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Systemic Lupus ErythematosusPhase 1NCT06340490

A Study of RJMty19 in Refractory Systemic Lupus Erythematosus (SLE)

A Phase 1 study testing RJMty19 (CD19-CAR-DNT cells) in people with Systemic Lupus Erythematosus, run by Guangdong Ruishun Biotech Co., Ltd at 4 sites in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
RJMty19 (CD19-CAR-DNT cells)
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
24 participants
Where
4 sitesChina
Study dates
15 May 2024to 31 Dec 2027
Phase
Phase 1
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign an ICF and expect to complete the subsequent follow-up.
  • Age 18～65 years old (including cut-off value), gender is not limited.
  • Diagnosed with SLE according to the 2019 EULAR/ACR version of the revised criteria.
  • Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score ≥ 8 points; Anti-nuclear antibody titer ANA≥1:80, or positive anti-dsDNA and/or anti-Sm antibodies.
  • Presence of active organ involvement.
  • Having appropriate organ function, and the laboratory test results within 7 days before the lymphodepletion must meet the following criteria:
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  • Coagulation function:
  • Fibrinogen ≥1.0 g/L;
  • Activated partial thromboplastin time ≤ 1.5 times the upper limit of normal (ULN);
  • Prothrombin time (PT) ≤ 1.5 times ULN.
  • Liver function:
  • Glutathione aminotransferase (AST) ≤ 3 times the upper limit of normal (ULN);
  • Glutamic aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN);
  • Total bilirubin ≤ 1.5 times ULN, unless the subject has documented Gilbert syndrome;
  • Subjects with Gilbert-Meulengracht syndrome with total bilirubin ≤ 3.0 times ULN and direct bilirubin ≤ 1.5 times ULN may be included.
  • Renal function:
  • Serum creatinine ≤ 1.5 times ULN or a creatinine clearance ≥ 60 ml/min;
  • Complete blood count:
  • Haemoglobin ≥ 80 g/L;
  • Absolute neutrophil count (ANC) ≥ 1.0 x 10^9/L;
  • Platelet count ≥ 50 x 10^9/L;
  • Cardiopulmonary function:
  • Left ventricular ejection fraction (LVEF) ≥ 45%;
  • Oxygen saturation ≥ 91%
  • Female patients with of childbearing potential should have a negative pregnancy test during the screening period. Any male and female patients of childbearing potential must agree to use an effective contraception method for at least six months from the time that they sign the informed consent form until the end of the cell infusion. Female subjects with non-childbearing potential (meeting at least 1 of the following criteria) is described below:
  • Have undergone a hysterectomy or bilateral oophorectomy;
  • Medically recognised ovarian failure;
  • Medically recognised as post-menopausal (at least 12 consecutive months of menopause without pathological or physiological cause).
  • Use of hormones and at least two standard immunosuppressants and at least one biological agent for more than six months without meeting the LLDAS criteria; or allergy, intolerance and other drug-related side effects to the components of the biological agent make it impossible for the user to continue;
  • Life expectancy greater than 6 months;
  • Confirmed presence of CD19 positive B cells in peripheral blood by flow cytometry.

