An interventional study of BRL-301 in Systemic Lupus Erythematosus (SLE), Sjogren's Syndrome and Systemic Sclerosis, sponsored by Bioray Laboratories. Enrolling by invitation at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-11-20.
Sponsored by Bioray Laboratories · Not applicable, Interventional, and Treatment
Among 265 studies in Lupus Erythematosus, Systemic with a site in China — 167 open to participants now, 190 under way, 22 of them phase 3. Lupus Erythematosus, Systemic · China.
Among the 265 studies in Lupus Erythematosus, Systemic with a site in China, this one is the 193rd largest by planned enrollment of the 244 interventional ones that give a count, is one of 24 that started in 2023, is one of 31 with no phase, reaches primary completion later than 0 of the 189 other live ones, and was the 89th registered.
1,208 studies on the registry are indexed under Lupus Erythematosus, Systemic; 404 are open to participants now.
Browse Lupus Erythematosus, Systemic studies →167 of the 265 studies in Lupus Erythematosus, Systemic with a site in China are open now. Recruiting first, the newest first:
Genentech, Inc. · Sites in China, Australia, Brazil and 3 more countries
Ages 18–75
Antengene Biologics Limited · Sites in China
Ages 18+
AstraZeneca · Sites in China, United States, Argentina and 32 more countries
Ages 5–80
AstraZeneca · Sites in China
Ages 18–70
Peking Union Medical College Hospital · Sites in China
Ages 6–18
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 283 Lupus Erythematosus, Systemic studies recruiting now, 92 (33%) set no upper age limit and 161 (57%) stop at 75 or younger; 54 take children under 18; 33 take healthy volunteers.
This study: 18 Years to 65 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
265 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 128 · Phase 2 56 · Phase 3 36 · Phase 4 16
First in 2006; this study’s year is marked. 24 started in 2023.
By drug class, each counting the studies that test any of its medicines:
This study's planned enrollment of 15 is below the median of 52 across 876 interventional studies indexed under Lupus Erythematosus, Systemic.
Median enrollment 36 across the 244 interventional studies, 180 across the 21 observational. Of the 54 that completed or were terminated, 25 (46%) have results posted.
This tab as a report to print or save as PDF → With an account.
133 of 265 have an industry lead sponsor. The 10 most frequent:
This study is registered under Bioray Laboratories, one of the names counted as BRL Medicine Inc.. Under that name alone:
Bioray Laboratories is the lead sponsor of 24 studies on the registry; 14 are open to participants now.
BRL Medicine Inc. has 2 studies filed under Lupus Erythematosus, Systemic — fewer than ten, so there is no comparison to draw.
59 of the studies in Lupus Erythematosus, Systemic with a site in China that are under way reach primary completion within a year, 5 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05138133Phase 3AstraZenecaPhase 3 Study of Anifrolumab in Adult Patients With Active Proliferative Lupus Nephritis | 2027-02-23 |
| NCT05843643Phase 3AbbVieProgram to Assess Adverse Events and Change in Disease Activity of Oral Upadacitinib in Adult Participants With Moderate to Severe Systemic Lupus Erythematosus | 2027-03 |
| NCT05639114Phase 3Novartis PharmaceuticalsPhase 3 Study to Evaluate Two Regimens of Ianalumab on Top of Standard-of-care Therapy in Patients With Systemic Lupus Erythematosus (SIRIUS-SLE 1) | 2027-03-26 |
| NCT05126277Phase 3Novartis PharmaceuticalsSafety, Efficacy and Tolerability of Ianalumab Versus Placebo, Combination With SoC Therapy, in Participants With Active Lupus Nephritis | 2027-09-21 |
| NCT07657793Phase 3Chinese SLE Treatment And Research GroupSirolimus in Patients With Systemic Lupus Erythematosus-Associated Immune Thrombocytopenia | 2027-09-30 |
Add all 59 to your calendar (.ics) → With an account.
