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Relapsed/Refractory, Systemic Lupus Erythematosus (SLE)Phase 1NCT05474885

BCMA-CD19 cCAR T Cell Treatment of Relapsed/Refractory Systemic Lupus Erythematosus (SLE)

A Phase 1 study testing BCMA-CD19 cCAR T cells in people with Relapsed/Refractory, Systemic Lupus Erythematosus (SLE), run by iCell Gene Therapeutics at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
BCMA-CD19 cCAR T cells
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
15 participants
Where
1 siteChina
Study dates
1 Apr 2022to 30 Apr 2025
Phase
Phase 1
Are there results?
None posted in the registry

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 old;
  • Expected survival period ≥ 3 months;
  • Serum creatinine <221.0μmol/L (2.5mg/dl);
  • AST/ALT below 3 times the upper limit of normal, blood bilirubin <34.2 μmol/L (2.0 mg/dl);
  • Cardiopulmonary function is basically normal, echocardiography indicates that the ejection fraction is >50%, and the oxygen saturation is above 94% in the resting state without oxygen;
  • No obvious active infection;
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  • Physical fitness score 0~2 points (ECOG standard);
  • There are suitable veins for blood cell apheresis or whole blood collection, and there are no contraindications for blood collection;
  • Since the effect of CAR T cell therapy on the fetus is unknown, women of childbearing age should have a negative serum or urine pregnancy test 48 hours before CAR T cell reinfusion, and agree to take effective measures during the trial until the last follow-up. contraceptive measures;
  • Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.

Who cannot join

  • Severe systemic lupus erythematosus: BILAG score at least 1 system is A and (or) >2 systems reach B, or SELENA SLEDAI>12 points.
  • CNS disease: Active central nervous system (CNS) lupus (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis), visual Disorders, cranial neuropathy requiring intervention
  • Abnormal liver function: aspartate transaminase (AST) or alanine transaminase (ALT) or glutamyl transpeptidase (GGT) detection value is greater than 3 times the upper limit of normal (ULN); or alkaline phosphatase ( ALP) or total bilirubin test value greater than 1.5 times the upper limit of normal (ULN);
  • Kidney disease: hemodialysis or high-dose glucocorticoid treatment is required within 90 days before visit 2, such as prednisone (or equivalent dose of glucocorticoid) ≥ 100 mg/d, or creatinine (Cr) or blood urea nitrogen (BUN) detection value greater than 1.5 times the upper limit of normal (ULN), or eGFR ≤ 60ml/min before visit 2. eGFR is calculated using the MDRD formula: eGFR (ml/min×1.73m^2)=186×serum creatinine (Scr)-1.154×age-0.203× (multiply by 0.724 if the subject is a female)
  • Cardiovascular disease: history of acute myocardial infarction, or unstable angina pectoris, severe arrhythmia (multi-source frequent premature ventricular tachycardia, ventricular tachycardia, ventricular fibrillation) in the past 6 months; New York heart function class (NYHA) class III- Level IV
  • Other uncontrolled diseases: acute or chronic diseases (such as acute pneumonia, pulmonary hypertension, diabetic ketoacidosis, acute pancreatitis, etc.) that are clinically unstable or have not been effectively controlled and are not related to SLE. judgments that may confound study results or place subjects at undue risk.
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  • Infection: Subject has acute or chronic infection requiring treatment (eg, tuberculosis, pneumocystis, cytomegalovirus, herpes simplex virus, herpes zoster, and atypical mycobacteria)
  • Surgery or other conditions: planning to undergo surgery or have any other medical history (eg, recent history of sepsis), abnormal laboratory tests, or other conditions, judged by the investigator to be inappropriate to participate in this study
  • Biologics therapy: Received any drug therapy (antibody, inhibitor or agonist) targeting T, B lymphocytes, cytokines or receptors within two months
  • Participated in any clinical study within 3 months prior to enrollment
  • The use of contraindicated drugs or therapies may affect the judgment of the efficacy of CART: 1) Received any of the following treatments within 90 days before Visit 2: (1) Intravenous immune globulin (IVIG); (2) Oral high-dose glucocorticoids Hormones, such as prednisone >100mg/d; (3) plasma exchange, leukotomy; 2) new immunosuppressive/immune modulators were added within 60 days before visit 2, and the disease is still under control.
  • Received live vaccine treatment within 30 days prior to Visit 2
  • Transplantation: History of vital organ transplantation (eg, heart, lung, kidney, liver) or hematopoietic stem cell/or bone marrow transplantation
  • HIV positive.
  • Active hepatitis B or C.
  • Suffering from malignant tumors of other organs at the same time.
  • Pregnant or lactating women.
  • Inability to understand or follow the research protocol.
  • Participate in other clinical investigators during the same period.
  • Have any other clinically significant disease history or current disease that, in the judgment of the research physician, may pose a risk to the safety of the subjects, or interfere with the completion of the research procedure and the evaluation of safety and efficacy.