Who cannot join

  • Other malignancies within 5 years prior to screening, except adequately treated non-melanoma skin cancer (basal cell carcinoma or squamous cell carcinoma) or carcinoma in situ of the cervix;
  • Major surgery requiring hospitalization within 4 weeks prior to screening or during screening;
  • History of severe drug allergies or anaphylactic constitution;
  • Renal disease: Diagnosed with active severe lupus nephritis within 8 weeks prior to screening, requiring treatment with drugs prohibited by the study protocol for the treatment of active nephritis, hemodialysis or prednisone dose ≥ 100 mg/d, or equivalent glucocorticoids for ≥14 days; Creatinine clearance rate < 60mL/min and serum creatinine > 1.5 times ULN within 1 week before lymphodepleting chemotherapy;
  • Central nervous system diseases: those with active central nervous system diseases caused by SLE or non-SLE (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system vasculitis);
  • Cardiovascular disease: unstable angina, myocardial infarction, New York Heart Association class III or IV cardiac insufficiency, refractory hypertension (The definition of refractory hypertension is: on the basis of improving lifestyle, reasonable and tolerable use of ≥3 antihypertensive drugs (including diuretics) for more than 1 month, blood pressure still not reached the target (systolic blood pressure≥ 150 mmHg and/or diastolic blood pressure ≥ 100 mmHg) or taking ≥4 antihypertensive drugs to effectively control blood pressure) and a history of severe arrhythmias requiring medication;
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  • Positive hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and peripheral blood hepatitis B virus (HBV) DNA titer test higher than the lower limit of the detection value, hepatitis C virus (HCV) antibody positive and peripheral blood hepatitis C virus (HCV) RNA positive, human immunodeficiency virus (HIV) antibody positive, cytomegalovirus (CMV) DNA test positive, syphilis test positive;
  • Presence of active or uncontrollable infection requiring systemic treatment (other than simple urinary tract infection or upper respiratory tract infection) and currently receiving suppressive therapy for any chronic infection (such as tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster and atypical mycobacteria); untreated latent tuberculosis infection;
  • There is clinical evidence showing the presence of important, unstable, or uncontrolled acute or chronic diseases not caused by SLE (i.e. cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignant tumors, or infectious diseases), which researchers believe may confound the study results or expose subjects to unnecessary risks;
  • Vaccination with live or attenuated live vaccine within 1 month before screening;
  • History of/preparing to undergo organ transplantation or hematopoietic stem cell transplantation;
  • Received CAR-T therapy or other gene-modified cell therapy prior to enrolment;
  • Have received any of the following treatments for SLE:
  • Use of therapeutic doses of corticosteroids (defined as prednisone or equivalent> 20 mg/d) within 72 hours prior to lymphodepleting chemotherapy or RJMty19 infusion;
  • Treatment of SLE with any other clinical investigational agent within 4 weeks prior to enrollment. However, enrollment is allowed if the study treatment period is ineffective or the disease has progressed, and at least 3 half-lives have elapsed prior to enrollment;
  • Received belimumab within 8 weeks and anti-CD20 monoclonal antibody (e.g., rituximab) within 6 months prior to screening;
  • Blood transfusion, packed red blood cells, and platelet transfusion within 6 weeks prior to enrollment;
  • Plasmapheresis and plasmapheresis were treated within 3 months prior to enrollment;
  • Congenital immunoglobulin deficiency;
  • Participated in other clinical studies within the previous 3 months, except for clinical studies that have been evaluated by the investigator as not interfering with the safety and efficacy of the study drug, such as non-intervention observational studies;
  • In the judgment of the investigator and/or clinical criteria, there are contraindications to any of the study procedures or other medical conditions that may expose to unacceptable risks;
  • Presence of other autoimmune diseases that may interfere with the evaluation of efficacy (including but not limited to: rheumatoid arthritis, spondyloarthritis, dermatomyositis/polymyositis, systemic sclerosis, mixed connective tissue disease, etc.).

Trial locations and contacts

4 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Haicun Xie contact

+086-18358586096

hcxie@wyzebiotech.com

China4 sites

  • Peking University People's Hospital

    Beijing, Beijing Municipality, 100044

    Zhanguo Li, MD, PHD, +086-13910713924, li99@bjmu.edu.cn

    Chun Li, MD, PHD, +086-13811190098, 13811190098@163.com

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008

    Lingyun Sun, MD, PhD, +086-025-83105555, lingyunsun2012@163.com

  • Renji Hospital Affiliated to Shanghai Jiaotong University School of Medicine

    Shanghai, Shanghai Municipality, 200001

    Shuang Ye, MD, PHD, +086-13817615871, ye_shuang2000@163.com

    Qiong Fu, MD, PHD, +086-13585603288, fuqiong@renji.com

  • Changhai Hospital

    Shanghai, Shanghai Municipality, 200433

    Dongbao Zhao, MD, PhD, +86-15921061314, dongbaozhao@163.com

    Jie Gao, MD, PhD, +086-13585561861, gaojif@tom.com

Other trials in China

About this study

Official title: A Phase I Clinical Trial of RJMty19 in Treatment of Subjects With Refractory Systemic Lupus Erythematosus

This study is an open-label, single-arm, dose escalation and dose expansion study to evaluate the safety, maximum tolerated dose, pharmacokinetic characteristics of allogeneic CD19-CAR-DNT cells (RJMty19) after infusion, and preliminary efficacy in systemic lupus erythematosus (SLE) subjects.

