Systemic Lupus ErythematosusPhase 1NCT06978738
UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases
A Phase 1 study testing universal allogeneic anti-CD19/BCMA CAR T-cells in people with Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia, run by Changzhou No.2 People's Hospital 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, Autoimmune Hemolytic Anemia, Myasthenia Gravis
- What is being tested?
- universal allogeneic anti-CD19/BCMA CAR T-cells
- 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
- May 2025to Nov 2028
- 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 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.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- 3.Functional requirements for major organs are as follows:
- Bone marrow function must meet: A. Neutrophil count ≥ 0.5×10 ^ 9/L (no colony-stimulating factor treatment within 2 weeks before examination); B. Hemoglobin ≥ 60g/L; C. Platelets ≥ 30 × 10 ^ 9/L.
- Liver function: Alanine aminotransferase (ALT) ≤ 3×ULN (excluding ALT elevation due to inflammatory myopathy), aspartate aminotransferase (AST)≤3×Upper limit of normal (ULN) (excluding AST elevation due to inflammatory myopathy), TBIL≤1.5×ULN (or ≤ 3.0×ULN for subjects with Gilbert syndrome);
- Renal function: creatinine clearance rate (CrCl) ≥ 30ml/minute (calculated by Cockcroft/Gault formula, acute CrCl decrease due to the target disease is excluded; LN is exluded);
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- 4.ECOG score 0-1.
- 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
- 6.Willing to participate in this clinical study, sign an informed consent form, have good compliance, and cooperate with follow-up.
- 7.Subjects with relapsed or refractory autoimmune diseases, Including relapsed or refractory Autoimmune Hemolytic Anemia, relapsed or refractory Systemic Lupus Erythematosus, relapsed or refractory or Progressive Systemic Sclerosis, relapsed or refractory or Progressive Inflammatory Myopathy, relapsed or refractory ANCA-Associated Vasculitis, relapsed or refractory Immunoglobulin-G4 related disease and relapsed or refractory Myasthenia Gravis.
Who cannot join
- 1.Subjects 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. Subjects with insufficient cardiac function;
- 4. Subjects with congenital immunoglobulin deficiencies;
- 5. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
- 6. Subjects who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA >ULN; subjects positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; individuals positive for human immunodeficiency virus (HIV) antibody; individuals positive for syphilis testing;
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- 7. Subjects with mental illness and severe cognitive dysfunction;
- 8. Pregnant women or women planning to conceive;
- 9.Subjects whom the investigator believes have other reasons that make them unsuitable for inclusion in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
Changzhou No.2 People's Hospital
Changzhou
Lu, Doctor, +86-15295189493, Luxuzhang2008@163.com
About this study
Official title: A Clinical Study Evaluating the Safety and Preliminary 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, Autoimmune Hemolytic Anemia, Myasthenia Gravis, Systemic Sclerosis, ANCA-Associated Vasculitis, Inflammatory Myopathy
- Being tested
- universal allogeneic anti-CD19/BCMA CAR T-cells
- Keywords
- Universal Allogeneic CAR T-cells, CD19/BCMA CAR T-cells
- Medical subject headings
- Lupus Erythematosus, Systemic, Anemia, Hemolytic, Autoimmune, Myasthenia Gravis, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Myositis, Immunoglobulin G4-Related Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
universal allogeneic anti-CD19/BCMA CAR T-cellsBiological
A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells
| Study group | Role | What they receive |
|---|---|---|
| UCAR T-cell group | Experimental | A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells Receives: Biological: universal allogeneic anti-CD19/BCMA CAR 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 UCAR T-cell Infusion
The total number, incidence, and severity of AEs
Measured: Up to 90 days After UCAR T-cell Infusion
Secondary outcomes (9)
AIHA：Rates of CR, CRi, PR, ORR
CR: complete response CRi: Complete Remission with incomplete and compensated hemolysis PR: Partial response ORR: Overall response rate
Measured: Up to 24 Months After UCAR T-cell Infusion
SLE：SLE Response Index 4 (SRI-4)
The SRI-4 (SLE Responder Index-4) response was defined as a reduction of at least 4 points in SLEDAI score compared with the baseline level, no new British Isles Lupus Assessment Group (BILAG) A organ domain score or no more than one new BILAG B organ domain score, and no worsening in the Physician's Global Assessment (PGA) (<0.3 points worsening from the baseline level).
