Systemic Lupus ErythematosusPhase 1NCT05765006
CD19-CART(Relma-cel) for Moderate to Severe Active Systemic Lupus Erythematosus
A Phase 1 study testing Relma-cel in people with Systemic Lupus Erythematosus, run by Shanghai Ming Ju Biotechnology Co., Ltd. at 1 site in China.
Trial summary
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- Relma-cel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2023to 30 Dec 2025
- Phase
- 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 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Sign an informed consent form (ICF) voluntarily.
- At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
- A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
- The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening.
- Standard treatment regimen refers to the steady use of any of the following (alone or in combination) : corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressants or immunomodulators including azathioprine, Mycophenolate Mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
- Oral corticosteroids must meet the following requirements:
Show all 11Show fewer
- Prednisone (or equivalent) ≥7.5 mg/ day, and ≤30 mg/ day.
- There is no minimum daily dose requirement for corticosteroids when used in combination with immunosuppressants.
- At least 8 weeks of treatment prior to screening, and the dose must be kept stable for > 2 weeks.
- 5. Screening is positive for antinuclear antibodies, and/or anti-DS-DNA antibodies, and/or anti-Smith antibodies.
- 6. SELENA-SLEDAI score ≥8 during the screening period. Score ≥6 for SELENA-SLEDAI clinical symptoms (except for low complement and/or anti-DS-DNA antibodies) if low complement and/or anti-DS-DNA antibody score is present.
Who cannot join
- Severe lupus nephritis (defined as proteinuria > 6 g/24h or serum creatinine > 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to screening mg/d or equivalent glucocorticoid therapy ≥14 days.
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
- Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Combined with other autoimmune diseases, systematic treatment is needed.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- IgA deficiency was present during screening (serum IgA level < 10 mg/dL)
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Relma-cel Medical
Shanghai
medical Relma-cel
chunli Mei
About this study
Official title: A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
Read the detailed description
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics(PK) and pharmacodynamics(PD) of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
There will be 4 dose level (15x106 CAR+ T cells as the back up dose ,25x106 CAR+ T cells as the starting dose 、50x106 CAR+ T cells and 100x106(or 150 x106CAR+ T cells）Dose escalation, to evaluate the safety、 tolerability of Relma-cel in adult subjects of SLE and determine RP2D .
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- Relma-cel
- Keywords
- Relma-cel, Systemic lupus erythematosus, CD19-CART
- 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.
Relma-celBiological
CD19-targeted Chimeric AntigenReceptor (CAR) T Cells; Relma-cel be administrated at four dose level:25×106 CAR+ T cells、50×106 CAR+ T cells、100×106 CAR+ T cells/150×106 CAR+ T cells
| Study group | Role | What they receive |
|---|---|---|
| Relma-cel be administrated in four dose level | Experimental | Not described Receives: Biological: Relma-cel |
What is being measured
The primary outcome is the main question the study is designed to answer.
DLT rate
The incidence of dose-limiting toxicity
Measured: 3 months
determine RP2D
To determine RP2D(Phase 2 recommended dose)
Measured: 3 months
Secondary outcomes (4)
SELENA-SLEDAI （Safety of Estrogens in Systemic Lupus Erythematosus National Assessment） score； 0 to 4 is basically no disease activity; 5 to 9 is light activity; 10 to 14 is moderate activity;≥15 is considered heavy activity.
SELENA-SLEDAI score taken up to 3 months after CD19 cCAR T cells infusion
Measured: 3 months
BILAG -2004（updated version of british isles lupus assessment group ） level；The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.
BILAG-2004 level taken up to 3 months after CD19 cCAR T cells infusion
Measured: 3 months
PGA (physician global assessment) score,The PGA scale ranges from "no disease activity" (0) to the "most severe disease activity" (3).the score is between 0 to 3.
PGA score taken up to 3 months after CD19 cCAR T cells infusion
Measured: 3 months
Autoantibody detection
Autoantibody detection up to 3 months after CD19 cCAR T cells infusion
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Mar 2023
- Study start24 Feb 2023
- Primary completion30 Dec 2024 (estimated)
- Study completion30 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- 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
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- yu Hu, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technologyheng Mei, Principal investigator, Union Hospital, Tongji Medical College, Huazhong University of Science and Technologyliangjing Lv, Principal investigator, Renji Hospital Shanghai Jiaotong University School of Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05765006
- Sponsor's protocol ID
- JWCAR029012
- Status last verified
- Mar 2023
- First submitted
- 6 Feb 2023
- Last updated
- 15 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Kaufman JL, Deak ST, Erdman W. Radionuclide scans to define patterns of occult myonecrosis. N J Med. 1986 Feb;83(2):101-3. No abstract available.
PubMed 3005930Shu J, Xie W, Mei C, Ren A, Ke S, Ma M, Zhou Z, Hu Y, Mei H. Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial. EClinicalMedicine. 2025 Apr 30;83:103229. doi: 10.1016/j.eclinm.2025.103229. eCollection 2025 May.
