CAR T Cell TherapyPhase 1NCT06934447
Study of BCMA/CD70 CAR-T Therapy for Refractory cSLE
A Phase 1 study testing anti-BCMA/CD70-CAR-T cells in people with CAR T Cell Therapy and Systemic Lupus Erythematosus, run by The Children's Hospital of Zhejiang University School of Medicine at 1 site in China.
Trial summary
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells 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
- CAR T Cell Therapy, Systemic Lupus Erythematosus, BCMA
- What is being tested?
- anti-BCMA/CD70-CAR-T cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteChina
- Study dates
- 25 Apr 2025to 1 Apr 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 old;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab); or Intolerant to standard treatments;
- SLEDAI 2K score≥8 points;
- The functions of important organs are as follows: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2；Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No serious lung lesions, SpO2≥92%;
- No prior CAR-T therapy; or recurrence or poor response after previous treatment with autologous or allogeneic CAR-T targeting CD19 (as assessed by the investigator).
- Met the standards of leukapheresis or intravenous blood collection, No contraindication for cell collection;
- Negative pregnancy test for female Subjects of childbearing age, agree to take effective contraceptive measures the first year after CAR-T infusion;
- Participants or their guardians agrees to participate in the clinical trial and sign the informed consent form which 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) disease: CNS neurolupus requires intervention within 60 days);
- Severe acute nephritis: Patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; Or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or MMF treatment;
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；
- Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
- Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
- History of organ transplantation or hematopoietic stem cell transplantation, or ≥Grade 2 GVHD within 2 weeks prior to screening；
Show all 11Show fewer
- Hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) positive and peripheral blood hepatitis B virus (HBV) DNA titer greater than the normal reference value range; Or hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA titer greater than the normal reference value range; Or positive for human immunodeficiency virus (HIV) antibodies; Or syphilis test positive; Or cytomegalovirus (CMV) DNA test positive;
- Received live vaccine within 4 weeks before screening;
- Tested positive in Blood pregnancy test；
- Previous or concurrent malignancy；
- Patients who participated in other clinical study within 1 months prior to enrollment; Any other conditions that the investigators deem it unsuitable for the 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
hildren's Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310052
Jianhua Mao, Prof, 0571-56555983, maojh88@zju.edu.cn
Xue He, 15088688407, hexue1119@163.com
About this study
Official title: Study of BCMA/CD70 Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Childhood-oneset Systemic Lupus Erythematosus
This is an investigator-initiated trial aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Read the detailed description
Systemic lupus erythematosus (SLE) is a severe autoimmune disease that can lead to extensive damage in multiple organs and systems, potentially leading to disability and even mortality. Children afflicted with SLE are particularly vulnerable to organ damage, notably affecting the kidneys, and tend to have a more severe and protracted course of the disease compared to adults.
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. Furthermore, discontinuing these drugs can lead to disease relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease. BCMA (B Cell Maturation Antigen) is a receptor primarily expressed on the surface of mature B lymphocytes and plasma cells, serving as a marker protein for B lymphocyte maturation. B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are the main ligands of BCMA. They interact with BCMA to transmit cellular stimulatory signals, activating TRAF-dependent NF-κB and JNK pathways, thereby increasing the proliferation and survival rate of B cells. Importantly, BCMA is highly expressed in long-lived plasma cells,8 which do not express CD19. Therefore, BCMA can compensate for the targeting defect of CD19's insufficient expression in terminally differentiated plasma cells. CD70 is an immune costimulatory molecule for T and B cells, highly expressed on the surface of activated T cells. The CD70/CD27 pathway regulates immunity and tolerance through various mechanisms, including T-cell expansion and survival, costimulation of antigen presentation, germinal center formation, B-cell activation, and antibody production. It plays a crucial role in the differentiation of B cells into plasma cells. Blocking the CD27/CD70 pathway can inhibit the differentiation of memory B cells into plasma cells. Studies have found that CD70 is overexpressed in B cells of SLE patients compared to healthy individuals.
