Systemic Lupus Erythematosus (SLE)Phase 1NCT06892145
Clinical Trial of CD19 Targeted CAR-T Cell in Refractory Adult SLE
A Phase 1 study testing MC-1-50 in people with Systemic Lupus Erythematosus (SLE) and Refractory, run by Chongqing Precision Biotech Co., Ltd at 2 sites in China.
Trial summary
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus (SLE), Refractory
- What is being tested?
- MC-1-50
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 2 sitesChina
- Study dates
- 12 Jun 2025to 16 Feb 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
- The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
- Age ≥ 18 years old , gender not limited;
- Patients diagnosed with SLE according to the 2019 EULAR/ACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg/kg/d prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;
- SLEDAI-2K score ≥7 points;
- Autoantibody test results are positive: ANA antibody positive and/or serum anti-DSDNA positive;
- Adequate renal, hepatic, pulmonary and cardiac function defined as:
Show all 14Show fewer
- Cardiac function: Echocardiography indicates left ventricular ejection fraction ≥ 50%;
- Renal function: serum creatinine ≤ 2.0 × ULN, or creatinine clearance rate ≥ 60ml/min (Cockcroft Gault formula);
- Hepatic function: ALT and AST ≤ 3.0 × ULN (may be relaxed to ≤ 3.0 × ULN in cases of combined liver infiltration);
- Total bilirubin ≤ 2.0 × ULN (Gilbert syndrome requires total bilirubin ≤ 3.0 × ULN);
- Pulmonary function: Blood oxygen saturation is ≥ 92% in non oxygen state.
- No serious mental disorders;
- Meet standards for apheresis or venous blood collection, and no other cell collection contraindications;
- Women of childbearing age who have a negative blood pregnancy test and all subjects agree to use reliable and effective contraceptive methods (excluding safe period contraception) for contraception within one year after receiving MC-1-50 cell infusion from the time of signing the informed consent form. Including but not limited to: abstinence, implantable progestogen contraceptives that can inhibit ovulation; Intrauterine device (IUD); Intrauterine hormone release system; Spouse vasectomy; Compound hormone contraceptives that can inhibit ovulation (oral, vaginal, and transdermal); Progesterone contraceptives (oral or injectable) that can inhibit ovulation; When male subjects have sex with fertile women, they must agree to use barrier contraception (such as condom plus spermicidal foam/gel/film/emulsion/suppository). At the same time, participants should commit not to donate eggs (oocytes, oocytes) or sperm for assisted reproduction within one year after cell infusion.
Who cannot join
- There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;
- Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg/kg/ day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;
- There were other lupus crises that were not controlled at the time of screening;
- Individuals who have received CAR-T therapy or other gene modified cell therapies;
- Combined with other autoimmune diseases requiring systemic treatment;
- HBsAg or HBcAb positive and HBV DNA test greater than the normal range;HCV antibody positive and HCV RNA detection greater than the normal range;HIV antibody positive;Treponema pallidum antibody positive;
Show all 20Show fewer
- Suffered from any of the following heart diseases:
- New York Heart Association (NYHA) stage III or IV congestive heart failure;
- Within the 6 months prior to enrollment, there has been a myocardial infarction, or a coronary artery bypass grafting (CABG) or stent implantation surgery has been performed;
- History of ventricular arrhythmias requiring treatment or unexplained syncope (excluding cases caused by vasovagal or dehydration);
- History of severe non-ischemic cardiomyopathy;
- Uncontrollable infection in the 1 weeks before enrollment;
- History of solid organ transplantation or hematopoietic stem cell transplantation prior to screening；
- Cerebrovascular accident or seizure occurred within 6 months prior to screening；
- Deep vein or deep artery embolism event within the past 6 months prior to screening;
- history of malignant neoplasms (other than tumors with no active lesion and ending treatment > 2 years ago, and adequately treated cervical carcinoma in situ, basal cell or squamous cell skin cancer, local prostate cancer after radical surgery, and ductal carcinoma in situ after radical surgery);
- (attenuated) Live vaccine ≤ 4 weeks prior to screening;
- Have participated in other clinical trials within one month or five drug half lives (whichever is shorter) before enrollment;
- Women who are pregnant or breastfeeding, and male or female subjects who plan to have children within 1 year after receiving MC-1-50 cell infusion;
- Other situations considered by the investigator to be unsuitable to participate in the study.
