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Systemic Lupus Erythematosus (SLE)NCT05988216

Universal CAR-T Cells (BRL-301) in Refractory Systemic Lupus Erythematosus

A study testing BRL-301 in people with Systemic Lupus Erythematosus (SLE), run by Bioray Laboratories 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 The sponsor has not verified this record for over two years, so it may be out of date.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 an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Systemic Lupus Erythematosus (SLE)
What is being tested?
BRL-301
Could I receive a placebo?
No, everyone receives an active treatment
How many people
12 participants
Where
1 siteChina
Study dates
14 Aug 2023to Sep 2025
Phase
Interventional
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 range from 18 to 65 years old (including threshold), regardless of gender;
  • Subjects diagnosed with SLE according to the 2019 EULAR/ACR SLE classification criteria; ANA ≥ 1:80, or positive for anti dsDNA and/or anti Sm antibodies;
  • The condition becomes active again after conventional treatment is ineffective or the disease relapses. Conventional treatment is defined as the use of two or more drugs, including corticosteroids (more than 1mg/kg/d) and any one or more of the following immunomodulatory drugs for over six months: antimalarial drugs, cyclophosphamide, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, as well as biologics including rituximab, belimumab, etanercept, etc.
  • At least one BILAG2004 Class A or two Class B score, or both;
  • SELENA-SLEDAI score ≥ 8 points;
  • The positive expression and expression rate of CD19 on peripheral blood B cells determined by flow cytometry;
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  • The functions of important organs meet the following requirements:
  • Bone marrow function needs to meet:
  • White blood cell count ≥ 3 × 109/L;
  • Neutrophil count ≥ 1 × 109/L (no Colony-stimulating factor treatment within 2 weeks before examination);
  • Platelets ≥ 50 × 109/L;d. Hemoglobin ≥ 80g/L
  • Liver function:
  • Alanine Aminotransferase (ALT) ≤ 3 × ULN;
  • Asparagus cochinchinensis transase (AST) ≤ 3 × ULN;
  • Total Bilirubin (TBIL) in serum ≤ 1.5 × ULN (excluding Gilbert syndrome, total bilirubin ≤ 3.0 × ULN); Renal function: Creatinine Clearance Rate (CrCl) ≥ 60 ml/minute (Cockcroft/Fault formula) ;
  • Coagulation function:
  • International Normalized Ratio (INR) ≤ 1.5 × ULN,
  • Prothrombin time (PT) ≤ 1.5 × ULN.
  • Cardiac function: good hemodynamic stability, left ventricular Ejection fraction (LVEF) ≥ 55%;
  • Female patients of childbearing potential and male patients whose female sexual partners are of childbearing age should adopt medically recognized contraceptive measures or abstain from sex within at least 6 months after infusion of BRL-301; female patients of childbearing age should have a negative serum HCG test result within 7 days before study enrollment and be not breastfeeding;
  • Willing to participate in this clinical study, sign an ICF, and complete follow-ups, with good compliance.

Who cannot join

  • Have a serious history of Drug allergy or allergic constitution;
  • Fungi, bacteria, viruses, or other infections that are uncontrollable or require intravenous medication treatment exist or are suspected;
  • Active central nervous system disease caused by SLE or not (including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident, encephalitis, central nervous system Vasculitis);
  • Individuals with relatively serious heart diseases, such as angina pectoris, myocardial infarction, heart failure, and arrhythmia;
  • Subjects with congenital immunoglobulin deficiency;
  • Other malignant tumors (excluding non Melanoma skin cancer, cervical cancer in situ, bladder cancer cancer and breast cancer that have survived for more than 5 years without disease);
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  • Subjects with end-stage renal failure;
  • Have received any of the following SLE treatments:
  • Corticosteroid (defined as prednisone or equivalent>20 mg/day) of therapeutic dose were used before enrollment or within 72 hours before BRL-301 infusion.
  • Use any other clinical study drugs for SLE within 4 weeks prior to enrollment. However, if the research treatment period is ineffective or the disease progresses, and at least 3 half-lives have passed before enrollment, enrollment is allowed.
  • Had received anti CD20 monoclonal antibody (such as Rituximab) within 4 weeks before screening, tetaximab within 6 weeks, or belizumab within 12 weeks.
  • Previous CAR-T cell or other genetically modified T Cell therapy.
  • Subjects with positive hepatitis B B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) and HBV DNA titer in peripheral blood higher than the upper limit of detection; Patients with positive hepatitis C virus (HCV) antibodies and positive peripheral blood HCV RNA; People who are positive for human immunodeficiency virus (HIV) antibodies; Those who have tested positive for syphilis;
  • Having mental illness and severe cognitive impairment;
  • Those who have participated in other clinical trials within the first 3 months of enrollment;
  • Pregnant or intending to conceive women;
  • Patients who are unsuitable for being included into this study as deemed by the investigator due to other reasons.

Trial locations and contacts

1 site in 1 country.

Hongyan Tong, Doctor contact

8613958122357

hongyantong@aliyun.com

China1 site, 1 recruiting

  • The First Affiliated Hospital, Zhejiang University School of Medicine

    Hangzhou, Zhejiang

    Tong Hongyan, Doctor, +86 13958122357, hongyantong@aliyun.com

    Recruiting

Other trials in China

About this study

Official title: A Clinical Study on the Safety and Efficacy of BRL-301 (Allogeneic Chimeric Antigen Receptor T Cell Injection Targeting CD19 Gene) in the Treatment of Refractory Systemic Lupus Erythematosus

This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the refractory systemic lupus erythematosus.

Read the detailed description

The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up.

Being tested
BRL-301
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.

  • BRL-301Biological

    Also called Allogeneic Anti-CD19 CAR T cells

    Single dose of Allogeneic Anti-CD19 CAR T cells will be infused

Study groups in NCT05988216
Study groupRoleWhat they receive
BRL-301ExperimentalAllogeneic CD19-targeted Chimeric AntigenReceptor (CAR) T Cells
Receives: Biological: BRL-301

What is being measured

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

  1. The safety of BRL-301 in refractory systemic lupus erythematosus

    Incidence and severity of AEs and SAEs, including changes in laboratory values, ECG and vital signs as assessed by CTCAE v5.0.

    Measured: 3 months

Secondary outcomes (2)

  1. The efficiency of BRL-301 in refractory systemic lupus erythematosus

    Number of patients with SRI-4 response: including SELENA-SLEDAI ≥4-Point improvement, BILAG 2004 with No new A domain score AND no more than 1 new B domain scores, PGA with No worsening (<0.3-point increase)

    Measured: 3 months

  2. Cellular kinetics

    CAR transgene levels by quantitative polymerase chain reaction (qPCR) in peripheral blood

    Measured: 3 months

Timeline

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

  1. First posted14 Aug 2023
  2. Study start14 Aug 2023
  3. Primary completionDec 2024 (estimated)
  4. Study completionSep 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 N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
12 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05988216
Sponsor's protocol ID
2022-BRL-301A-SLE-IIT
Status last verified
Sep 2024
First submitted
4 Aug 2023
Last updated
27 Sep 2024
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing BRL-301 in people with Systemic Lupus Erythematosus (SLE), run by Bioray Laboratories 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 21 inclusion and 17 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 27 Sep 2024. 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?

Results are not available in the source record.

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

Contact Hongyan Tong, Doctor (8613958122357, hongyantong@aliyun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The safety of BRL-301 in refractory systemic lupus erythematosus (time frame: 3 months). 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 NCT05988216.

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 27 Sep 2024.

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