SLE - Systemic Lupus ErythematosusEarly Phase 1NCT07274059
Allogeneic UCB-derived CAR-T for SLE
A Early Phase 1 study testing allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA in people with SLE - Systemic Lupus Erythematosus, run by Chengdu Ucello Biotechnology Co., Ltd. at 2 sites in China.
Trial summary
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- SLE - Systemic Lupus Erythematosus
- What is being tested?
- allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesChina
- Study dates
- 26 Mar 2025to 31 Dec 2037
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 to 75 years (inclusive), regardless of gender.
- Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
- Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.
- Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.
- Adequate function of major organs as follows:
- Bone marrow function: a. Neutrophil count ≥ 1 × 10⁹/L (no colony-stimulating factor therapy within 2 weeks prior to testing, excluding neutropenia caused by SLE); b. Hemoglobin ≥ 60 g/L.
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- Liver function: Alanine aminotransferase (ALT) ≤ 3 × upper limit of normal (ULN) (excluding ALT elevation caused by SLE); Aspartate aminotransferase (AST) ≤ 3 × ULN (excluding AST elevation caused by SLE); Total bilirubin (TBIL) ≤ 1.5 × ULN (excluding TBIL elevation caused by SLE).
- Renal function: Creatinine clearance rate (CrCl) ≥ 30 mL/minute (calculated by Cockcroft/Gault formula, excluding CrCl reduction caused by SLE).
- Coagulation function: International normalized ratio (INR) ≤ 1.5 × ULN; Prothrombin time (PT) ≤ 1.5 × ULN.
- Cardiac function: Hemodynamically stable.
- Female subjects of childbearing potential and male subjects whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse during the study treatment period and for at least 6 months after the end of study treatment. Female subjects of childbearing potential must have a negative serum human chorionic gonadotropin (HCG) test within 7 days prior to study enrollment and must not be breastfeeding.
- Voluntarily agrees to participate in the clinical study, signs the informed consent form (ICF), and demonstrates good compliance with study procedures and follow-up.
Who cannot join
- History of severe drug allergies or atopic diathesis.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Cardiac function insufficient to tolerate the study treatment.
- Congenital immunoglobulin deficiency.
- History of malignant tumors within the past 5 years.
- End-stage renal failure.
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- Positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the lower limit of detection; positive for hepatitis C virus (HCV) antibody with positive peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; positive syphilis test.
- History of mental illness or severe cognitive impairment.
- Use of disease-modifying immunosuppressive agents within 5 half-lives or biological agents within 4 weeks prior to enrollment.
- Pregnant females or females planning to become pregnant.
- Other conditions deemed by the investigator to preclude study participation.
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Not yet recruiting
The General Hospital of Western Theater Command
Chengdu, Sichuan
lin Ling, Bachelor's degree, +8602886570332, linglinlam@163.com
Tao Wang, M.D.
- Recruiting
Yancheng Third People's Hospital
Yancheng, Jiangsu
Dongmei Jiang, M.D., +86051581606513, penghaokuaile@163.com
Jing Zhao, M.S., +86051581608812, ycsyllsc@163.com
About this study
Official title: Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
Read the detailed description
- The main questions it aims to answer are: What CAR-T-related adverse events (AEs) occur within 3 months after the UCAR-T cell infusion? Which dose level is the optimal biological dose (OBD)? What are the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?
- Participants will may receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) if clinically needed. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. Receive UCAR-T cells infusion on Day 0. Then be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after UCAR-T cells infusion.
- Conditions
- SLE - Systemic Lupus Erythematosus
- Being tested
- allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
- Keywords
- allogeneic, CAR-T, umbilical cord blood, SLE
- Medical subject headings
- Lupus Erythematosus, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMADrug
intravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA
| Study group | Role | What they receive |
|---|---|---|
| UCAR-T cells treatment | Experimental | Not described Receives: Drug: allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA |
What is being measured
The primary outcome is the main question the study is designed to answer.
the incidence rate of Dose limited toxicity (DLTs)
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.
Measured: Up to 28 days after infusion
the rate of adverse events
The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.
Measured: up to 2 months after UCAR-T injection
Secondary outcomes (7)
Proportion of patients achieving DORIS remission
Measured: up to 2 years after UCAR-T injection
the changes of SELENA-SLEDAI score
Measured: up to 2 years after UCAR-T injection
Proportion of patients achieving SRI-4 remission
Measured: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of drug-free DORIS remission
Measured: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of LLDAS
Measured: up to 2 years after UCAR-T injection
the changes of BILANG 2004 score
The BILAG 2004 score is a validated clinical assessment tool for systemic lupus erythematosus (SLE), which evaluates disease activity across 9 organ systems (constitutional, cutaneous, mucous membrane, musculoskeletal, renal, neurological, cardiovascular, respiratory, and hematological) using a 5-point grading scale (A=active/severe, B=active/mild-moderate, C=stable/minor activity, D=inactive, E=not involved) to guide treatment decisions and monitor therapeutic responses in clinical practice and research.
