SLE (Systemic Lupus)Phase 1NCT06150651
Safety of PiggyBac Transposon CAR T-cells Targeting CD-19 in Refractory Lupus.
A Phase 1 study testing PiggyBac Transposon-Mediated CD19 CAR-T Therapy in people with SLE (Systemic Lupus), run by Chulalongkorn University at 1 site in Thailand.
Trial summary
A Phase 1 clinical trial to evaluate the safety and efficacy of PiggyBac transposon-mediated Chimeric Antigen Receptor(CAR) T-cells targeting CD19 in refractory Systemic Lupus Erythematosus (SLE) patients who have not responded to standard immunosuppressive treatments. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- SLE (Systemic Lupus)
- What is being tested?
- PiggyBac Transposon-Mediated CD19 CAR-T Therapy
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 3 participants
- Where
- 1 siteThailand
- Study dates
- 1 Dec 2023to 1 Mar 2026
- 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 18 and 60 years.
- Diagnosis of Systemic Lupus Erythematosus (SLE), as defined by the American College of Rheumatology (ACR) 1997 criteria, The Systemic Lupus International Collaborating Clinics (SLICC) criteria, or the European Alliance of Associations for Rheumatology (EULAR)/ACR classification.
- Refractory SLE, defined by one or more of the following:
- 3.1 Persistently active SLE requiring ongoing maintenance therapy (if not contraindicated) with:
- Antimalarial drug.
- Either mycophenolate (minimum daily dose of 1500 mg) or azathioprine (minimum daily dose of 1.5 mg/kg).
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- Patients must also need a minimum daily dose of 7.5 mg prednisolone for lower disease activity maintenance, or have a SLEDAI score of 8 or higher.
- 3.2 Biopsy-proven proliferative lupus nephritis after two standard induction therapies, including intravenous cyclophosphamide (cumulative dose of at least 1.5 g) and mycophenolate mofetil (administered for a minimum of 3 months), unless contraindicated.
- 3.3 Worsening of biopsy-proven lupus nephritis (activity index > 6 and chronicity index < 6 within 6 months), indicated by increased proteinuria and/or decreased estimated glomerular filtration rate, despite treatment with high-dose corticosteroids (prednisolone at least 0.7 mg/kg/day or equivalent) and either mycophenolate mofetil or cyclophosphamide for a minimum of 14 days.
- Ability to understand and willingness to sign a written informed consent document.
- Participants of child-bearing or child-fathering potential must agree to practice birth control from enrollment until four months after receiving CAR T-cell infusion.
Who cannot join
- Pregnant or breastfeeding women.
- History of active malignancy, excluding non-melanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
- History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, cirrhosis, or psychiatric illness/social situations that limit compliance with study requirements.
- 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 research procedure, or the evaluation of safety and efficacy.
- Serologic status indicating active HIV, hepatitis B, or C infection. Participants positive for hepatitis B core antibody, hepatitis B surface antigen, or hepatitis C antibody must have a negative PCR prior to enrollment.
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- History of severe adverse drug reaction to Cyclophosphamide or Fludarabine.
- Received a live vaccine within 30 days prior to CAR-T cell infusion.
- eGFR CKD-EPI < 30 ml/min/1.73m^2.
- Participation in other clinical investigations during the study period.
- Prior receipt of CAR-T cell therapy outside this protocol.
Trial locations and contacts
1 site in 1 country.
Thailand1 site
King Chulalongkorn Memorial Hospital
Bangkok, Please Select, 10330
About this study
Official title: Safety/Phase I Study of PiggyBac Transposon Mediated Chimeric Antigen Receptor T Cells Targeting CD-19 in Thai Patients With Refractory Systemic Lupus Erythematosus
A Phase 1 clinical trial to evaluate the safety and efficacy of PiggyBac transposon-mediated Chimeric Antigen Receptor(CAR) T-cells targeting CD19 in refractory Systemic Lupus Erythematosus (SLE) patients who have not responded to standard immunosuppressive treatments.
