Systemic Lupus ErythematosusNCT07517536
CHT105 for the Treatment of Refractory Lupus Nephritis
A study testing anti-CD19/70 CAR T cells (CHT105) in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School at 1 site in China.
Trial summary
Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China. The kidneys are the organ most frequently affected in SLE and a major cause of mortality among SLE patients. Currently, cell-based therapy has emerged as an innovative treatment approach for SLE. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis
- What is being tested?
- anti-CD19/70 CAR T cells (CHT105)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- 1 siteChina
- Study dates
- 22 Apr 2026to Jan 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years (inclusive), regardless of sex;
- Meets at least four of the 11 SLE classification criteria recommended by the American College of Rheumatology (ACR) in 1997; or fulfills the 2019 European League Against Rheumatism (EULAR)/ACR classification criteria for SLE;
- Diagnosed with active, biopsy-confirmed lupus nephritis (LN) class III or IV, with or without concurrent class V, according to the 2018 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification; renal biopsy must have been performed within one year prior to screening or during the screening period;
- Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urinary sediment featuring red blood cell casts;
- Moderate-to-severe disease activity, as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6;
- At least one British Isles Lupus Assessment Group (BILAG-2004) A-grade (severe) organ domain score, or two B-grade (moderate) organ domain scores, or a combination thereof;
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- Positive expression of CD19 and CD70 on peripheral blood B cells, as confirmed by flow cytometry;
- Refractory disease is defined as either failure to respond after ≥6 months of conventional therapy or recurrence of disease activity following prior remission. Conventional therapy includes glucocorticoids ± antimalarials, combined or sequentially administered with one or more of the following immunosuppressants: azathioprine, mycophenolate mofetil, cyclophosphamide, methotrexate, leflunomide, thalidomide, tripterygium wilfordii, tacrolimus, cyclosporine A, sirolimus, voclosporin, JAK inhibitors (including those targeting JAK1/2/3 and TYK2), and biologics such as, but not limited to, anti-CD20 monoclonal antibodies, belimumab, and telitacicept;
- Female participants of childbearing potential and male participants whose partners are of childbearing potential must use medically approved contraceptive methods or abstain from sexual intercourse throughout the study treatment period and for at least six months thereafter; female participants of childbearing potential must have a negative serum human chorionic gonadotropin (hCG) test within seven days prior to enrollment and must not be breastfeeding;
- Voluntarily participates in this clinical study, provides written informed consent, demonstrates good adherence, and agrees to comply with follow-up requirements.
Who cannot join
- Individuals with a history of severe drug allergy or allergic constitution;
- Presence of, or suspicion of, uncontrolled fungal, bacterial, viral, or other infections requiring hospitalization or intravenous therapy within one month prior to baseline;
- Any of the following cardiovascular or cerebrovascular events within six months prior to screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic coronary angiography is permitted), moderate-to-severe congestive heart failure (NYHA Class III or IV), atrial or ventricular arrhythmias requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia), implantation of a pacemaker or defibrillator, cerebrovascular accident (e.g., stroke), or planned coronary artery bypass surgery or vascular reconstruction during the trial;
- Participants with congenital immunoglobulin deficiency;
- History of malignancy within the past five years (except for basal cell carcinoma, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ, or thyroid carcinoma, all of which must have been definitively cured for at least one year);
- Participants with end-stage renal failure;
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- Active tuberculosis risk at screening, regardless of whether adequate treatment has been completed-including signs or symptoms of active tuberculosis as judged by the investigator at screening (e.g., fever, cough, night sweats, weight loss); or evidence of active pulmonary tuberculosis on chest imaging (e.g., chest X-ray or chest CT scan) performed at screening or at any time within six months prior to screening;
- Participants who are positive for hepatitis B surface antigen (HBsAg) and hepatitis B core antibody (HBcAb), with peripheral blood HBV DNA levels exceeding the upper limit of quantification; participants who are positive for hepatitis C virus (HCV) antibody and peripheral blood HCV RNA; participants who are positive for human immunodeficiency virus (HIV) antibody; or participants with a positive syphilis test;
- At screening, organ function must meet the following criteria:
- Bone marrow function: i. Absolute neutrophil count < 0.8 × 10⁹/L (within two weeks prior to assessment, without administration of colony-stimulating factors, except in cases attributable to SLE); ii. Hemoglobin < 60 g/L (except in cases attributable to SLE); b) Hepatic function: ALT > 3 × ULN; AST > 3 × ULN; total bilirubin (TBIL) > 1.5 × ULN; c) Renal function: creatinine clearance (CrCl) < 30 mL/min (calculated using the Cockcroft-Gault formula, except in cases attributable to SLE); d) Coagulation function: international normalized ratio (INR) > 1.5 × ULN or prothrombin time (PT) > 1.5 × ULN;
- Presence of psychiatric disorders or severe cognitive impairment (excluding neuropsychiatric SLE);
- Participation in another clinical trial within one month prior to enrollment;
- Pregnant women or women planning pregnancy;
- Participants deemed ineligible for this study by the investigator for any other reason.