Trial locations and contacts

1 site in 1 country.

Kevin Pinz contact

6315386218

kevin.pinz@icellgene.com

Wei-Jia Wang, MD contact

011-86-13715679657

wangwj@zsph.com

China1 site, 1 recruiting

  • Zhongshan People's Hospital

    Zhongshan, Guangdong

    Wei-Jia Wang, MD, 011-86-13715679657, wangwj@zsph.com

    Recruiting

Other trials in China

About this study

This is a phase I, interventional, single arm, open label, treatment study to evaluate the safety and tolerability of BCMA-CD19 cCAR T cells in patients with relapsed and/or refractory SLE.

Read the detailed description

Systemic lupus erythematous (SLE) is a chronic diffuse connective tissue disease with unexplained etiology that can involve multiple systems in the body. SLE is considered as an incurable disease and traditional SLE treatment aims at long-term remission. Glucocorticoids combined with immunosuppressive agents are still the main treatment strategies. Recently, biological agents targeting abnormal immune cells, such as rituximab and belimumab, which deplete B cells have also achieved some success in the treatment of SLE. However, these agents cannot permanently reverse the production of abnormal antibodies as they are unable to eliminate pathogenic long-lived plasma cells. The BCMA-CD19 CAR T-cells are designed to deplete antibody-producing 'root", B cells and plasma cells.

Being tested
BCMA-CD19 cCAR T cells
Keywords
BCMA-CA19 CAR, lupus, SLE, systemic lupus erythematosus, autoimmune disorders
Medical subject headings
Recurrence, Lupus Erythematosus, Systemic, Autoimmune Diseases

What participants receive

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

  • BCMA-CD19 cCAR T cellsBiological

    BCMA-CD19 cCAR T cells are used to treat patients. Patient will be administered either fresh or thawed CAR T cells by IV injection after receiving lymphodepleting chemotherapy.

Study groups in NCT05474885
Study groupRoleWhat they receive
BCMA-CD19 cCAR T cellsExperimentalDose escalation phase: patient's T cells will be transduced with a lentiviral vector to express a BCMA-CD19 cCAR. with an escalation approach.
Receives: Biological: BCMA-CD19 cCAR T cells

What is being measured

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

  1. The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion

    Evaluation all possible adverse reactions, including the number, incidence, and severity of symptoms such as cytokine release syndromes and neurotoxicity within 3 months after CAR infusion.

    Measured: 3 months after CAR infusion

Secondary outcomes (5)

  1. Autoantibody detection

    Autoantibody detection up to 6 months after BCMA-CD19 cCAR T cells infusion

    Measured: 6 months after CAR infusion

  2. SLEAI score

    SLEAI score taken up to 2 years after BCMA-CD19 cCAR T cells infusion

    Measured: 2 years after CAR infusion

  3. Renal functions

    Renal functions monitored up to 1years after BCMA-CD19 cCAR T cells infusion

    Measured: 1 year after CAR infusion

  4. Disease control

    Disease control monitored up to 2 years after BCMA-CD19 cCAR T cells infusion)

    Measured: 2 years after CAR infusion

  5. Overall survival

    Overall survival (2 year after CAR infusion). The time from the start of BCMA-CD19 cCAR infusion to death is determined as the overall survival

    Measured: 2 years after CAR infusion

Timeline

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

  1. First posted26 Jul 2022
  2. Study start1 Apr 2022
  3. Primary completion30 Apr 2025 (estimated)
  4. Study completion30 Apr 2025 (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
Sequential
Masking
None (open label)
Enrolment
15 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05474885
Sponsor's protocol ID
ICG180-001
Status last verified
Apr 2022
First submitted
23 Jul 2022
Last updated
26 Jul 2022
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Jiang Q, Wang M, Wang M, Zhou J, Zheng K, Ding L, Hong M. Successful Spontaneous Pregnancies and Healthy Neonates After Dual-Target CAR-T Cell Therapy in Systemic Lupus Erythematosus. Arthritis Rheumatol. 2026 Aug;78(8):1687-1691. doi: 10.1002/art.70070. Epub 2026 Feb 11.

    PubMed 41669912

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing BCMA-CD19 cCAR T cells in people with Relapsed/Refractory, Systemic Lupus Erythematosus (SLE), run by iCell Gene Therapeutics 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 20 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: status not confirmed, as of the sponsor's last update on 26 Jul 2022. 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?

Results are not available in the source record.

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

Contact Kevin Pinz (6315386218, kevin.pinz@icellgene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The number and incidence of adverse events after BCMA-CD19 cCAR T cell infusion (time frame: 3 months after CAR infusion). 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 NCT05474885, which also lists 1 linked publication.

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 26 Jul 2022.

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