BridgeMD
New treatment option for SLE
Official title CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
ClinicalTrials.gov ID: NCT06839976
What this study is testing
What is CART19?
CART19 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for sle.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a single-center, single-arm, open-label phase 1/2 study of CART19 in children and young adults with refractory Systemic lupus erythematosus (SLE), including both patients diagnosed with lupus nephritis (LN) and patients with non-renal Systemic lupus erythematosus (SLE). Phase 1 will evaluate the safety of CART19 in 6-12 patients with Systemic lupus erythematosus (SLE).
- Phase 2: a mid-size study of how well it works
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 to 29
You may be able to join if
- Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be...
- Patient age must be 12-29 years, inclusive, at time of enrollment.
- Meeting ACR/EULAR Classification Criteria for SLE
- ANA positive \> 1:80 and/or double-stranded DNA (dsDNA) positive
- Active (refractory) disease, defined as follows: a. Lupus nephritis people must meet both the following criteria: i. ISN/RPS active nephritis Class...
You likely can't join if
- Active, untreated infections
- HIV infection
- Active Hepatitis B a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.
- Active Hepatitis C
- Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic...
- Monogenic lupus (known)
See the full eligibility criteria
- Signed informed consent form must be obtained prior to any study procedure. Labs or other procedures obtained during routine clinical care may be used for eligibility if obtained within the protocol required window.
- Patient age must be 12-29 years, inclusive, at time of enrollment.
- Meeting ACR/EULAR Classification Criteria for SLE
- ANA positive \> 1:80 and/or double-stranded DNA (dsDNA) positive
- Active (refractory) disease, defined as follows: a. Lupus nephritis people must meet both the following criteria: i. ISN/RPS active nephritis Class III/IV +/- V lupus nephritis diagnosed by biopsy within past 12 months...
- \> 1mg/mg creatinine
- \> 0.5 mg/mg creatinine associated with renal dysfunction or low albumin.
- \> 0.5 mg/mg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE people must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii...
- Conventional induction immunosuppressive agent(s) (e.g., mycophenolate mofetil, cyclophosphamide), and
- At least one additional therapy: i. B-cell directed biologic therapy (e.g., rituximab, belimumab, ofatumumab, obinutuzumab) ii. Calcineurin inhibitor (e.g., tacrolimus, cyclosporine, voclosporin) iii. Other...
- Renal: eGFR must be ≥30 and subject cannot be receiving dialysis.
- Hepatic: Transaminases \< 5x upper limit of normal and serum conjugated (Direct) bilirubin \<1.5x upper limit of normal unless attributable to SLE. If attributable to autoimmune disease, Child-Pugh score must be class A...
- Cardiac: Shortening fraction \> 28%, left ventricular ejection fraction \>45%, and no evidence of severe pulmonary hypertension
- Pulmonary: Must have a minimum level of pulmonary reserve defined as ≤ Grade 1 dyspnea and \<Grade 3 hypoxia; DLCO ≥40% (corrected for anemia and/or VA volume if necessary) if PFTs are clinically appropriate as...
- Active, untreated infections
- HIV infection
- Active Hepatitis B a. Patients must have a negative hepatitis B surface antigen to be enrolled on this study.
- Active Hepatitis C
- Patients with severe neuropsychiatric lupus or neurologic manifestations of SLE (e.g. stroke, seizure, psychosis, demyelinating syndromes, organic brain syndrome, or lupus related headaches)
- Monogenic lupus (known)
- Previous autologous or allogenic stem cell transplant
- Previous kidney transplant
- History of seizure disorder
- Patients who are on anti-epileptic therapy
- Participation in a clinical trial in which the patient receives an investigational drug within a time period equal or less than 5.5 half-lives of the investigational agent prior to study enrollment.
- people who are unwilling or unable to discontinue immunosuppressive medications at the times of CART19 infusion will be excluded from the trial
- Any comorbidity that in the opinion of the investigators would jeopardize the ability of the subject to tolerate therapy.
- Pregnant patients. All participants of childbearing potential must have negative pregnancy test.
- Lactating participants who want to continue breastfeeding.
- Patients who are unwilling to consent to LTFU
The study team makes the final eligibility decision.
Where it's taking place
- Philadelphia, Pennsylvania, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years to 29 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Philadelphia, Pennsylvania, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.