Measured: Up to 24 Months After UCAR T-cell Infusion
SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
SLEDAI stands for Systemic Lupus Erythematosus Disease Activity Index, with a score of 0-6 representing mild disease activity, 7-12 representing moderate disease activity, and 12-16 representing severe disease activity
Measured: Up to 24 Months After UCAR T-cell Infusion
SSc：Change in the modified Rodnan Skin Score (mRSS) from baseline
The modified Rodnan Skin Score (mRSS) describes the thickness of skin in 17 anatomic areas rated from 0 to 3, where 3 indicates the most severe thickening.
Measured: Up to 24 Months After UCAR T-cell Infusion
IIM：The ACR-EULAR Myositis Response Criteria [Total Improvement Score (TIS)]
Total Improvement Score (TIS) contains Physician Global Activity(PGA)，Patient/Parent Global Activity(PtGA)，Manual Muscle Testing(MMT) and Health Assessment Questionnaire(HAQ).
PGA:This partially validated tool measures the global evaluation by the treating physician of the overall disease activity of the patient at the time of assessment using a 10 cm. visual analogue scale and a 5 point Likert scale.
PtGA:This partially validated tool measures the global evaluation by the patient, or by the parent if the patient is a minor, of the patient's overall disease activity at the time of assessment using a 10 cm. visual analogue scale.
MMT:This partially validated tool assesses muscle strength using manual muscle testing (MMT). A 0 - 10 point scale is proposed for use. An abbreviated group of 8 proximal, distal, and axial muscles performs similarly to a total of 24 muscle groups, and is also proposed for use for research studies.
HAQ:Define the health assessement questionnaire.
Measured: Up to 24 Months After UCAR T-cell Infusion
AAV: Change in disease activity as measured by Birmingham Vasculitis Activity Score (BVAS)
The Birmingham Vasculitis Activity (BVAS) form is divided into 9 organ-based systems, with each section including symptoms/signs that are typical of that particular organ involvement in systemic vasculitis. The clinician only scores features believed to be due to active vasculitis. Completion of the form provides a numerical score, which ranges from 0 (best health) to 63 (worst health). A negative percentage change indicated improvement in health.
Measured: Up to 24 Months After UCAR T-cell Infusion
IgG4-RD:IgG4-Related Disease Responder Index (IgG4-RD RI)
The IgG4-RD RI detects change in disease activity and identifies improvements/worsening in the same or different organ systems. It encompasses more than 25 organs/sites and records the following for each organ/site: (i) activity trend (through a 0-3 [normal/resolved - worsening] organ/site score); (ii) presence of symptoms due to active disease; (iii) need for urgent care; (iv) presence of damage; and (v) presence of symptoms due to damage. The final activity score at each visit is obtained by summing all organ/site scores (i) and by doubling items needing urgent care (iii). Higher scores represent greater (i.e. worse) disease activity.
Measured: Up to 24 Months After UCAR T-cell Infusion
MG:Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in MG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe MG.
Measured: Up to 24 Months After UCAR T-cell Infusion
MG:Quantitative Myasthenia Gravis Score (QMG)
The QMG score is a 13-item scale used to quantify disease severity in myasthenia gravis. The scale measures ocular, bulbar, respiratory, and limb function, grading each finding, and ranges from 0 (no myasthenic findings) to 39 (maximal myasthenic deficits).