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
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
Nanjing, Jiangsu, 210008
About this study
Official title: A Clinical Study to Evaluate the Safety and Efficacy of CHT105, an Allogeneic CAR-T Cell Injection Targeting CD19 and CD70, in Patients With Refractory Lupus Nephritis
Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China. The kidneys are the organ most frequently affected in SLE and a major cause of mortality among SLE patients. Currently, cell-based therapy has emerged as an innovative treatment approach for SLE. CHT105 injection is an allogeneic chimeric antigen receptor T (CAR-T) cell product derived from healthy donors' T cells, which are transduced with a lentiviral vector encoding an anti-CD19/CD70 CAR. This engineered T-cell product effectively recognizes and eliminates immune cells expressing CD19 and/or CD70 antigens-including autoreactive T and B cells-and holds promise as a novel therapeutic option for patients with refractory lupus nephritis (LN).
This study is a clinical trial evaluating the safety and preliminary efficacy of CHT105 injection-a CD19/CD70-targeting allogeneic CAR-T cell product-in adult patients with relapsed or refractory LN. Eligible participants will first undergo lymphodepleting preconditioning. Following confirmation of eligibility per standard infusion criteria, participants will receive a single intravenous infusion of CHT105 on Day 0 (D0). After CHT105 infusion, participants will undergo a 52-week short-term follow-up and up to a 15-year long-term follow-up.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Being tested
- anti-CD19/70 CAR T cells (CHT105)
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
anti-CD19/70 CAR T cells (CHT105)Biological
All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion.
| Study group | Role | What they receive |
|---|---|---|
| anti-CD19/CD70 CAR T cells（CHT105） | Experimental | All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion. Receives: Biological: anti-CD19/70 CAR T cells (CHT105) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis
- Types and incidence of dose-limiting toxicities (DLTs);
- Types, severity, and frequency of adverse events (AEs);
- Incidence and grading of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
Measured: From enrollment to the end of treatment at 52 weeks
Secondary outcomes (6)
Complete Renal Response (CRR)
Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved CRR:
Urinary protein excretion <0.5 g/24 h or urine protein-to-creatinine ratio (UPCR) <0.5 g/g; Estimated glomerular filtration rate (eGFR) decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²; No use of rescue medications exceeding protocol-specified thresholds prior to assessment.
Measured: at Week 24 after CHT105 infusion.
Partial Renal Response (PRR)
Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PRR:
eGFR decline ≤10-15% from baseline or eGFR ≥60 mL/min/1.73 m²;
Improvement in 24-hour UPCR:
- For participants with baseline UPCR ≤3.0 g/g: UPCR <1.0 g/g;
- For participants with baseline UPCR >3.0 g/g: >50% reduction from baseline and UPCR <3.0 g/g;
No use of rescue medications exceeding protocol-specified thresholds prior to assessment.
Measured: At at Week 24 after CHT105 infusion.
Primary Efficacy Renal Response (PERR)
Evaluated only in participants with lupus nephritis; participants meeting all the following criteria are considered to have achieved PERR:
UPCR ≤0.7 g/g; eGFR decline ≤20% from baseline or eGFR ≥60 mL/min/1.73 m²; No use of rescue medications exceeding protocol-specified thresholds prior to assessment.
Measured: At at Week 24 after CHT105 infusion.
Overall Renal Response (ORR)
Evaluated only in participants with lupus nephritis, encompassing those achieving either complete renal response (CRR) or partial renal response (PRR).
Measured: At at Week 24 after CHT105 infusion.
CRR, PRR, or PERR, and overall response rate
percentage of participants achieving CRR, PRR, or PERR, and overall response rate (i.e., percentage achieving either CRR or PRR)
Measured: At each follow-up visit between the first dose and Week 52.
the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) criteria
Trial participants who meet all of the following criteria are considered to have achieved the SRI response:
- A reduction of ≥4 points in the SLEDAI-2K score from baseline;
- No new BILAG A-grade organ involvement and no new BILAG B-grade involvement in two or more organs, as assessed by the BILAG-2004 index relative to baseline;
- No worsening in the Physician's Global Assessment (PGA), defined as an increase of <0.30 points on the Visual Analog Scale (VAS) from baseline;
- No use of rescue medications exceeding protocol-specified thresholds prior to assessment.
Measured: At each follow-up visit between the first dose and Week 52.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2026
- Study start22 Apr 2026
- Primary completionJan 2028 (estimated)
- Study completionJan 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 The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 14 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07517536
- Sponsor's protocol ID
- CHT105AIIT-02
- Status last verified
- May 2026
- First submitted
- 27 Mar 2026
- Last updated
- 18 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study to Evaluate the Safety and Efficacy of CHT105, an Allogeneic CAR-T Cell Injection Targeting CD19 and CD70, in Patients With Refractory Lupus Nephritis
- ClinicalTrials.gov ID
- NCT07517536
- Acronym / sponsor ID
- CHT105AIIT-02
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 14 participants (estimated)
- Lead sponsor
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical SchoolUniversity, hospital or other
- Study start
- 22 Apr 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Jan 2028 (estimated)
- First posted
- 8 Apr 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.
