CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus (NCT06839976) | Clinical Trial Compass
RecruitingPhase 1/2
CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus
United States24 participantsStarted 2025-05-06
Plain-language summary
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.
Who can participate
Age range12 Years – 29 Years
SexALL
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Inclusion 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:
✓. \> 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 subjects must meet either of the following criteria: i. SLEDAI-2K ≥ 8 and clinical SLEDAI-2K ≥ 6 ii. Inability to decrease prednisone ≤7.5mg/day or 0.15mg/kg/day, whichever is lower, due to active disease.
Exclusion criteria
What they're measuring
1
Frequency of the dose limiting toxicities of CART19
✕. 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