2025
  3. Primary completion19 Dec 2027 (estimated)
  4. Study completion19 Mar 2028 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
27 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07322718
Sponsor's protocol ID
RX-AID-CS101
Acronym
RXIM002
Status last verified
Dec 2025
First submitted
7 Dec 2025
Last updated
23 Jan 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Early Phase 1 study testing RXIM002 product in people with Relapsed/Refractory B Cell-Mediated Autoimmune Diseases, run by Ruijin Hospital at 1 site in China.

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 32 inclusion and 5 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: looking for participants now, 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.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

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?

Contact Qiongyi Hu (+86 021-50199835, huqiongyi131@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence and severity of Dose-Limiting Toxicities (DLTs) (time frame: 28 days after RXIM002 first infusion (Day 1)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07322718.

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.

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