The purpose of this study is to assess the safety and efficacy of the BCMA/CD70 CAR-T cells in the treatment of refractory SLE.
- Conditions
- CAR T Cell Therapy, Systemic Lupus Erythematosus, BCMA
- Being tested
- anti-BCMA/CD70-CAR-T cells
- Keywords
- systemic lupus erythematosus, Chimeric antigen receptor (CAR) T-cell, BCMA
- 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.
anti-BCMA/CD70-CAR-T cellsBiological
Three dose groups (0.3×105/kg, 1×105/kg, 3×105/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.
| Study group | Role | What they receive |
|---|---|---|
| CAR-T treatment group | Experimental | This trial was designed as an open, single-arm, multicenter, dose-increasing trial. Receives: Biological: anti-BCMA/CD70-CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
The safety of BCMA/CD70 CAR-T cell therapy in patients with refractory SLE
Incidence and severity of AEs and SAEs,including changes in laboratory values, Electrocardiograph(ECG) and vital signs assessed by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0.
Measured: 3 months
The efficiency of CAR-T cell therapy in patients with refractory SLE
Number of patients with SRI-4 response:including SLEDAI-2K ≥ 4-Point improvement, PGA with no worsening (\&amp;amp;lt;0.3-point increase), BILAG 2004 with no new A domain score and no more than 1 new B domain scores. Number of patients with DORIS: including SLEDAI-2K = 0 and a Physician's Global Assessment (PGA) < 0.5, irrespective of serology, with permitted use of antimalarials, low-dose glucocorticoids (GCs; prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
Measured: 6 months
Secondary outcomes (4)
Cellular kinetics
CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood.
Measured: 6 months
Autoantibody detection
Autoantibody detection up after BCMA/CD70 CAR-T cells infusion.
Measured: 24 months
Pharmacokinetic Outcome AUC
The area under the curve (AUC) at 28 days and 90 days post-infusion (AUC28d/90d)
Measured: 3 months
Duration of disease response (DOR)
The time between the first investigator assessment of remission and the first investigator assessment of progression or death from any cause.
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start25 Apr 2025 (estimated)
- Primary completion1 Apr 2028 (estimated)
- Study completion1 Apr 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (7)Papers the sponsor has linked to this study.
- Other trials for CAR T Cell TherapyStudies 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
- Model description
- Treatment of pediatric patients with refractory systemic lupus erythematosus using BMCA/CD70-targeted CAR T cells
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- The Children's Hospital of Zhejiang University School of Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Responsible party
- Principal investigator, Mao Jianhua, The Children's Hospital of Zhejiang University School of Medicine
- Investigators
- Jianhua Mao, MD, Principal investigator, The Children's Hospital of Zhejiang University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06934447
- Sponsor's protocol ID
- PBC088
- Status last verified
- Apr 2025
- First submitted
- 11 Apr 2025
- Last updated
- 25 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.
PubMed 36109639Charras A, Smith E, Hedrich CM. Systemic Lupus Erythematosus in Children and Young People. Curr Rheumatol Rep. 2021 Feb 10;23(3):20. doi: 10.1007/s11926-021-00985-0.
PubMed 33569643Accapezzato D, Caccavale R, Paroli MP, Gioia C, Nguyen BL, Spadea L, Paroli M. Advances in the Pathogenesis and Treatment of Systemic Lupus Erythematosus. Int J Mol Sci. 2023 Mar 31;24(7):6578. doi: 10.3390/ijms24076578.
PubMed 37047548Schett G, Muller F, Taubmann J, Mackensen A, Wang W, Furie RA, Gold R, Haghikia A, Merkel PA, Caricchio R, D'Agostino MA, Locatelli F, June CH, Mougiakakos D. Advancements and challenges in CAR T cell therapy in autoimmune diseases. Nat Rev Rheumatol. 2024 Sep;20(9):531-544. doi: 10.1038/s41584-024-01139-z. Epub 2024 Aug 6.
PubMed 39107407Winter O, Dame C, Jundt F, Hiepe F. Pathogenic long-lived plasma cells and their survival niches in autoimmunity, malignancy, and allergy. J Immunol. 2012 Dec 1;189(11):5105-11. doi: 10.4049/jimmunol.1202317.