Systemic lupus erythematosus (SLE) is the most common systemic autoimmune disease in China. The kidneys are the organ most frequently affected in SLE and a major cause of mortality among SLE patients. Currently, cell-based therapy has emerged as an innovative treatment approach for SLE. CHT105 injection is an allogeneic chimeric antigen receptor T (CAR-T) cell product derived from healthy donors' T cells, which are transduced with a lentiviral vector encoding an anti-CD19/CD70 CAR. This engineered T-cell product effectively recognizes and eliminates immune cells expressing CD19 and/or CD70 antigens-including autoreactive T and B cells-and holds promise as a novel therapeutic option for patients with refractory lupus nephritis (LN).
This study is a clinical trial evaluating the safety and preliminary efficacy of CHT105 injection-a CD19/CD70-targeting allogeneic CAR-T cell product-in adult patients with relapsed or refractory LN. Eligible participants will first undergo lymphodepleting preconditioning. Following confirmation of eligibility per standard infusion criteria, participants will receive a single intravenous infusion of CHT105 on Day 0 (D0). After CHT105 infusion, participants will undergo a 52-week short-term follow-up and up to a 15-year long-term follow-up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| anti-CD19/CD70 CAR T cells（CHT105） | Experimental | Biological: anti-CD19/70 CAR T cells (CHT105)All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Age 18-65 years (inclusive), regardless of sex;
- Meets at least four of the 11 SLE classification criteria recommended by the American College of Rheumatology (ACR) in 1997; or fulfills the 2019 European League Against Rheumatism (EULAR)/ACR classification criteria for SLE;
- Diagnosed with active, biopsy-confirmed lupus nephritis (LN) class III or IV, with or without concurrent class V, according to the 2018 International Society of Nephrology (ISN)/Renal Pathology Society (RPS) classification; renal biopsy must have been performed within one year prior to screening or during the screening period;
- Urine protein-to-creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urinary sediment featuring red blood cell casts;
- Moderate-to-severe disease activity, as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6;
Key exclusion criteria (14 listed)
- Individuals with a history of severe drug allergy or allergic constitution;
- Presence of, or suspicion of, uncontrolled fungal, bacterial, viral, or other infections requiring hospitalization or intravenous therapy within one month prior to baseline;
- Any of the following cardiovascular or cerebrovascular events within six months prior to screening: unstable angina requiring hospitalization, myocardial infarction, coronary artery bypass grafting, percutaneous coronary intervention (diagnostic coronary angiography is permitted), moderate-to-severe congestive heart failure (NYHA Class III or IV), atrial or ventricular arrhythmias requiring hospitalization (e.g., atrial fibrillation, ventricular tachycardia), implantation of a pacemaker or defibrillator, cerebrovascular accident (e.g., stroke), or planned coronary artery bypass surgery or vascular reconstruction during the trial;
- Participants with congenital immunoglobulin deficiency;
- History of malignancy within the past five years (except for basal cell carcinoma, localized cutaneous squamous cell carcinoma, cervical carcinoma in situ, or thyroid carcinoma, all of which must have been definitively cured for at least one year);
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-CD19/70 CAR T cells (CHT105)All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion. | Biological | anti-CD19/CD70 CAR T cells（CHT105） |
Primary outcome
Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis
Time frame: From enrollment to the end of treatment at 52 weeks
* Types and incidence of dose-limiting toxicities (DLTs); * Types, severity, and frequency of adverse events (AEs); * Incidence and grading of cytokine release syndrome (CRS) and immune effector cell-associated neurotoxicity syndrome (ICANS).
6 secondary outcomes
Complete Renal Response (CRR)
Time frame: at Week 24 after CHT105 infusion.
Partial Renal Response (PRR)
Time frame: At at Week 24 after CHT105 infusion.
Primary Efficacy Renal Response (PERR)
Time frame: At at Week 24 after CHT105 infusion.
Overall Renal Response (ORR)
Time frame: At at Week 24 after CHT105 infusion.
CRR, PRR, or PERR, and overall response rate
Time frame: At each follow-up visit between the first dose and Week 52.
the Systemic Lupus Erythematosus Responder Index-4 (SRI-4) criteria
Time frame: At each follow-up visit between the first dose and Week 52.
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 18 Jun 2026.
- Individual participant dataSharing planned: Undecided
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A Trial in Healthy Adult Participants and Adults With Autoimmune Diseases to Test How HBM7020 is Tolerated and How it Behaves in the Body
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing anti-CD19/70 CAR T cells (CHT105) in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School 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 10 inclusion and 14 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: enrolling by invitation, as of the sponsor's last update on 18 Jun 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.
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of CHT105 Injection in Subjects with Refractory Lupus Nephritis (time frame: From enrollment to the end of treatment at 52 weeks). 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 18 Jun 2026.