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
- Recruiting
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang
Jing Xue, M.D., +8613858121751, xuej@zju.edu.cn
- Recruiting
The First Affiliated Hospital of University of Science and Technology of China (Anhui Provincial Hospital)
Hefei, Anhui
Zhu Chen, M.D., +8613956963042, doczchen@gmail.com
About this study
Official title: Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)
This is a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
Read the detailed description
Based on the specific CD19-targeting CAR-T developed by PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs.At the same time, MC-1-50 products contain a high proportion of T naive cells, which can play a therapeutic role at a very low infusion dose and improve safety.
In this study, three dose groups were composed of 0.3×10^5/kg, 1×10^5/kg and 3×10^5/kg CAR-positive cells, respectively.All subjects received only one infusion of MC-1-50 cells.
- Conditions
- Systemic Lupus Erythematosus (SLE), Refractory
- Being tested
- MC-1-50
- Keywords
- CAR T-Cell therapy, Systemic Lupus Erythematosus
- 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.
MC-1-50Biological
A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| MC-1-50 | Experimental | Patients will be be treated with CD19 CAR- T cells Receives: Biological: MC-1-50 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Dose-limiting toxicity after CD19 CAR-T cell infusion
Measured: 1 month
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
Measured: 1 month
Secondary outcomes (6)
Validity endpoint of MC-1-50 cells [Efficacy]
3M SRI-4 response rate, 6M LLDAS, DORIS response rate，SLEDAI-2K score, PGA, and BILAG-2004 change from baseline
Measured: 3 months
AUCS of MC-1-50 cells [Cell dynamics]
AUCS is defined as the area under the curve in 28/90 days
Measured: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
CMAX is defined as the highest concentration of MC-1-50 cells expanded in peripheral blood
Measured: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
TMAX is defined as the time to reach the highest concentration
Measured: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
The clearance degree of CD19-positive B cells in peripheral blood was detected by flow cytometry at the visit points specified in the research protocol
Measured: 3 months
Immunogenicity of pCAR-19B cells
The anti-CAR antibody was detected by ELISAt the visit points specified in the research protocol
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 posted24 Mar 2025
- Study start12 Jun 2025
- Primary completion4 May 2026 (estimated)
- Study completion16 Feb 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 Erythematosus (SLE)Studies of the same condition, open and under way.
- More trials run by Chongqing Precision Biotech Co., LtdThe sponsor's other registered studies.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Chongqing Precision Biotech Co., Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06892145
- Sponsor's protocol ID
- PB13
- Status last verified
- Dec 2025
- First submitted
- 18 Mar 2025
- Last updated
- 22 Dec 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 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Trial of CD19-targeting Chimeric Antigen Receptor T Lymphocyte (MC-1-50) for the Treatment of Refractory Adult Systemic Lupus Erythematosus(SLE)
- ClinicalTrials.gov ID
- NCT06892145
- Acronym / sponsor ID
- PB13
- Conditions
- Systemic Lupus Erythematosus (SLE), Refractory
- Keywords
- CAR T-Cell therapy, Systemic Lupus Erythematosus
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 12 Jun 2025 (actual)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 16 Feb 2028 (estimated)
- First posted
- 24 Mar 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 a single-arm, open, dose-increasing and dose-expanding phase I clinical trial to investigate the safety, tolerability and cytodynamic characteristics of MC-1-50 cell preparation, and to preliminatively observe the efficacy of MC-1-50 cell preparation in patients with refractory SLE, and to explore the applicable dose regimen for phase II clinical trials.
Detailed description
Based on the specific CD19-targeting CAR-T developed by PrimeCARTM platform, the cell preparation time is about 3 days, which can greatly shorten the waiting time of patients, improve production efficiency and reduce production costs.At the same time, MC-1-50 products contain a high proportion of T naive cells, which can play a therapeutic role at a very low infusion dose and improve safety.