PubMed 40386685
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Dose-escalation Study Evaluate the Safety Tolerability Pharmacokinetics(PK) and Pharmacodynamics(PD) of Relma-cel in Subjects With Moderate to Severe Active Systemic Lupus Erythematosus (SLE)
- ClinicalTrials.gov ID
- NCT05765006
- Acronym / sponsor ID
- JWCAR029012
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- Relma-cel, Systemic lupus erythematosus, CD19-CART
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Shanghai Ming Ju Biotechnology Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 30 Dec 2024 (estimated)
- Study completion
- 30 Dec 2025 (estimated)
- First posted
- 13 Mar 2023 (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 a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics and pharmacodynamics of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
Detailed description
This is a phase I, open-label, single-arm, multicenter study to asess the safety tolerability pharmacokinetics(PK) and pharmacodynamics(PD) of Relma-cel in moderate or severe active systemic lupus erythematosus (SLE) subjects in China.
There will be 4 dose level (15x106 CAR+ T cells as the back up dose ,25x106 CAR+ T cells as the starting dose 、50x106 CAR+ T cells and 100x106(or 150 x106CAR+ T cells）Dose escalation, to evaluate the safety、 tolerability of Relma-cel in adult subjects of SLE and determine RP2D .
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Relma-cel be administrated in four dose level | Experimental | Biological: Relma-cel |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Sign an informed consent form (ICF) voluntarily.
- At the time of signing the ICF, you must be between 18 and 70 years old (inclusive), male or female.
- A diagnosis of SLE according to the 1997 revised criteria of the American College of Rheumatology (ACR).
- The history of SLE prior to screening was at least 6 months, and the disease remained active at least 2 months after the use of a stable standard SLE regimen prior to screening.
- Standard treatment regimen refers to the steady use of any of the following (alone or in combination) : corticosteroids, antimalarials, non-steroidal anti-inflammatory drugs (NSAIDs), and other immunosuppressants or immunomodulators including azathioprine, Mycophenolate Mofetil, cyclophosphamide, methotrexate, leflunomide, tacrolimus, and cyclosporine.
Key exclusion criteria (6 listed)
- Severe lupus nephritis (defined as proteinuria > 6 g/24h or serum creatinine > 2.5 mg/dL or 221 μmol/L), treatment with active nephritis with Prohibited drugs, hemodialysis, or prednisone ≥100 within 8 weeks prior to screening mg/d or equivalent glucocorticoid therapy ≥14 days.
- Prior to screening, other lupus crises, such as active central nervous system lupus, severe hemolytic anemia, severe thrombocytopenic purpura, severe agranulocytosis, severe myocardial damage, severe lupus pneumonia or pulmonary hemorrhage, severe lupus hepatitis, and severe vasculitis.
- Clinically significant central nervous system diseases or pathological changes not caused by lupus prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/convulsions, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- Combined with other autoimmune diseases, systematic treatment is needed.
- History of major organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
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 |
|---|---|---|
| Relma-celCD19-targeted Chimeric AntigenReceptor (CAR) T Cells; Relma-cel be administrated at four dose level:25×106 CAR+ T cells、50×106 CAR+ T cells、100×106 CAR+ T cells/150×106 CAR+ T cells | Biological | Relma-cel be administrated in four dose level |
Primary outcome
DLT rate
Time frame: 3 months
The incidence of dose-limiting toxicity
determine RP2D
Time frame: 3 months
To determine RP2D(Phase 2 recommended dose)
4 secondary outcomes
SELENA-SLEDAI （Safety of Estrogens in Systemic Lupus Erythematosus National Assessment） score； 0 to 4 is basically no disease activity; 5 to 9 is light activity; 10 to 14 is moderate activity;≥15 is considered heavy activity.
Time frame: 3 months
BILAG -2004（updated version of british isles lupus assessment group ） level；The BILAG 2004 index categorizes disease activity into 5 different levels from A-E.Grade A represents very active disease.
Time frame: 3 months
PGA (physician global assessment) score,The PGA scale ranges from "no disease activity" (0) to the "most severe disease activity" (3).the score is between 0 to 3.
Time frame: 3 months
Autoantibody detection
Time frame: 3 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2023.
- Results publication: PubMed 3005930Kaufman JL, Deak ST, Erdman W. Radionuclide scans to define patterns of occult myonecrosis. N J Med. 1986 Feb;83(2):101-3. No abstract available.
- Derived from this study: PubMed 40386685Shu J, Xie W, Mei C, Ren A, Ke S, Ma M, Zhou Z, Hu Y, Mei H. Safety and clinical efficacy of Relmacabtagene autoleucel (relma-cel) for systemic lupus erythematosus: a phase 1 open-label clinical trial. EClinicalMedicine. 2025 Apr 30;83:103229. doi: 10.1016/j.eclinm.2025.103229. eCollection 2025 May.
- 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.
yu Hu principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
heng Mei principal investigator
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
liangjing Lv principal investigator
Renji Hospital Shanghai Jiaotong University School of Medical
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 Relma-cel in people with Systemic Lupus Erythematosus, run by Shanghai Ming Ju Biotechnology Co., Ltd. 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 11 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 15 Mar 2023. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact medical JW (+86 21 50464201, Relma-celMedical@jwtherapeutics.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
DLT rate (time frame: 3 months). 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?
On the ClinicalTrials.gov record for NCT05765006, which also lists 2 linked publications.
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 15 Mar 2023.