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

StatusRecruiting
PhasePhase 1/2
Started
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Record History

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  1. Lead sponsor: Children's Hospital of Philadelphia to Children's Hospital of Philadelphia
    • Eligibility criteria expanded, about 30 words
    • Secondary endpoints revised (9)
    • Site details revised
  2. Re-verified, no change to tracked fieldsv9
  3. Eligibility criteria shortened, about 7 wordsv8
  4. Re-verified, no change to tracked fieldsv7
  5. Eligibility criteria shortened, about 138 wordsv6
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  1. Start date changed from estimate of May 30, 2025 to May 6, 2025v5
  2. Start date: Mar 31, 2025 to May 30, 2025v4
  3. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Mar 5, 2025 to Mar 31, 2025
    • Site details revised
    v3
  4. Start date: Feb 28, 2025 to Mar 5, 2025v2
  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT06839976
Lead Sponsor Children's Hospital of Philadelphia
Conditions
(from sponsor)		 SLE, Systemic Lupus Erythematosus (SLE), CAR T Cell, CART19, Cell Therapy, Lupus, Lupus Nephritis (LN)
Related terms Lupus Erythematosus, Systemic, Lupus Nephritis
Enrollment 24 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov