Systemic Lupus ErythematosusEarly Phase 1NCT07410377
UCAR T-cell Therapy Targeting CD19/ BCMA(QT-019C) in Patients With Relapse/ Refractory Autoimmune Diseases
A Early Phase 1 study testing UCAR-T cells in people with Systemic Lupus Erythematosus and Inflammatory Myopathy, 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（QT-019C） 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, Inflammatory Myopathy
- What is being tested?
- UCAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- 1 siteChina
- Study dates
- Mar 2026to Sep 2028
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
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
- 1. Age ≥ 18 years old (inclusive), regardless of gender. 2. Adequate hepatic, renal and bone marrow function.3 Participants with relapsed or refractory autoimmune diseases, Including SLE or IM.
Who cannot join
- 1. Participants with a history of severe drug allergies or allergic constitutions.2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.3. Participants with insufficient cardiac function.4. Participants with congenital immunoglobulin deficiencies.5. 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(QT-019C) 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（QT-019C） in With Relapse/Refractory Autoimmune Diseases.
Read the detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of cyclophosphamide.
- Being tested
- UCAR-T cells
- Medical subject headings
- Lupus Erythematosus, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UCAR-T cellsBiological
QT-019C will be administered intravenously as per the schedule specified in the protocol.
| 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（QT-019C） Drug: Cyclophosphamide Receives: Biological: UCAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number and severity of dose-limiting toxicity (DLT) events
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
Measured: Within 28 Days After QT-019C infusion
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 (1)
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 posted13 Feb 2026
- Study startMar 2026 (estimated)
- Primary completionMar 2027 (estimated)
- Study completionSep 2028 (estimated)
Why it stopped: Internal decision.
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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
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
- NCT07410377
- Sponsor's protocol ID
- QH-XZ-03
- Status last verified
- May 2026
- First submitted
- 8 Feb 2026
- Last updated
- 28 May 2026
- 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 28 May 2026. 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(QT-019C) in Patients With Relapse/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07410377
- Acronym / sponsor ID
- QH-XZ-03
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Internal decision.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- The Affiliated Hospital of Xuzhou Medical UniversityUniversity, hospital or other
- Collaborators
- Shanghai Xiniao Biotech Co., Ltd.
- Study start
- Mar 2026 (estimated)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 13 Feb 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.
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in With Relapse/Refractory Autoimmune Diseases.
Detailed description
This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells（QT-019C） in Patients With Relapse/Refractory Autoimmune Diseases.
Study intervention consists of a single infusion of universal allogeneic CAR T-cells administered intravenously after a lymphodepleting therapy regimen consisting of 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 cellsParticipants will receive the following interventions and dose escalated per protocol: Biological: UCAR-T cells（QT-019C） Drug: Cyclophosphamide |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Age ≥ 18 years old (inclusive), regardless of gender. 2. Adequate hepatic, renal and bone marrow function.3 Participants with relapsed or refractory autoimmune diseases, Including SLE or IM.
Key exclusion criteria (1 listed)
- 1. Participants with a history of severe drug allergies or allergic constitutions.2. Presence or suspicion of uncontrolled or treatment-required fungal, bacterial, viral, or other infections.3. Participants with insufficient cardiac function.4. Participants with congenital immunoglobulin deficiencies.5. 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 cellsQT-019C will be administered intravenously as per the schedule specified in the protocol. | Biological | UCAR T-cell group |
Primary outcome
The number and severity of dose-limiting toxicity (DLT) events
Time frame: Within 28 Days After QT-019C infusion
DLT will be graded according to the NCI Common Terminology Criteria for Adverse Events (CTCAE) Version 5.0, and the ASTCT Consensus Grading for Cytokine Release Syndrome and Neurologic Toxicity Associated with Immune Effector Cells.
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
1 secondary outcome
To characterize pharmacodynamics of of UCAR-T cells in participants.
Time frame: 2 years
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 May 2026.
- 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. 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 Early Phase 1 study testing UCAR-T cells in people with Systemic Lupus Erythematosus and Inflammatory Myopathy, 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 28 May 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?
The study was withdrawn before enrolling participants, so there are no results.
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 number and severity of dose-limiting toxicity (DLT) events (time frame: Within 28 Days After QT-019C infusion). The study lists 3 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 28 May 2026.