Read the detailed description

The dose escalation part (Part A) plans to enroll 9-18 subjects with refractory SLE receiving RJMty19 infusion to determine the maximum tolerated dose (MTD) and/or RP2D of RJMty19. The dose expansion part (Part B) plans to enroll 3-6 subjects. The Safety Review Committee (SRC) monitors the safety information of the subjects and evaluates the safety data of each dose group. To ensure the quality of the experiment, the sponsor and inverstigators will jointly discuss and formulate the clinical research plan before the formal experiment begins.

Being tested
RJMty19 (CD19-CAR-DNT cells)
Keywords
off-the-shelf cell product, CAR-DNT, Cell Therapy, Autoimmune Disease
Medical subject headings
Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RJMty19 (CD19-CAR-DNT cells)Biological

    Also called Fludarabine, Cyclophosphamide

    Lentiviral vector-transducted double negative T cells (DNT) to express anti-CD19 CAR. Prior to cellular infusion, each patient received cyclophosphamide and fludarabine lymphodepleting chemotherapy.

Study groups in NCT06340490
Study groupRoleWhat they receive
RJMty19 (CD19-CAR-DNT Cells)ExperimentalThe trial is divided into two parts: Part A is a dose escalation trial with three dose groups (5×10^6 CAR+ cells/kg, 1×10^7 CAR+ cells/kg, 2×10^7 CAR+ cells/kg at day 0), with 9-18 patients planned to be enrolled. Part B is a dose-expansion trial in which 3~6 patients will receive RJMty19 infusions at RP2D dose levels
Receives: Biological: RJMty19 (CD19-CAR-DNT cells)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT)

    To evaluate the safety, tolerability, and determine the recommended dosage of RJMty19 for SLE subjects

    Measured: Up to 28 days

  2. Maximum Tolerated Dose (MTD)

    MTD is the highest dose for DLT in ≤1/6 subjects

    Measured: Up to 28 days

  3. Incidence of abnormalities

    Incidence of abnormalities in AE/SAE/AESI/laboratory tests/electrocardiograms/vital signs.

    Measured: Up to 28 days

Secondary outcomes (5)

  1. Pharmacokinetics (PK) indicator (Cmax)

    The peak concentration of CD19-CAR-DNT cells amplified in the peripheral blood (Cmax, detected by qPCR and Flow Cytometry).

    Measured: Up to 28 days

  2. Pharmacokinetics (PK) indicator (AUC)

    CD19-CAR-DNT cells blood concentrations will be measured at different time points to evaluate the area under the curve (AUC). (AUC, detected by qPCR and Flow Cytometry)

    Measured: Up to 90 days

  3. Pharmacokinetics (PK) indicator (CAR copy numbers)

    Changes in CAR copy numbers after injection of RJMty19

    Measured: Up to 24 months

  4. Remission rate of SLE based on DORIS criteria

    cSLEDAI=0 and PGA < 0.5

    Measured: at 3 months, 6 months, 12 months and 24 months

  5. Remission rate of SLE based on LLDAS criteria

    SLEDAI-2K ≤ 4 points without manifestations of major organ and system involvement (renal, central nervous, cardiopulmonary, vasculitis, fever); No new disease activity compared to previous assessments (SLEDAI-2K); Physician's global assessment (PGA, 0-3) ≤1; prednisone dose (or equivalent) ≤ 7.5 mg/d; Use of stable doses of immunosuppressants and approved biologics.

    Measured: at 3 months, 6 months, 12 months and 24 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Apr 2024
  2. Study start15 May 2024 (estimated)
  3. Primary completion31 Dec 2026 (estimated)
  4. Study completion31 Dec 2027 (estimated)

Resources

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
24 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06340490
Sponsor's protocol ID
RJMty19-AID002
Status last verified
Mar 2024
First submitted
25 Mar 2024
Last updated
1 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing RJMty19 (CD19-CAR-DNT cells) in people with Systemic Lupus Erythematosus, run by Guangdong Ruishun Biotech Co., Ltd at 4 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 31 inclusion and 22 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: opening soon, as of the sponsor's last update on 1 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 4 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Haicun Xie (+086-18358586096, hcxie@wyzebiotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) (time frame: Up to 28 days). The study lists 3 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 NCT06340490.

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 1 Apr 2024.

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