Read the detailed description
This is a single-institution phase I study in adults with refractory SLE. Autologous Peripheral Blood Mononuclear Cells will be transduced with a chimeric antigen receptor targeting the B-cell surface antigen CD19 using the PiggyBac Transposon system. Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide, followed by the infusion of 1x10^6 cells/kg CD-19 CAR T-cells. Subjects will be evaluated post-treatment for toxicity, SLE disease activity, and the persistence of CAR-expressing T cells in vivo.
- Conditions
- SLE (Systemic Lupus)
- Being tested
- PiggyBac Transposon-Mediated CD19 CAR-T Therapy
- 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.
PiggyBac Transposon-Mediated CD19 CAR-T TherapyOther
PiggyBac Transposon-Mediated CD19 CAR-T Therapy (1-2 x 10^6 cells/kg)
| Study group | Role | What they receive |
|---|---|---|
| CAR T-cell therapy | Experimental | Subjects will receive a conditioning lymphodepletion chemotherapy regimen consisting of fludarabine and cyclophosphamide, followed by an infusion of CD19 CAR-T cells at doses of 1 × 10⁶ cells/kg (n = 3) and 2 × 10⁶ cells/kg (n = 3). Receives: Other: PiggyBac Transposon-Mediated CD19 CAR-T Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety of PiggyBac transposon-mediated CAR T-cell infusion targeting CD19 in adult patients with refractory SLE.
The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
Measured: Up to 28 days after CD-19 CAR-T cell infusion
Secondary outcomes (3)
Disease activity of SLE
The Safety of Estrogens in Lupus Erythematosus National Assessment (SELENA) - Systemic Lupus Erythematosus Disease Activity Index (SLEDAI)
Measured: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Complete response rate of lupus nephritis
Complete response defined as normal or ≤ 25% decline of estimated glomerular filtration rate (eGFR) Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) from baseline and urinary protein to creatinine index (UPCI) or 24-hour urinary protein ≤ 0.5 g/g or g/day
Measured: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Partial response rate of lupus nephritis
Partial response defined as normal or ≤25% decline of eGFR CKD-EPI from baseline and at least 50% reduction of proteinuria, with a UPCI or 24-hour urinary protein between 0.5 to 3 g/g or g/day
Measured: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2023
- Study start1 Dec 2023
- Primary completion1 Mar 2026
- Study completion1 Mar 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for SLE (Systemic Lupus)Studies of the same condition, open and under way.
- More trials run by Chulalongkorn UniversityThe sponsor's other registered studies.
- 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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Intervention: PiggyBac transposon-mediated CD-19 CAR T-cells (1x10\^6 cells/kg)
- Masking
- None (open label)
- Enrolment
- 3 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chulalongkorn University
- Sponsor type
- University, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, Health Systems Research Institute,Thailand
- Responsible party
- Principal investigator, Wonngarm Kittanamongkolchai, MD, Chulalongkorn University
- Investigators
- Wonngarm Kittanamongkolchai, MD, Principal investigator, Chulalongkorn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06150651
- Sponsor's protocol ID
- SLE-PB-CD19-CART
- Status last verified
- Mar 2026
- First submitted
- 13 Nov 2023
- Last updated
- 23 Mar 2026
- 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 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Safety/Phase I Study of PiggyBac Transposon Mediated Chimeric Antigen Receptor T Cells Targeting CD-19 in Thai Patients With Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06150651
- Acronym / sponsor ID
- SLE-PB-CD19-CART
- Conditions
- SLE (Systemic Lupus)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 3 participants (actual)
- Lead sponsor
- Chulalongkorn UniversityUniversity, hospital or other
- Collaborators
- King Chulalongkorn Memorial Hospital, Health Systems Research Institute,Thailand
- Study start
- 1 Dec 2023 (actual)
- Primary completion
- 1 Mar 2026 (actual)
- Study completion
- 1 Mar 2026 (actual)
- First posted
- 29 Nov 2023 (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.
