Lupus NephritisEarly Phase 1NCT06681337
Universal CAR-T Cell Therapy for Refractory Lupus Nephritis
A Early Phase 1 study testing BCMA CART + CD19 CART in people with Lupus Nephritis, run by Bioray Laboratories.
Trial summary
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- BCMA CART + CD19 CART
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- No sites listed yet
- Study dates
- 25 Nov 2024to Dec 2025
- Phase
- Early 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
- Aged 18-65 years; both genders eligible.
- Subjects diagnosed with lupus nephritis.
- Previous treatment outcomes were unsatisfactory.
- Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
- NIH Activity Index > 2 and elevated chronicity index.
- Urine protein: creatinine ratio (UPCR) ≥ 1.0 g/g, or 24-hour urine protein ≥ 1.0 g, with or without active urine sediment with red blood cell casts.
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- Receiving hormones with or without antimalarials.
- SLEDAI-2K score ≥ 6.
- Antinuclear antibody positive, and/or anti-ds-DNA antibody positive, and/or anti-Smith antibody positive.
- Positive expression of CD19 on B cells in peripheral blood.
- Agrees to use double barrier methods, condoms, oral or injectable contraceptives, or intrauterine devices during the study period and for one year after taking the study medication.
- Provides written informed consent.
Who cannot join
- History of solid organ transplantation.
- Malignant tumor within the last two years.
- Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- Primary immunodeficiency (congenital or acquired).
- Severe cardiac disease.
- History of psychiatric disorders or history of psychotropic drug abuse, with no history of withdrawal.
- Allergic constitution or a history of severe allergies.
- Pregnant or breastfeeding women.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.
Read the detailed description
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.
- Conditions
- Lupus Nephritis
- Being tested
- BCMA CART + CD19 CART
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BCMA CART + CD19 CARTBiological
BCMA CART + CD19 CART
| Study group | Role | What they receive |
|---|---|---|
| BCMA CART + CD19 CART | Experimental | BCMA CART + CD19 CART Receives: Biological: BCMA CART + CD19 CART |
What is being measured
The primary outcome is the main question the study is designed to answer.
AEs
The total number, incidence, and severity of AE
Measured: Within 6 months after BCMA CART and CD19 CART infusion
Secondary outcomes (1)
ORR (CR and PR)
Complete response (CR) was defined as serum creatinine ≤ 1.2 mg/dl or ≤ 125% of baseline value, and urine protein/creatinine ratio < 0.5 or 24-hour urine protein quantification < 0.5 g, and prednisone dose reduction to ≤ 10 mg/d (or equivalent dose). Partial response (PR) was defined as if both serum creatinine and urine protein/creatinine ratio (or 24-hour urine protein quantification) were abnormal before treatment, both items improved by > 30% after treatment, without other indicators of deterioration; if only urine protein/creatinine ratio (or 24-hour urine protein quantification) was abnormal before treatment, the improvement was > 50% after treatment.
Measured: At 6 months after BCMA CART and CD19 CART infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Nov 2024
- Study start25 Nov 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bioray Laboratories
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06681337
- Sponsor's protocol ID
- 2024-BRL-302-03
- Status last verified
- Sep 2024
- First submitted
- 4 Nov 2024
- Last updated
- 8 Nov 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Clinical Study of the Safety and Efficacy of Universal CAR-T Cells Targeting BCMA and CD19 for the Treatment of Refractory Lupus Nephritis
- ClinicalTrials.gov ID
- NCT06681337
- Acronym / sponsor ID
- 2024-BRL-302-03
- Conditions
- Lupus Nephritis
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Bioray LaboratoriesIndustry (pharma, biotech, devices)
- Collaborators
- The Affiliated Nanjing Drum Tower Hospital of Nanjing University Medical School
- Study start
- 25 Nov 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 8 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This investigator-initiated trial aims to assess the efficacy and safety of combination therapy using universal CAR-T cells targeting BCMA and CD19 in refractory lupus nephritis.
Detailed description
This study is a non-randomized, open-label, single-arm clinical trial designed to assess the efficacy and safety of combination therapy for refractory lupus nephritis using universal CAR-T cells targeting BCMA and CD19.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BCMA CART + CD19 CART | Experimental | Biological: BCMA CART + CD19 CARTBCMA CART + CD19 CART |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Aged 18-65 years; both genders eligible.
- Subjects diagnosed with lupus nephritis.
- Previous treatment outcomes were unsatisfactory.
- Diagnosis of active nephritis type III or IV with or without type V according to 2018 International Society of Nephrology and Society of Renal Pathology (ISN/RPS) criteria.
- NIH Activity Index > 2 and elevated chronicity index.
Key exclusion criteria (8 listed)
- History of solid organ transplantation.
- Malignant tumor within the last two years.
- Positive for Hepatitis B surface antigen (HBsAg) or Hepatitis B core antibody (HBcAb), with peripheral blood Hepatitis B virus (HBV) DNA detected as positive; positive for Hepatitis C virus antibodies, with peripheral blood Hepatitis C virus RNA detected as positive; positive for Human Immunodeficiency Virus (HIV) antibodies; positive for Cytomegalovirus (CMV) DNA; positive for syphilis.
- Primary immunodeficiency (congenital or acquired).
- Severe cardiac disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BCMA CART + CD19 CARTBCMA CART + CD19 CART | Biological | BCMA CART + CD19 CART |
Primary outcome
AEs
Time frame: Within 6 months after BCMA CART and CD19 CART infusion
The total number, incidence, and severity of AE
1 secondary outcome
ORR (CR and PR)
Time frame: At 6 months after BCMA CART and CD19 CART infusion
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing BCMA CART + CD19 CART in people with Lupus Nephritis, run by Bioray Laboratories.
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 12 inclusion and 8 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 8 Nov 2024. Status can change between updates, so confirm with the study contact before making plans.
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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Dandan Wang, PhD (15850515316, dangdangwang2007@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
AEs (time frame: Within 6 months after BCMA CART and CD19 CART infusion). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2024.