Systemic Lupus ErythematosusPhase 1NCT07403097
Study of CD19 CAR-T Therapy for Refractory SLE
A Phase 1 study testing PTOC1 in people with Systemic Lupus Erythematosus, run by Chongqing Precision Biotech Co., Ltd at 1 site in China.
Trial summary
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 5 years and older
- Conditions the study is for
- Systemic Lupus Erythematosus
- What is being tested?
- PTOC1
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- Feb 2026to Dec 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 5 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age ≥ 5 years, no gender limitation;
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steroid), combined with hydroxychloroquine, and at least 2 Immunosuppressants or biologics (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) or intolerant to standard treatments;
- SLEDAI-2K score ≥ 8 points;
- The functions of vital organs must meet the following requirements:
- cardiac function: left ventricular ejection fraction (LVEF) ≥ 50%, with no obvious abnormalities on electrocardiogram (ECG);
- renal function: eGFR ≥ 30 mL/min/1.73m2;
Show all 11Show fewer
- hepatic function: AST and ALT ≤ 3.0×ULN, total bilirubin ≤ 2.0×ULN;
- pulmonary function: no severe pulmonary lesions; blood oxygen saturation ≥ 92% under non-oxygen supplementation conditions.
- Meet the criteria of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
- Negative pregnancy test for female subjects of childbearing age, and agree to take effective contraceptive measures until one year after infusion;
- Participant or his/her guardians agree to participate in the clinical trial and sign the informed consent form indicating that he/she understands the purpose and procedure of the clinical trial and is willing to participate in the study.
Who cannot join
- Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc;
- Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or patients with unstable vital signs who require vasopressors to maintain blood pressure;
- Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;
- Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA level exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum antibody;
- History of macrophage activation syndrome within 1 month prior to screening (except for those for whom the investigator has determined that safety risks are excluded after treatment);
Show all 13Show fewer
- History of previous CAR-T therapy (except for those for whom the investigator has determined that safety risks are excluded after treatment);
- Presence of active pulmonary tuberculosis at the time of screening;
- Having received any vaccination within 4 weeks prior to screening;
- Positive result of blood pregnancy test;
- A confirmed diagnosis of malignant diseases such as tumors prior to screening;
- Participation in other clinical trials within 3 months prior to enrollment;
- Other circumstances that the investigator deems inappropriate for participation 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, 1 recruiting
- Recruiting
Children's Hospital of Chongqing Medical University
Chongqing
Xiaodong Zhao, +8613896187845, zhaoxd530@aliyun.com
Yunfei An, +8618623070626, anyf82@aliyun.com
About this study
Official title: Study of Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus
This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
Read the detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients typically need to remain on medication indefinitely. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these treatments cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. In addition, discontinuing these drugs can lead to disease relapse, and patients still face the challenges of lifelong medication and an incurable disease.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition. Clinical studies have demonstrated that CD19-targeted CAR-T cells hold significant therapeutic potential for SLE. Compared with traditional CAR-T cells, PTOC1 cells Injection, relying on an innovative CAR-T manufacturing system, can be produced in an extremely short period of time (with a preparation time of only 10 minutes).
The purpose of this study is to assess the safety and efficacy of PTOC1 cells Injection in the treatment of refractory SLE.
- Conditions
- Systemic Lupus Erythematosus
- Being tested
- PTOC1
- Keywords
- CD19, CAR-T
- 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.
PTOC1Biological
Three dose groups (1.5×10^5/kg, 5×10^5/kg,1×10^6/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
| Study group | Role | What they receive |
|---|---|---|
| PTOC1 | Experimental | This trial was designed as an open, single-arm, single-center, dose-exploration trial. Receives: Biological: PTOC1 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of PTOC1 cell therapy in patients with refractory SLE [Safety]
Types, frequency and severity of adverse events.
Measured: 3 months
The changes in SLEDAI-2K from baseline [efficacy]
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ranges from 0 to 105 points. The higher the score, the higher the disease activity.
Measured: 6 months
The changes in PGA from baseline [efficacy]
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scores. "0" indicates no disease activity and "3" indicates the most severe disease activity.
Measured: 6 months
The changes in BILAG-2004 from baseline [efficacy]
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is graded as A, B, C and D. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is uninvolved.
Measured: 6 months
The number of patients with SRI-4 response [efficacy]
The definition of SRI-4 response: SLEDAI-2K ≥ 4 points improvement; PGA <0.3 points increase; BILAG 2004 with no new A grade score and no more than 1 new B grade score.
Measured: 3 months
The number of patients with LLDAS [efficacy]
The definition of LLDAS: SLEDAI-2K ≤ 4 points and no disease activity in major organs (kidney, central nervous system, heart and lung), and no vasculitis or fever; no new disease activity symptoms compared with previous disease assessments; PGA ≤ 1; serological parameters not required; with the permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
Measured: 6 months
The number of patients with DORIS [efficacy]
The definition of DORIS: SLEDAI-2K = 0 points; PGA < 0.5 points; serological parameters not required; with the permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
Measured: 6 months
Secondary outcomes (9)
Cmax of PTOC1 cells [PK parameter]
The peak concentration (Cmax) of amplified PTOC1 cells in peripheral blood after infusion can be measured.