Among the 265 studies in Lupus Erythematosus, Systemic with a site in China, from their registry updates:
This tab as a report to print or save as PDF → With an account.
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
This is an investigator initiated trial to assess the efficacy and safety of BRL-301 in the relapse or refractory autoimmune diseases of China.
The study had the following sequential phases: Screening, Pre-Treatment (Cell Product Preparation \& Lymphodepleting Chemotherapy), Treatment and Follow-up.
Common Inclusion Criteria:
The functions of important organs meet the following requirements:
Criteria for SLE:
Criteria for Sjogren's syndrome with thrombocytopenia:
Criteria for Systemic Sclerosis:
Needs to be met 1. or 2.:
Criteria for Inflammatory Myopathy:
Needs to be met 1.or 2.:
Criteria for ANCA Associated Vasculitis:
Criteria for Antiphospholipid syndrome:
Needs to be met 1. or 2.:
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hemoglobin (Hb)
The protein in red blood cells that carries oxygen. A low level is anaemia, which can cause tiredness and breathlessness. Measured in g/dL or g/L (9 g/dL is 90 g/L).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Bilirubin
A yellow substance made when red blood cells are broken down, which the liver clears. A high level can mean a problem with the liver or the bile ducts.
Criteria often allow more for people with Gilbert’s syndrome, a harmless inherited condition that raises bilirubin.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Creatinine clearance (CrCl)
How quickly the kidneys clear creatinine, a waste product, from the blood. A study may estimate it from a blood test with age, weight and sex (often by the Cockcroft–Gault formula), or measure it using blood and urine collected over a set time. Given in mL/min; higher is better.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
INR, PT and aPTT (clotting tests)
Blood tests of how long blood takes to clot. The INR is the prothrombin time (PT) put on a common scale; about 1 is usual for someone not taking a blood thinner.
Criteria often make an exception for people on a blood thinner such as warfarin, whose INR is raised on purpose.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Histologically or cytologically confirmed
The diagnosis was confirmed by looking at a sample under a microscope: tissue from a biopsy or surgery (histology), or cells from a fluid or needle sample (cytology).
Your pathology report is the document that shows this.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Allogeneic CD19-targeted Chimeric Antigen Receptor (CAR) T Cells
Biological: BRL-301
Single dose of Allogeneic Anti-CD19 CAR T cells will be infused
Also known as: Allogeneic Anti-CD19 CAR T cells
Safety and efficacy outcomes
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards；Efficacy assessments: Relapsed refractory systemic lupus erythematosus-SLE Response Index 4 (SRI-4) response;Sjögren's Syndrome with relapsed refractory thrombocytopenia-assessment of treatment response for thrombocytopenia(CR, PR, NR);Relapsed refractory/progressive systemic sclerosis-Composite Response Index in Systemic Sclerosis(CRISS);Relapsed refractory/progressive inflammatory myopathy-Total Improvement Score (TIS);Relapsed refractory ANCA-associated vasculitis-BVAS score;Recurrent Refractory/Catastrophic Antiphospholipid Syndrome-new thrombosis
Time frame: First 30 days for DLT, 3 months for safety and efficacy measurements during the treatment assessment period, and then follow-up every 3 months for up to a year after the treatment.
PK parameters
Changes in the CAR gene copy number and CAR-T cell count in peripheral blood and duration after infusion of BRL-301; time to peak (Tmax), peak concentration (Cmax), area under the concentration-time curve from 0 to 1 month (AUC0-M1), and from 0 to 3 months (AUC0-M3)
Time frame: 3 months
PD parameters
Changes in cytokines in peripheral blood after infusion of BRL-301
Time frame: 3 months
Plan to share: No
No publications or documents are linked to this record.
Ran from May 2023 to primary completion in May 2024, 12 months.
Of 129 interventional studies with no phase under Lupus Erythematosus, Systemic, half reached primary completion within 23 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 38. This study's 12 months is below that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
No contact was published for this record. The registry link below has the sponsor’s details.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: BRL-301
Lupus Erythematosus, Systemic →