Actively Recruiting
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
Led by Children's Hospital of Philadelphia · Updated on 2026-02-23
24
Participants Needed
1
Research Sites
251 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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). There is no planned dose escalation, but a dose de-escalation will be made based on the incidence of Dose Limiting Toxicities. Phase 2 will evaluate the efficacy and further evaluate the safety of CART19 in this population.
CONDITIONS
Official Title
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent form must be obtained prior to any study procedure
- Age between 12 and 29 years at enrollment
- Must meet ACR/EULAR Classification Criteria for SLE
- Positive ANA > 1:80 and/or positive double-stranded DNA (dsDNA) test
- Active refractory disease: For lupus nephritis, biopsy-proven ISN/RPS Class III/IV +/- V nephritis within past 12 months plus persistent proteinuria meeting specific thresholds; for non-renal SLE, SLEDAI-2K score ≥ 8 with clinical score ≥ 6 or inability to reduce prednisone below specified dose due to active disease
- At least 3 months of prior conventional therapy including immunosuppressive induction agents and at least one additional therapy such as B-cell biologics or calcineurin inhibitors
- Adequate organ function: eGFR ≥ 30 without dialysis; liver enzymes < 5x upper limit normal; cardiac function with shortening fraction > 28% and ejection fraction > 45%; pulmonary reserve with dyspnea ≤ Grade 1 and hypoxia < Grade 3 when appropriate
- Participants of reproductive potential must agree to use acceptable birth control methods
You will not qualify if you...
- Active, untreated infections
- HIV infection
- Active hepatitis B with positive surface antigen
- Active hepatitis C
- Severe neuropsychiatric lupus or neurological SLE manifestations such as stroke, seizures, psychosis, demyelinating syndromes, organic brain syndrome, or lupus-related headaches
- Known monogenic lupus
- Previous autologous or allogeneic stem cell transplant
- Previous kidney transplant
- History of seizure disorder
- On anti-epileptic therapy
- Participation in another clinical trial with investigational drug within 5.5 half-lives prior to enrollment
- Unwilling or unable to stop immunosuppressive medications at CART19 infusion
- Any comorbidity judged by investigators to impair therapy tolerance
- Pregnancy
- Lactating and unwilling to stop breastfeeding
- Unwillingness to consent to long-term follow-up
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States, 19104
Actively Recruiting
Research Team
C
Caitlin Elgarten, MD
CONTACT
M
Melissa Varghese
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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