Measured: 3 months
Tmax of PTOC1 cells [PK parameter]
The time for amplified PTOC1 cells in peripheral blood to reach the maximum concentration (Tmax) can be measured.
Measured: 3 months
AUC28d/90d of PTOC1 cells [PK parameter]
The area under the plasma concentration-time curve from 28 to 90 days after infusion (AUC28d/90d) can be measured.
Measured: 3 months
The degree of B cell depletion [PD parameter]
The degree of CD19+ B cell depletion at different time points.
Measured: 3 months
The concentration of IL-6 [PD parameter]
The serum concentration of CAR-T therapy-related cytokines such as IL-6 at different time points.
Measured: 3 months
The concentration of CRP [PD parameter]
The serum concentration of CAR-T therapy-related cytokines such as CRP at different time points.
Measured: 3 months
The concentration of ferritin [PD parameter]
The serum concentration of CAR-T therapy-related cytokines such as ferritin at different time points.
Measured: 3 months
The proportion of major B-cell subtypes
The proportion of major B-cell subtypes at each visit time point after infusion.
Measured: 6 months
The correlation between the proportion of major B-cell subtypes and the reduction of disease activity
The correlation between the proportion of major B-cell subtypes at each visit time point after infusion and the reduction of disease activity relative to baseline.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2026
- Study startFeb 2026 (estimated)
- Primary completionApr 2028 (estimated)
- Study completionDec 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.
- 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
- 18 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
- NCT07403097
- Sponsor's protocol ID
- PBC098
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 11 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Autologous CD19-Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT07403097
- Acronym / sponsor ID
- PBC098
- Conditions
- Systemic Lupus Erythematosus
- Keywords
- CD19, CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Chongqing Precision Biotech Co., LtdIndustry (pharma, biotech, devices)
- Study start
- Feb 2026 (estimated)
- Primary completion
- Apr 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 11 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 aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.
Detailed description
Systemic lupus erythematosus (SLE) is a serious autoimmune disease that can lead to extensive damage in multiple organs and systems, ultimately resulting in disability and even death.
Currently, the primary treatment for SLE relies on glucocorticoids and immunosuppressants to alleviate symptoms. However, due to the absence of a curative treatment, patients typically need to remain on medication indefinitely. In recent years, biological agents such as belimumab and rituximab have been introduced for the treatment of SLE, but these treatments cannot completely eliminate autoimmune B cells in the bone marrow, leading to unsatisfactory overall outcomes. In addition, discontinuing these drugs can lead to disease relapse, and patients still face the challenges of lifelong medication and an incurable disease.
CAR-T therapy is an adoptive cell therapy that uses genetic modification technology to reprogram T cells and eliminate target cells expressing disease-related antigens through antigen-specific recognition. Clinical studies have demonstrated that CD19-targeted CAR-T cells hold significant therapeutic potential for SLE. Compared with traditional CAR-T cells, PTOC1 cells Injection, relying on an innovative CAR-T manufacturing system, can be produced in an extremely short period of time (with a preparation time of only 10 minutes).
The purpose of this study is to assess the safety and efficacy of PTOC1 cells Injection in the treatment of refractory SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| PTOC1 | Experimental | Biological: PTOC1This trial was designed as an open, single-arm, single-center, dose-exploration trial. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (11 listed)
- Age ≥ 5 years, no gender limitation;
- Diagnosed with SLE according to the 2019 EULAR/ACR classification criteria, and still in moderate to severe disease activity despite ≥ 3 months of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steroid), combined with hydroxychloroquine, and at least 2 Immunosuppressants or biologics (including cyclophosphamide, mycophenolate mofetil, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, belimumab, and rituximab) or intolerant to standard treatments;
- SLEDAI-2K score ≥ 8 points;
- The functions of vital organs must meet the following requirements:
- Meet the criteria of leukapheresis or intravenous blood collection, and no contraindication for leukapheresis;
Key exclusion criteria (13 listed)
- Central nervous system (CNS) diseases: presence of CNS lupus symptoms requiring intervention within 60 days, including epilepsy, confusion, cerebrovascular events, etc;
- Congenital heart disease or severe arrhythmia before screening: Including multifocal and frequent supraventricular tachycardia, ventricular tachycardia, etc.; or complicated with moderate to large pericardial effusion, severe myocarditis, etc.; or patients with unstable vital signs who require vasopressors to maintain blood pressure;
- Presence of active infections requiring systemic treatment or uncontrolled infections within 3 months prior to screening;
- Having received solid organ transplantation or hematopoietic stem cell transplantation within 3 months prior to screening; or having grade 2 or above acute graft-versus-host disease (GVHD) within 2 weeks prior to screening;
- Positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood hepatitis B virus (HBV) DNA level exceeding the normal range; positive for hepatitis C virus (HCV) antibody with peripheral blood hepatitis C virus (HCV) RNA level exceeding the normal range; positive for human immunodeficiency virus (HIV) antibody; positive for treponema pallidum antibody;
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 |
|---|---|---|
| PTOC1Three dose groups (1.5×10^5/kg, 5×10^5/kg,1×10^6/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. | Biological | PTOC1 |
Primary outcome
The safety of PTOC1 cell therapy in patients with refractory SLE [Safety]
Time frame: 3 months
Types, frequency and severity of adverse events.