In this study, three dose groups were composed of 0.3×10^5/kg, 1×10^5/kg and 3×10^5/kg CAR-positive cells, respectively.All subjects received only one infusion of MC-1-50 cells.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MC-1-50 | Experimental | Biological: MC-1-50Patients will be be treated with CD19 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 (14 listed)
- The patient or their guardian agrees to participate in this clinical trial and sign the ICF, indicating their understanding of the purpose and procedures of this clinical trial and willingness to participate in the study;
- Age ≥ 18 years old , gender not limited;
- Patients diagnosed with SLE according to the 2019 EULAR/ACR classification criteria,And by hydroxychloroquine, sufficient glucocorticoid (≥1mg/kg/d prednisone or equivalent amount of other hormones), to less than 2Treatment with immunosuppressants (including cyclophosphamide, motecophanate, azathioprine, methotrexate, cyclosporine, tacrolimus, sirolimus, leflunomide, etc.), and at least one approved biological agent (including titacept, Beliuzumab, etc.), with a total duration of treatment ≥3 months, still in a disease active state, or unable to tolerate conventional therapy;
- SLEDAI-2K score ≥7 points;
- Autoantibody test results are positive: ANA antibody positive and/or serum anti-DSDNA positive;
Key exclusion criteria (20 listed)
- There were severe active central nervous system lupus that required therapeutic intervention at the time of screening;
- Acute severe nephritis: had or was undergoing renal replacement therapy within 3 months prior to reinfusion, or had significant renal deterioration that the investigator believed was likely to cause the subject to require high doses of corticosteroids (prednisone ≥1mg/kg/ day or equivalent of other hormones), cyclophosphamide, or mycophanate during the first 3 months of the study;Clinical stable lupus nephritis that can be controlled during screening can be considered;
- There were other lupus crises that were not controlled at the time of screening;
- Individuals who have received CAR-T therapy or other gene modified cell therapies;
- Combined with other autoimmune diseases requiring systemic treatment;
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 |
|---|---|---|
| MC-1-50A single infusion of CD19 CAR-T cells will be administered intravenously after lymphodepletion chemotherapy | Biological | MC-1-50 |
Primary outcome
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 month
Dose-limiting toxicity after CD19 CAR-T cell infusion
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
Time frame: 1 month
The incidence of adverse events after CAR-T cell infusion was assessed by the National Cancer Institute\'s Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)
6 secondary outcomes
Validity endpoint of MC-1-50 cells [Efficacy]
Time frame: 3 months
AUCS of MC-1-50 cells [Cell dynamics]
Time frame: 3 months
CMAX of MC-1-50 cell preparation [Cell dynamics]
Time frame: 3 months
TMAX of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
Pharmacodynamics of MC-1-50 cell preparation[Cell dynamics]
Time frame: 3 months
Immunogenicity of pCAR-19B cells
Time frame: 3 months
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 22 Dec 2025.
- Individual participant dataSharing planned: No
Related trials for Systemic Lupus Erythematosus (SLE)
Not yet recruitingPhase 1
An Ascending Dose Study of DKB903 in Participants With Rheumatoid Arthritis (RA) and Participants With Systemic Lupus Erythematosus (SLE)
Rheumatoid Arthritis and Systemic Lupus Erythematosus
RecruitingObservational study
Electroencephalogram Recording in Patients With Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
RecruitingPhase 1
A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
Rheumatoid Arthritis, Systemic Lupus Erythematosus
RecruitingPhase 1
To Evaluate the Effects of Cevostamab in Participants With Systemic Lupus Erythematosus With or Without Active Lupus Nephritis
Lupus Erythematosus, Systemic
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing MC-1-50 in people with Systemic Lupus Erythematosus (SLE) and Refractory, run by Chongqing Precision Biotech 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 14 inclusion and 20 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 22 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?
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 Jing Xue, M.D. (+8613858121751, xuej@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability] (time frame: 1 month). 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 22 Dec 2025.