Measured: Up to 24 Months After UCAR T-cell Infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 May 2025
- Study startMay 2025 (estimated)
- Primary completionMay 2027 (estimated)
- Study completionNov 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changzhou No.2 People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lu Xuzhang, Changzhou No.2 People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06978738
- Sponsor's protocol ID
- QH-CE-01
- Status last verified
- May 2025
- First submitted
- 28 Apr 2025
- Last updated
- 18 May 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 18 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study Evaluating the Safety and Preliminary Efficacy of Universal Allogeneic CAR T-cell Therapy Targeting CD19 and BCMA in Patients With Relapse/Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06978738
- Acronym / sponsor ID
- QH-CE-01
- Conditions
- Systemic Lupus Erythematosus, Autoimmune Hemolytic Anemia, Myasthenia Gravis, Systemic Sclerosis, ANCA-Associated Vasculitis, Inflammatory Myopathy
- Keywords
- Universal Allogeneic CAR T-cells, CD19/BCMA CAR T-cells
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Changzhou No.2 People's HospitalUniversity, hospital or other
- Study start
- May 2025 (estimated)
- Primary completion
- May 2027 (estimated)
- Study completion
- Nov 2028 (estimated)
- First posted
- 18 May 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: universal allogeneic anti-CD19/BCMA CAR T-cellsA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 1.Age ≥ 18 years old (inclusive), regardless of gender.
- 2.Positive expression of CD19 on peripheral blood B cells confirmed by flow cytometry.
- 3.Functional requirements for major organs are as follows:
- 4.ECOG score 0-1.
- 5.Female subjects of childbearing potential and male subjects with partners of childbearing potential must use medically approved contraception or abstinence during the study treatment period and for at least 6 months after the end of the study treatment; Female subjects of childbearing potential must have a negative Human chorionic gonadotropin (HCG) test within 7 days before study enrollment and not be lactating.
Key exclusion criteria (9 listed)
- 1.Subjects 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. Subjects with insufficient cardiac function;
- 4. Subjects with congenital immunoglobulin deficiencies;
- 5. Subjects with a history of malignant tumors within the past five years, except for the following conditions: non-melanoma skin cancer, stage I tumors with a low recurrence probability after complete resection, clinically localized prostate cancer after treatment, cervical carcinoma in situ confirmed by biopsy or squamous intraepithelial lesion shown by smear, and stable papillary thyroid carcinoma or follicular thyroid carcinoma.
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 |
|---|---|---|
| universal allogeneic anti-CD19/BCMA CAR T-cellsA single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells | Biological | UCAR T-cell group |
Primary outcome
The number and severity of dose-limiting toxicity (DLT) events
Time frame: Within 28 Days After UCAR T-cell 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.
The total number, incidence, and severity of AEs
Time frame: Up to 90 days After UCAR T-cell Infusion
9 secondary outcomes
AIHA：Rates of CR, CRi, PR, ORR
Time frame: Up to 24 Months After UCAR T-cell Infusion
SLE：SLE Response Index 4 (SRI-4)
Time frame: Up to 24 Months After UCAR T-cell Infusion
SLE: Change in the Systemic Lupus Erythematosus Disease Activity Index(SLEDAI) from baseline
Time frame: Up to 24 Months After UCAR T-cell Infusion
SSc：Change in the modified Rodnan Skin Score (mRSS) from baseline
Time frame: Up to 24 Months After UCAR T-cell Infusion
IIM：The ACR-EULAR Myositis Response Criteria [Total Improvement Score (TIS)]
Time frame: Up to 24 Months After UCAR T-cell Infusion
AAV: Change in disease activity as measured by Birmingham Vasculitis Activity Score (BVAS)
Time frame: Up to 24 Months After UCAR T-cell Infusion
IgG4-RD:IgG4-Related Disease Responder Index (IgG4-RD RI)
Time frame: Up to 24 Months After UCAR T-cell Infusion
MG:Changes of Myasthenia Gravis Activities of Daily Living (MG-ADL) Score
Time frame: Up to 24 Months After UCAR T-cell Infusion
MG:Quantitative Myasthenia Gravis Score (QMG)
Time frame: Up to 24 Months After UCAR T-cell Infusion
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 18 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing universal allogeneic anti-CD19/BCMA CAR T-cells in people with Systemic Lupus Erythematosus and Autoimmune Hemolytic Anemia, run by Changzhou No.2 People's 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 10 inclusion and 9 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 18 May 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.
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 Xuzhang Lu, Doctor (+86-15295189493, Luxuzhang2008@163.com), or a site near the patient. 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 UCAR T-cell Infusion). 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 18 May 2025.