PubMed 23169863Liu Q, Deng Y, Liu X, Zheng Y, Li Q, Cai G, Feng Z, Chen X. Transcriptomic analysis of B cells suggests that CD70 and LY9 may be novel features in patients with systemic lupus erythematosus. Heliyon. 2023 Apr 23;9(5):e15684. doi: 10.1016/j.heliyon.2023.e15684. eCollection 2023 May.
PubMed 37144201Wang W, He S, Zhang W, Zhang H, DeStefano VM, Wada M, Pinz K, Deener G, Shah D, Hagag N, Wang M, Hong M, Zeng R, Lan T, Ma Y, Li F, Liang Y, Guo Z, Zou C, Wang M, Ding L, Ma Y, Yuan Y. BCMA-CD19 compound CAR T cells for systemic lupus erythematosus: a phase 1 open-label clinical trial. Ann Rheum Dis. 2024 Sep 30;83(10):1304-1314. doi: 10.1136/ard-2024-225785.
PubMed 38777376
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of BCMA/CD70 Targeted Chimeric Antigen Receptor T (CAR- T) Therapy for Refractory Childhood-oneset Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06934447
- Acronym / sponsor ID
- PBC088
- Conditions
- CAR T Cell Therapy, Systemic Lupus Erythematosus, BCMA
- Keywords
- systemic lupus erythematosus, Chimeric antigen receptor (CAR) T-cell, BCMA
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- The Children's Hospital of Zhejiang University School of MedicineUniversity, hospital or other
- Collaborators
- Chongqing Precision Biotech Co., Ltd
- Study start
- 25 Apr 2025 (estimated)
- Primary completion
- 1 Apr 2028 (estimated)
- Study completion
- 1 Apr 2028 (estimated)
- First posted
- 18 Apr 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 aimed at assessing the safety and efficacy of anti-BCMA/CD70 CAR-T cells in the treatment of refractory systemic lupus erythematosus.
Detailed description
Systemic lupus erythematosus (SLE) is a severe autoimmune disease that can lead to extensive damage in multiple organs and systems, potentially leading to disability and even mortality. Children afflicted with SLE are particularly vulnerable to organ damage, notably affecting the kidneys, and tend to have a more severe and protracted course of the disease compared to adults.
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. Furthermore, discontinuing these drugs can lead to disease relapse, and there is still no cure for SLE, leaving patients facing the challenges of lifelong medication and an incurable disease. BCMA (B Cell Maturation Antigen) is a receptor primarily expressed on the surface of mature B lymphocytes and plasma cells, serving as a marker protein for B lymphocyte maturation. B-cell activating factor (BAFF) and a proliferation-inducing ligand (APRIL) are the main ligands of BCMA. They interact with BCMA to transmit cellular stimulatory signals, activating TRAF-dependent NF-κB and JNK pathways, thereby increasing the proliferation and survival rate of B cells. Importantly, BCMA is highly expressed in long-lived plasma cells,8 which do not express CD19. Therefore, BCMA can compensate for the targeting defect of CD19's insufficient expression in terminally differentiated plasma cells. CD70 is an immune costimulatory molecule for T and B cells, highly expressed on the surface of activated T cells. The CD70/CD27 pathway regulates immunity and tolerance through various mechanisms, including T-cell expansion and survival, costimulation of antigen presentation, germinal center formation, B-cell activation, and antibody production. It plays a crucial role in the differentiation of B cells into plasma cells. Blocking the CD27/CD70 pathway can inhibit the differentiation of memory B cells into plasma cells. Studies have found that CD70 is overexpressed in B cells of SLE patients compared to healthy individuals.