A Phase 1 clinical trial to evaluate the safety and efficacy of PiggyBac transposon-mediated Chimeric Antigen Receptor(CAR) T-cells targeting CD19 in refractory Systemic Lupus Erythematosus (SLE) patients who have not responded to standard immunosuppressive treatments.
Detailed description
This is a single-institution phase I study in adults with refractory SLE. Autologous Peripheral Blood Mononuclear Cells will be transduced with a chimeric antigen receptor targeting the B-cell surface antigen CD19 using the PiggyBac Transposon system. Subjects will receive a conditioning lymphodepletion chemotherapy regimen of fludarabine and cyclophosphamide, followed by the infusion of 1x10^6 cells/kg CD-19 CAR T-cells. Subjects will be evaluated post-treatment for toxicity, SLE disease activity, and the persistence of CAR-expressing T cells in vivo.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Intervention: PiggyBac transposon-mediated CD-19 CAR T-cells (1x10^6 cells/kg)
| Arm | Type | Receives |
|---|---|---|
| CAR T-cell therapy | Experimental | Other: PiggyBac Transposon-Mediated CD19 CAR-T TherapySubjects will receive a conditioning lymphodepletion chemotherapy regimen consisting of fludarabine and cyclophosphamide, followed by an infusion of CD19 CAR-T cells at doses of 1 × 10⁶ cells/kg (n = 3) and 2 × 10⁶ cells/kg (n = 3). |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (11 listed)
- Age between 18 and 60 years.
- Diagnosis of Systemic Lupus Erythematosus (SLE), as defined by the American College of Rheumatology (ACR) 1997 criteria, The Systemic Lupus International Collaborating Clinics (SLICC) criteria, or the European Alliance of Associations for Rheumatology (EULAR)/ACR classification.
- Refractory SLE, defined by one or more of the following:
- 3.1 Persistently active SLE requiring ongoing maintenance therapy (if not contraindicated) with:
- 3.2 Biopsy-proven proliferative lupus nephritis after two standard induction therapies, including intravenous cyclophosphamide (cumulative dose of at least 1.5 g) and mycophenolate mofetil (administered for a minimum of 3 months), unless contraindicated.
Key exclusion criteria (11 listed)
- Pregnant or breastfeeding women.
- History of active malignancy, excluding non-melanoma skin cancer and carcinoma in situ (e.g., cervix, bladder, breast).
- History of vital organ transplantation (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/bone marrow transplantation.
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, pulmonary abnormalities, cirrhosis, or psychiatric illness/social situations that limit compliance with study requirements.
- 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 research procedure, or the evaluation of safety and efficacy.
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 |
|---|---|---|
| PiggyBac Transposon-Mediated CD19 CAR-T TherapyPiggyBac Transposon-Mediated CD19 CAR-T Therapy (1-2 x 10^6 cells/kg) | Other | CAR T-cell therapy |
Primary outcome
Safety of PiggyBac transposon-mediated CAR T-cell infusion targeting CD19 in adult patients with refractory SLE.
Time frame: Up to 28 days after CD-19 CAR-T cell infusion
The incidence of adverse events assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (NCI CTCAE), Version 5.0
3 secondary outcomes
Disease activity of SLE
Time frame: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Complete response rate of lupus nephritis
Time frame: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Partial response rate of lupus nephritis
Time frame: 3, 6, and 12 months after CD-19 CAR-T cell infusion
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- 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. This study is not recruiting at the moment.
Wonngarm Kittanamongkolchai, MD principal investigator
Chulalongkorn University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing PiggyBac Transposon-Mediated CD19 CAR-T Therapy in people with SLE (Systemic Lupus), run by Chulalongkorn University at 1 site in Thailand.
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 11 inclusion and 11 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: finished, as of the sponsor's last update on 23 Mar 2026. 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 Thailand. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety of PiggyBac transposon-mediated CAR T-cell infusion targeting CD19 in adult patients with refractory SLE. (time frame: Up to 28 days after CD-19 CAR-T cell 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 23 Mar 2026.