NCT06839976 CD19-Directed Chimeric Antigen Receptor Autologous T Cells (CART19) for Lupus

Trial Parameters

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Brief 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.

Eligibility Criteria

Inclusion Criteria: 1. 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. 2. Patient age must be 12-29 years, inclusive, at time of enrollment. 3. Meeting ACR/EULAR Classification Criteria for SLE 4. ANA positive \> 1:80 and/or double-stranded DNA (dsDNA) positive 5. Active (refractory) disease, defined as follows: a. Lupus nephritis subjects must meet both the following criteria: i. ISN/RPS active nephritis Class III/IV +/- V lupus nephritis diagnosed by biopsy within past 12 months. ii. Persistent and clinically significant: ≥2 measurements with urine protein with either of the following: 1. \> 1mg/mg creatinine 2. \> 0.5 mg/mg creatinine associated with renal dysfunction or low albumin. 3. \> 0.5 mg/mg creatinine in a patient with rising proteinuria after prior complete renal response b. Non-renal SLE subjects must meet

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