The purpose of this study is to assess the safety and efficacy of the BCMA/CD70 CAR-T cells 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
- Model description
- Treatment of pediatric patients with refractory systemic lupus erythematosus using BMCA/CD70-targeted CAR T cells
| Arm | Type | Receives |
|---|---|---|
| CAR-T treatment group | Experimental | Biological: anti-BCMA/CD70-CAR-T cellsThis trial was designed as an open, single-arm, multicenter, dose-increasing trial. |
Who may qualify
- Ages
- 5 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (8 listed)
- Age:≥5 years old;
- Diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria；Still in moderate to severe disease activity despite ≥3M of high dose glucocorticoids(prednisone≥1mg/kg/d or other equivalent amount of other steriod ), hydroxychloroquine and at least 2 of the following treatments(cyclophosphamide, MMF, azathioprine, methotrexate, cyclosporin, tacrolimus, sirolimus, leflunomide, telitacicept, Beliumab, and rituximab); or Intolerant to standard treatments;
- SLEDAI 2K score≥8 points;
- The functions of important organs are as follows: Cardiac function: Left ventricular ejection fraction (LVEF) ≥55% with no obvious abnormality in electrocardiogram; Renal function: eGFR≥30ML/min/1.73m2；Liver function: Asparagus cochinchinensis transase (AST) and Alanine Aminotransferase (ALT)≤3.0 ULN, Total Bilirubin (TBIL) in serum ≤2.0×ULN; Lung function: No serious lung lesions, SpO2≥92%;
- No prior CAR-T therapy; or recurrence or poor response after previous treatment with autologous or allogeneic CAR-T targeting CD19 (as assessed by the investigator).
Key exclusion criteria (11 listed)
- Central nervous system (CNS) disease: CNS neurolupus requires intervention within 60 days);
- Severe acute nephritis: Patients who have accepted or was undergoing renal replacement therapy within 3 months prior to transfusion; Or in the investgator's opinion, patients who is likely to have significant kidney disease within 3 moths of the study which need high dose glucocorticoid (prednisone dose≥1mg/kg/day or equivalent amount of other steriod), cyclophosphamide, or MMF treatment;
- Have a history of congenital heart disease or acute myocardial infarction within 6 months prior to screening; Or severe arrhythmias (including multisource frequent supraventricular tachycardia, ventricular tachycardia, etc.); Or combined with moderate to massive pericardial effusion, serious myocarditis, etc; Or patients with unstable vital signs who need hypertensive drugs；
- Suffer from other diseases that require long-term use of glucocorticoid or high-dose of immunosuppressive agents;
- Uncontrollable infection, or active infection that requires systemic treatment within 1 week prior to screening；
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 |
|---|---|---|
| anti-BCMA/CD70-CAR-T cellsThree dose groups (0.3×105/kg, 1×105/kg, 3×105/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose. | Biological | CAR-T treatment group |
Primary outcome
The safety of BCMA/CD70 CAR-T cell therapy in patients with refractory SLE
Time frame: 3 months
Incidence and severity of AEs and SAEs,including changes in laboratory values, Electrocardiograph(ECG) and vital signs assessed by CommonTerminology Criteria for Adverse Events (CTCAE) v5.0.
The efficiency of CAR-T cell therapy in patients with refractory SLE
Time frame: 6 months
Number of patients with SRI-4 response:including SLEDAI-2K ≥ 4-Point improvement, PGA with no worsening (\&amp;amp;lt;0.3-point increase), BILAG 2004 with no new A domain score and no more than 1 new B domain scores. Number of patients with DORIS: including SLEDAI-2K = 0 and a Physician's Global Assessment (PGA) < 0.5, irrespective of serology, with permitted use of antimalarials, low-dose glucocorticoids (GCs; prednisolone ≤ 5 mg/day), and/or stable immunosuppressives and biologics.
4 secondary outcomes
Cellular kinetics
Time frame: 6 months
Autoantibody detection
Time frame: 24 months
Pharmacokinetic Outcome AUC
Time frame: 3 months
Duration of disease response (DOR)
Time frame: 24 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 25 Apr 2025.