Measured: up to 2 years after UCAR-T injection
the changes of Physician's Global Assessment (PGA)
Measured: up to 2 years after UCAR-T injection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Dec 2025
- Study start26 Mar 2025
- Primary completion31 Dec 2035 (estimated)
- Study completion31 Dec 2037 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE - 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
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chengdu Ucello Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Western Theater Command, Yancheng Third People's Hospital
- Responsible party
- Sponsor
- Investigators
- Tao Wang, M.D., Principal investigator, The General Hospital of Western Theater CommandMei Dong Jiang, M.D., Principal investigator, Yancheng Third People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07274059
- Sponsor's protocol ID
- UDCAR-SLE
- Status last verified
- Dec 2025
- First submitted
- 22 Nov 2025
- Last updated
- 10 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The safety and efficacy data will be shared in a publication.
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety and Efficacy of Allogeneic, Umbilical Cord Blood Derived CAR T-cell Therapy for Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07274059
- Acronym / sponsor ID
- UDCAR-SLE
- Conditions
- SLE - Systemic Lupus Erythematosus
- Keywords
- allogeneic, CAR-T, umbilical cord blood, SLE
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Chengdu Ucello Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Collaborators
- The General Hospital of Western Theater Command, Yancheng Third People's Hospital
- Study start
- 26 Mar 2025 (actual)
- Primary completion
- 31 Dec 2035 (estimated)
- Study completion
- 31 Dec 2037 (estimated)
- First posted
- 10 Dec 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.
The purpose of this clinical trial is to learn if allogeneic, umbilical cord blood-derived chimeric antigen receptor T-cell (UCAR-T) targeting CD19 and BCMA works to treat refractory SLE in adults. It will also learn about the safety and efficacy of the UCAR-T cell product.
Detailed description
- The main questions it aims to answer are: What CAR-T-related adverse events (AEs) occur within 3 months after the UCAR-T cell infusion? Which dose level is the optimal biological dose (OBD)? What are the changes of disease activity status, proportion of patients achieving DORIS remission, percentage of participants achieving maintenance of drug-free DORIS remission, proportion of patients achieving SRI-4 remission, percentage of participants achieving maintenance of LLDAS?
- Participants will may receive lymphodepletion chemotherapy (fludarabine plus cyclophosphamide) if clinically needed. If lymphodepletion chemotherapy is administered, rest for 2 days on Day -2 and Day -1. Receive UCAR-T cells infusion on Day 0. Then be hospitalized for at least 7 days post-infusion for close safety monitoring and remain within 2 hours of the treatment facility for at least 28 days. Visit the clinic at Day 14, Day 28, month 3, month 6, month 9, month 12, month 18 and month 24 after UCAR-T cells infusion.
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 cells treatment | Experimental | Drug: allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18 to 75 years (inclusive), regardless of gender.
- Definitive diagnosis of systemic lupus erythematosus (SLE) meeting the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR) classification criteria for SLE
- Treatment refractory: failed ≥ 2 conventional SLE treatments for at least 3 months.
- Disease activity assessed by SELENA-SLEDAI score ≥ 6 with at least one British Isles Lupus Assessment Group (BILAG)-2004 Class A (severe manifestation) or two Class B (moderate manifestation) organ scores (or both); OR SELENA-SLEDAI score ≥ 8.
- Adequate function of major organs as follows:
Key exclusion criteria (11 listed)
- History of severe drug allergies or atopic diathesis.
- Presence or suspicion of uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Cardiac function insufficient to tolerate the study treatment.
- Congenital immunoglobulin deficiency.
- History of malignant tumors within the past 5 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 |
|---|---|---|
| allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMAintravenous injection of allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA | Drug | UCAR-T cells treatment |
Primary outcome
the incidence rate of Dose limited toxicity (DLTs)
Time frame: Up to 28 days after infusion
Dose limited toxicity(DLT) was defined as the occurrence of any of the following adverse events within 28 days of the infusion of UCAR-T cells.
the rate of adverse events
Time frame: up to 2 months after UCAR-T injection
The number, frequency, severity, and laboratory findings of all treatment-related adverse events/serious adverse events are included.
7 secondary outcomes
Proportion of patients achieving DORIS remission
Time frame: up to 2 years after UCAR-T injection
the changes of SELENA-SLEDAI score
Time frame: up to 2 years after UCAR-T injection
Proportion of patients achieving SRI-4 remission
Time frame: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of drug-free DORIS remission
Time frame: up to 2 years after UCAR-T injection
Percentage of participants achieving maintenance of LLDAS
Time frame: up to 2 years after UCAR-T injection
the changes of BILANG 2004 score
Time frame: up to 2 years after UCAR-T injection
the changes of Physician's Global Assessment (PGA)
Time frame: up to 2 years after UCAR-T injection
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 10 Dec 2025.
- Individual participant dataSharing planned: Yes. The safety and efficacy data will be shared in a publication.
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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.
Tao Wang, M.D. principal investigator
The General Hospital of Western Theater Command
Mei Dong Jiang, M.D. principal investigator
Yancheng Third People's Hospital
2 sites 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 allogeneic umbilical cord blood-derived CAR-T targeting CD19 and BCMA in people with SLE - Systemic Lupus Erythematosus, run by Chengdu Ucello Biotechnology Co., Ltd. at 2 sites 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 12 inclusion and 11 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 10 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 Tao Wang, M.D. (+8613550080505, cdjqzyywt@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
the incidence rate of Dose limited toxicity (DLTs) (time frame: Up to 28 days after 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 10 Dec 2025; AzTrials last refreshed its copy on 28 Oct 2026.