CHT105 for the Treatment of Refractory Lupus Nephritis

April 1, 2026 updated by: The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
14

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Jiangsu
      • Nanjing, Jiangsu, China, 210008
        • The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18-65 years (inclusive), regardless of sex;
  2. 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;
  3. 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;
  4. 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;
  5. Moderate-to-severe disease activity, as indicated by a Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 6;
  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;
  7. Positive expression of CD19 and CD70 on peripheral blood B cells, as confirmed by flow cytometry;
  8. 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;
  9. 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;
  10. Voluntarily participates in this clinical study, provides written informed consent, demonstrates good adherence, and agrees to comply with follow-up requirements.

Exclusion Criteria:

  1. Individuals with a history of severe drug allergy or allergic constitution;
  2. Presence of, or suspicion of, uncontrolled fungal, bacterial, viral, or other infections requiring hospitalization or intravenous therapy within one month prior to baseline;
  3. 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;
  4. Participants with congenital immunoglobulin deficiency;
  5. 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);
  6. Participants with end-stage renal failure;
  7. 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;
  8. 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;

  9. At screening, organ function must meet the following criteria:

    a) 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;

  10. Presence of psychiatric disorders or severe cognitive impairment (excluding neuropsychiatric SLE);
  11. Participation in another clinical trial within one month prior to enrollment;
  12. Pregnant women or women planning pregnancy;
  13. Participants deemed ineligible for this study by the investigator for any other reason.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: anti-CD19/CD70 CAR T cells（CHT105）
All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion.
Biological: anti-CD19/70 CAR T cells (CHT105)
All subjects will receive fludarabine/cyclophosphamide lymphodepletion followed by CHT105 infusion.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
From enrollment to the end of treatment at 52 weeks

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Complete Renal Response (CRR)
Time Frame: at Week 24 after CHT105 infusion.

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.
at Week 24 after CHT105 infusion.
Partial Renal Response (PRR)
Time Frame: At at Week 24 after CHT105 infusion.

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.
At at Week 24 after CHT105 infusion.
Primary Efficacy Renal Response (PERR)
Time Frame: At at Week 24 after CHT105 infusion.

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.
At at Week 24 after CHT105 infusion.
Overall Renal Response (ORR)
Time Frame: At at Week 24 after CHT105 infusion.
Evaluated only in participants with lupus nephritis, encompassing those achieving either complete renal response (CRR) or partial renal response (PRR).
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.
percentage of participants achieving CRR, PRR, or PERR, and overall response rate (i.e., percentage achieving either CRR or PRR)
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.

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.
At each follow-up visit between the first dose and Week 52.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
April 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2028

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
January 1, 2028

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
March 27, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 8, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 8, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 1, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
March 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • CHT105AIIT-02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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