Systemic Lupus ErythematosusPhase 1/2BAH242NCT06350110
Fourth-gen CAR T Cells Targeting BCMA/CD19 for Refractory Systemic Lupus Erythematosus (SLE)
A Phase 1/2 study testing CD19- BCMA CAR-T cells in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Essen Biotech at 1 site in China.
Trial summary
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases
- What is being tested?
- CD19- BCMA CAR-T cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 10 Jul 2024to 28 Dec 2025
- Phase
- Phase 1/2
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-90 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
- SELENA-SLEDAI≥8.
- Patients with CD19+ B-cell.
- Hemoglobin≥85 g/L.
- WBC≥2.5×10^9/L.
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- NEUT≥1×10^9/L.
- BPC≥50×10^9/L.
- AST/ALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL/min; blood bilirubin ≤2.0 mg/dl; echocardiography indicates that the ejection fraction is ≥50%.
- Adequate venous access for apheresis, and no other contraindications for leukapheresis.
- Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline.
- Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.
- Agree to attend follow-up visits as required.
- Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative.
Who cannot join
- Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.
- Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis.
- Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus.
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- Patients with syphilis infection.
- The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening.
- Received live vaccine treatment within 4 weeks prior to screening.
- Severe allergies or hypersensitivity.
- Contraindication to cyclophosphamide in combination with fludarabine.
- Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion.
- Cannula or drainage tubes other than central venous catheters.
- Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;
- Subjects with prior CD19 or BCMA-targeted therapy.
- Participated in any clinical study within 3 months prior to enrollment.
- Subjects with malignant tumour, except for Non-melanoma Skin Cancer with PFS>5yr; Cervical Cancer in situ; Bladder Cancer; Breast Cancer.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
District One Hospital
Beijing, Beijing Municipality, 086-373
SAMI XI, dr, +14012275001, SFM@districtonehospital.com
About this study
Official title: T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement
This study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
Read the detailed description
Systemic lupus erythematosus (SLE) is a type of autoimmune disorder characterized by the creation of autoantibody-generating immune complexes, affecting various systems and organs.
In SLE, autoreactive B cells can self-activate and morph into plasma cells that produce a high volume of autoantibodies. These cells can also expose their own antigens to autoimmune T cells, thereby stimulating T cells and leading to the release of inflammatory substances.
Conventional treatment for SLE focuses on achieving prolonged remission. In contrast, CD19-BCMA CAR-T cells offer a potential solution by eradicating the abnormal B cells responsible for antibody production. This allows for the rebuilding of the immune system and the restoration of normal immune function in patients, potentially leading to a life free from medication. This highlights the promising potential of CAR-T therapy in treating SLE.
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatous Polyangiitis, Microscopic Polyangiitis
- Being tested
- CD19- BCMA CAR-T cells
- Keywords
- CAR-T Cell Therapy
- Medical subject headings
- Lupus Erythematosus, Systemic, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatosis with Polyangiitis, Microscopic Polyangiitis, Scleroderma, Systemic, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19- BCMA CAR-T cellsBiological
Also called EB-BH2024-2
The intervention in this clinical trial involves a novel approach using CD19/BCMA-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies.
Treatment Regimen:
Patients in the trial will undergo the following regimen:
Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy.
Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2.
CD19/BCMA-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19/BCMA-CAR T cells, over 10-20 minutes on day 0.
Additional Doses: Eligible patients responding well to the initial CD19/BCMA-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses.
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Treatment (CD19/BCMA-CAR T cells, chemotherapy) | Experimental | Treatment (CD19/BCMA-CAR T cells, chemotherapy)
Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD19/BCMA-CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD19/BCMA-CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD19/BCMA-CAR T cells. Receives: Biological: CD19- BCMA CAR-T cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined.
Measured: 28 days
Secondary outcomes (1)
Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells
satisfy the targeted dose level and meet the required release specifications outlined in the Certificate of Analysis (COA)
Measured: 10-14 days after apheresis or thawing of cryopreserved peripheral blood mononuclear cell
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start10 Jul 2024
- Primary completion10 Dec 2025 (estimated)
- Study completion28 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Systemic Lupus ErythematosusStudies 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
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single Group Assignment Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD19 and BCMA CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for the CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells. Monitoring and Follow-up: Following the CAR-T cell infusion, patients will be subjected to rigorous monitoring to assess safety and treatment response.
- Masking
- None (open label)
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Essen Biotech
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06350110
- Sponsor's protocol ID
- ESBI202492
- Acronym
- BAH242
- Status last verified
- Oct 2024
- First submitted
- 1 Apr 2024
- Last updated
- 15 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- T-cell Infusion Targeting BCMA and CD19 for Refractory/Relapsed Systemic Lupus Erythematosus (SLE) Patients With or Without Organs Involvement
- ClinicalTrials.gov ID
- NCT06350110
- Acronym / sponsor ID
- BAH242 / ESBI202492
- Conditions
- Systemic Lupus Erythematosus, Lupus Nephritis, Autoimmune Diseases, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Granulomatous Polyangiitis, Microscopic Polyangiitis
- Keywords
- CAR-T Cell Therapy
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Essen BiotechUniversity, hospital or other
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- 10 Dec 2025 (estimated)
- Study completion
- 28 Dec 2025 (estimated)
- First posted
- 5 Apr 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 study is a preliminary investigation, with a single-group design, not randomized and transparent, focusing on treatment. Its purpose is to identify the highest dose of BH002 injection (CD19-BCMA CAR-T cells) that patients suffering from resistant systemic lupus erythematosus can tolerate.