- Background: PubMed 36109639Mackensen A, Muller F, Mougiakakos D, Boltz S, Wilhelm A, Aigner M, Volkl S, Simon D, Kleyer A, Munoz L, Kretschmann S, Kharboutli S, Gary R, Reimann H, Rosler W, Uderhardt S, Bang H, Herrmann M, Ekici AB, Buettner C, Habenicht KM, Winkler TH, Kronke G, Schett G. Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus. Nat Med. 2022 Oct;28(10):2124-2132. doi: 10.1038/s41591-022-02017-5. Epub 2022 Sep 15.
- Background: PubMed 33569643Charras A, Smith E, Hedrich CM. Systemic Lupus Erythematosus in Children and Young People. Curr Rheumatol Rep. 2021 Feb 10;23(3):20. doi: 10.1007/s11926-021-00985-0.
- Background: PubMed 37047548Accapezzato D, Caccavale R, Paroli MP, Gioia C, Nguyen BL, Spadea L, Paroli M. Advances in the Pathogenesis and Treatment of Systemic Lupus Erythematosus. Int J Mol Sci. 2023 Mar 31;24(7):6578. doi: 10.3390/ijms24076578.
- Background: PubMed 39107407Schett G, Muller F, Taubmann J, Mackensen A, Wang W, Furie RA, Gold R, Haghikia A, Merkel PA, Caricchio R, D'Agostino MA, Locatelli F, June CH, Mougiakakos D. Advancements and challenges in CAR T cell therapy in autoimmune diseases. Nat Rev Rheumatol. 2024 Sep;20(9):531-544. doi: 10.1038/s41584-024-01139-z. Epub 2024 Aug 6.
- Background: PubMed 23169863Winter O, Dame C, Jundt F, Hiepe F. Pathogenic long-lived plasma cells and their survival niches in autoimmunity, malignancy, and allergy. J Immunol. 2012 Dec 1;189(11):5105-11. doi: 10.4049/jimmunol.1202317.
- Background: PubMed 37144201Liu Q, Deng Y, Liu X, Zheng Y, Li Q, Cai G, Feng Z, Chen X. Transcriptomic analysis of B cells suggests that CD70 and LY9 may be novel features in patients with systemic lupus erythematosus. Heliyon. 2023 Apr 23;9(5):e15684. doi: 10.1016/j.heliyon.2023.e15684. eCollection 2023 May.
- Background: PubMed 38777376Wang W, He S, Zhang W, Zhang H, DeStefano VM, Wada M, Pinz K, Deener G, Shah D, Hagag N, Wang M, Hong M, Zeng R, Lan T, Ma Y, Li F, Liang Y, Guo Z, Zou C, Wang M, Ding L, Ma Y, Yuan Y. BCMA-CD19 compound CAR T cells for systemic lupus erythematosus: a phase 1 open-label clinical trial. Ann Rheum Dis. 2024 Sep 30;83(10):1304-1314. doi: 10.1136/ard-2024-225785.
- BCMA-CD19 compound CAR T cells for systemic lupus erythematosus: a phase 1 open-label clinical trial.Link provided by the sponsor.
- Transcriptomic analysis of B cells suggests that CD70 and LY9 may be novel features in patients with systemic lupus erythematosus.Link provided by the sponsor.
- Anti-CD19 CAR T cell therapy for refractory systemic lupus erythematosus.Link provided by the sponsor.
- Systemic Lupus Erythematosus in Children and Young People.Link provided by the sponsor.
- Advances in the Pathogenesis and Treatment of Systemic Lupus ErythematosusLink provided by the sponsor.
- Pathogenic long-lived plasma cells and their survival niches in autoimmunity, malignancy, and allergy.Link provided by the sponsor.
- 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.
Jianhua Mao, MD principal investigator
The Children's Hospital of Zhejiang University School of Medicine
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 anti-BCMA/CD70-CAR-T cells in people with CAR T Cell Therapy and Systemic Lupus Erythematosus, run by The Children's Hospital of Zhejiang University School of Medicine 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 8 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 25 Apr 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 Jianhua Mao, MD (13516819071, maojh88@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The safety of BCMA/CD70 CAR-T cell therapy in patients with refractory SLE (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 NCT06934447, which also lists 7 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 25 Apr 2025.