Systemic Lupus ErythematosusNCT07155369
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
A study testing UCAR-T cells, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus and Systemic Sclerosis, run by The Affiliated Hospital of Xuzhou Medical University at 1 site in China.
Trial summary
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus, Systemic Sclerosis
- What is being tested?
- UCAR-T cells, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 18 Mar 2025to Sep 2028
- Phase
- Interventional
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years old (inclusive), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- Adequate hepatic, renal and bone marrow function.
- Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.
Who cannot join
- Participants with a history of severe drug allergies or allergic constitutions.
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- Participants with insufficient cardiac function.
- Participants with congenital immunoglobulin deficiencies.
- History of malignancy within five years.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
Read the detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis
- Being tested
- UCAR-T cells, Cyclophosphamide, Fludarabine
- Medical subject headings
- Lupus Erythematosus, Systemic, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCAR-T cellsBiological
UCAR-T cells will be administered intravenously as per the schedule specified in the protocol.
CyclophosphamideDrug
Cyclophosphamide will be administered intravenously.
FludarabineDrug
Fludarabine will be administered intravenously.
| Study group | Role | What they receive |
|---|---|---|
| UCAR T-cell group | Experimental | Participants will receive the following interventions and dose escalated per protocol:
Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine Receives: Biological: UCAR-T cells; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
The incidence and severity of adverse events (AEs)
Measured: 2 years
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases
Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
Measured: 2 years
Secondary outcomes (4)
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
AUC0-28d
Measured: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Cmax
Measured: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Tmax
Measured: 2 years
To characterize pharmacodynamics of of UCAR-T cells in participants.
Changes in B-cell levels in the peripheral blood from baseline.
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Sep 2025
- Study start18 Mar 2025
- Primary completionSep 2026 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical University
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai Xiniao Biotech Co., Ltd.
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07155369
- Sponsor's protocol ID
- QH-XZ-02
- Status last verified
- Sep 2025
- First submitted
- 20 Aug 2025
- Last updated
- 4 Sep 2025
- 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 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07155369
- Acronym / sponsor ID
- QH-XZ-02
- Conditions
- Systemic Lupus Erythematosus, Systemic Sclerosis
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Xiniao Biotech Co., Ltd.
- Study start
- 18 Mar 2025 (actual)
- Primary completion
- Sep 2026 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 4 Sep 2025 (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.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy ofuniversal allogeneic anti-CD19/BCMA CAR T-cells in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CART-cells administered intravenously after a lymphodepleting therapy regimen consisting of fludarabine and cyclophosphamide.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| UCAR T-cell group | Experimental | Biological: UCAR-T cells, Drug: Cyclophosphamide, Drug: FludarabineParticipants will receive the following interventions and dose escalated per protocol: Biological: UCAR-T cells Drug: Cyclophosphamide Drug: Fludarabine |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age ≥ 18 years old (inclusive), regardless of gender.
- Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- Adequate hepatic, renal and bone marrow function.
- Participants with relapsed or refractory autoimmune diseases, Including SLE or SSc.
Key exclusion criteria (5 listed)
- Participants with a history of severe drug allergies or allergic constitutions.
- Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.
- Participants with insufficient cardiac function.
- Participants with congenital immunoglobulin deficiencies.
- History of malignancy within five years.
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 |
|---|---|---|
| UCAR-T cellsUCAR-T cells will be administered intravenously as per the schedule specified in the protocol. | Biological | UCAR T-cell group |
| CyclophosphamideCyclophosphamide will be administered intravenously. | Drug | UCAR T-cell group |
| FludarabineFludarabine will be administered intravenously. | Drug | UCAR T-cell group |
Primary outcome
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Time frame: 2 years
The incidence and severity of adverse events (AEs)
To evaluate the clinical responses and duration of UCAR-T cells in participants with relapse/ refractory autoimmune diseases
Time frame: 2 years
Proportion of participants achieving SRI-4 response, change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
4 secondary outcomes
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Time frame: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Time frame: 2 years
To characterize the cellular kinetics of UCAR T-cell in participants with relapse/ refractory autoimmune diseases
Time frame: 2 years
To characterize pharmacodynamics of of UCAR-T cells in participants.
Time frame: 2 years
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 4 Sep 2025.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease
Systemic Lupus Erythematosus (SLE), Cutaneous Lupus Erythematosus (CLE)
RecruitingPhase 3
A Study of Enpatoran in Participants With Cutaneous Manifestations of Lupus With or Without Systemic Disease (ELOWEN-2)
Systematic Lupus Erythematosus, Cutaneous Lupus Erythematosus
Not yet recruiting
MYTP01 for Immune-Mediated Diseases
IgA Nephropathy, Kidney Transplant Recipients
RecruitingPhase 1/2
Phase I/II Study of AD-PluReceptor Plus Tafasitamab-cxix and Lymphodepleting Chemotherapy in Patients With Autoimmune Disorders
Autoimmune Disorders, Systemic Sclerosis
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. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing UCAR-T cells, Cyclophosphamide and Fludarabine in people with Systemic Lupus Erythematosus and Systemic Sclerosis, run by The Affiliated Hospital of Xuzhou Medical University 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 4 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: under way, not looking for participants, as of the sponsor's last update on 4 Sep 2025. 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.
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?
To evaluate the safety and tolerability of UCAR T-cell in participants with relapse/ refractory autoimmune diseases (time frame: 2 years). 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 4 Sep 2025; AzTrials last refreshed its copy on 5 Nov 2026.