Detailed description
Systemic lupus erythematosus (SLE) is a type of autoimmune disorder characterized by the creation of autoantibody-generating immune complexes, affecting various systems and organs.
In SLE, autoreactive B cells can self-activate and morph into plasma cells that produce a high volume of autoantibodies. These cells can also expose their own antigens to autoimmune T cells, thereby stimulating T cells and leading to the release of inflammatory substances.
Conventional treatment for SLE focuses on achieving prolonged remission. In contrast, CD19-BCMA CAR-T cells offer a potential solution by eradicating the abnormal B cells responsible for antibody production. This allows for the rebuilding of the immune system and the restoration of normal immune function in patients, potentially leading to a life free from medication. This highlights the promising potential of CAR-T therapy in treating SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single Group Assignment Patients enrolled in this clinical trial will receive a carefully designed treatment regimen. Prior to the infusion of CD19 and BCMA CAR-T cells, participants will undergo preconditioning chemotherapy. This chemotherapy serves to create an optimal environment for the CAR-T cell therapy to effectively target and eliminate malignant B cells. Following chemotherapy, participants will receive the infusion of CD19 and BCMA CAR-T cells. Monitoring and Follow-up: Following the CAR-T cell infusion, patients will be subjected to rigorous monitoring to assess safety and treatment response.
| Arm | Type | Receives |
|---|---|---|
| Experimental: Treatment (CD19/BCMA-CAR T cells, chemotherapy) | Experimental | Biological: CD19- BCMA CAR-T cellsTreatment (CD19/BCMA-CAR T cells, chemotherapy) Patients will be administered fludarabine phosphate intravenously (IV) over a 30-minute period on days -4 to -2. Additionally, cyclophosphamide will be administered intravenously (IV) over 60 minutes on day -2. Subsequently, patients will receive CD19/BCMA-CAR T cells intravenously (IV) over a duration of 10-20 minutes on day 0. Patients who exhibit positive responses to the initial dose of CD19/BCMA-CAR T cells, do not experience unacceptable side effects, and have a sufficient quantity of cells available may be eligible to receive 2 or 3 additional doses of CD19/BCMA-CAR T cells. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18-90 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria.
- SELENA-SLEDAI≥8.
- Patients with CD19+ B-cell.
- Hemoglobin≥85 g/L.
Key exclusion criteria (17 listed)
- Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks --Prior to leukapheresis, or subjects who need hemodialysis.
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts.
- Patients with serious lesions and a history of present illness of vital organs such as the heart, liver,kidney blood and endocrine system.
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis.
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 |
|---|---|---|
| CD19- BCMA CAR-T cellsAlso: EB-BH2024-2The intervention in this clinical trial involves a novel approach using CD19/BCMA-Chimeric Antigen Receptor T (CAR T) cells combined with chemotherapy. The goal is to assess safety and efficacy in patients with specific hematologic malignancies. Treatment Regimen: Patients in the trial will undergo the following regimen: Fludarabine Phosphate (Days -4 to -2): IV administration of fludarabine phosphate over 30 minutes on days -4 to -2. It's part of the preparatory regimen to enhance the body's response to CAR T-cell therapy. Cyclophosphamide (Day -2): IV cyclophosphamide over 60 minutes on day -2. CD19/BCMA-Chimeric Antigen Receptor T Cells (Day 0): IV administration of investigational therapy, CD19/BCMA-CAR T cells, over 10-20 minutes on day 0. Additional Doses: Eligible patients responding well to the initial CD19/BCMA-CAR T cell infusion without unacceptable side effects and sufficient CAR T cell availability may receive 2 or 3 additional doses. | Biological | Experimental: Treatment (CD19/BCMA-CAR T cells, chemotherapy) |
Primary outcome
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells
Time frame: 28 days
Will be recorded and graded according to the Common Terminology Criteria for Adverse Events (CTCAE) version 4.03 at three dose levels until the maximum tolerated dose (MTD) is determined.
1 secondary outcome
Rate of successful manufacture and expansion of the CD19/BCMA chimeric antigen receptor (CAR) T cells
Time frame: 10-14 days after apheresis or thawing of cryopreserved peripheral blood mononuclear cell
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Oct 2024.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CD19- BCMA CAR-T cells in people with Systemic Lupus Erythematosus and Lupus Nephritis, run by Essen Biotech 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 14 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: looking for participants now, as of the sponsor's last update on 15 Oct 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.
What does this combined 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.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 Rhoda M Smith, Phd (+12077706670, clinical-trials@essen-biotech.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence and severity of dose limiting toxicities (DLTs) following chemotherapy preparative regimen and infusion of CD19/BCMA chimeric antigen receptor (CAR) T cells (time frame: 28 days). 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 15 Oct 2024.