The changes in SLEDAI-2K from baseline [efficacy]
Time frame: 6 months
Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) ranges from 0 to 105 points. The higher the score, the higher the disease activity.
The changes in PGA from baseline [efficacy]
Time frame: 6 months
Physician Global Assessment(PGA) is a continuous visual analogue scale with 0, 1, 2, and 3 scores. "0" indicates no disease activity and "3" indicates the most severe disease activity.
The changes in BILAG-2004 from baseline [efficacy]
Time frame: 6 months
British Isles Lupus Assessment Group Index 2004(BILAG-2004) consists of 8 systems, each of which is graded as A, B, C and D. "A" indicates that the condition is highly active and requires active treatment. "B" indicates that the condition is active and requires close monitoring or symptomatic treatment. "C" indicates a stable condition. "D" indicates that the system is uninvolved.
The number of patients with SRI-4 response [efficacy]
Time frame: 3 months
The definition of SRI-4 response: SLEDAI-2K ≥ 4 points improvement; PGA <0.3 points increase; BILAG 2004 with no new A grade score and no more than 1 new B grade score.
The number of patients with LLDAS [efficacy]
Time frame: 6 months
The definition of LLDAS: SLEDAI-2K ≤ 4 points and no disease activity in major organs (kidney, central nervous system, heart and lung), and no vasculitis or fever; no new disease activity symptoms compared with previous disease assessments; PGA ≤ 1; serological parameters not required; with the permitted use of low-dose glucocorticoids (prednisolone ≤ 7.5 mg/day), and/or stable immunosuppressives and biologics.
The number of patients with DORIS [efficacy]
Time frame: 6 months
The definition of DORIS: SLEDAI-2K = 0 points; PGA < 0.5 points; serological parameters not required; with the permitted use of antimalarials, low-dose glucocorticoids (prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
9 secondary outcomes
Cmax of PTOC1 cells [PK parameter]
Time frame: 3 months
Tmax of PTOC1 cells [PK parameter]
Time frame: 3 months
AUC28d/90d of PTOC1 cells [PK parameter]
Time frame: 3 months
The degree of B cell depletion [PD parameter]
Time frame: 3 months
The concentration of IL-6 [PD parameter]
Time frame: 3 months
The concentration of CRP [PD parameter]
Time frame: 3 months
The concentration of ferritin [PD parameter]
Time frame: 3 months
The proportion of major B-cell subtypes
Time frame: 6 months
The correlation between the proportion of major B-cell subtypes and the reduction of disease activity
Time frame: 6 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 11 Feb 2026.
Related trials for Systemic Lupus Erythematosus
Active, not recruitingPhase 2
A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Phase 2a Study With an Open-Label Extension Evaluating the Efficacy and Safety of VENT-03 in Adult Participants With Active Cutaneous Lupus Erythematosus With or Without Systemic Lupus Erythematosus
Cutaneous Lupus Erythematosus (CLE), Systemic Lupus Erythematosus
RecruitingPhase 1
A Clinical Study of MK-1045 in People With Lupus or Rheumatoid Arthritis (MK-1045-004)
Systemic Lupus Erythematosus, Rheumatoid Arthritis
RecruitingPhase 3
A Study to Evaluate the Efficacy and Safety of Dapirolizumab Pegol in Study Participants With Moderately to Severely Active Systemic Lupus Erythematosus
Systemic Lupus Erythematosus
RecruitingPhase 1
A Study to Investigate the Safety and Preliminary Efficacy of ALLO-329, an Allogeneic CAR T-cell Therapy, in Adults With Autoimmune Disease
Systemic Lupus Erythematosus (With and Without Nephritis), Idiopathic Inflammatory Myopathy
RecruitingObservational study
Deciphering the Genetic Architecture of Autoimmune Diseases
Autoimmune Diseases
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 PTOC1 in people with Systemic Lupus Erythematosus, run by Chongqing Precision Biotech 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 13 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 11 Feb 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?
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 Xiaodong Zhao (+8613896187845, zhaoxd530@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of PTOC1 cell therapy in patients with refractory SLE [Safety] (time frame: 3 months). The study lists 7 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 11 Feb 2026.