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A Phase 1 Study of Prulacabtagene Leucel (Prula-cel, Formerly ADI-001) in Autoimmune Disease

StatusEnrolling by Invitation
PhasePhase 1
Started
View on ClinicalTrials.gov ↗

Record History

See every version on ClinicalTrials.gov ↗

  1. Trial status: Recruiting to Enrolling by Invitation
    • Eligibility criteria expanded, about 1,145 words
    • Site details revised at 2 of 2 sites
    • Study title expanded, about 4 words
    v7
  2. Study sites: 1 to 2v6
  3. Study site revisedv5
  4. Enrollment target: 40 to 180
    • Start date changed from estimate of Nov 2024 to Nov 10, 2024
    • Eligibility criteria expanded, about 652 words
    • Study title revised
    v4
  5. Trial status: Not Yet Recruiting to Recruiting
    • Start date: Jun 2024 to Nov 2024
    • Study sites: 0 to 1
    v3
  6. Eligibility criteria revisedv2
  7. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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.
Adicet Therapeutics
5 trials monitored
See 1 trial at risk
Lupus (SLE)
666 trials monitored
See 25 trials at risk
Scleroderma
324 trials monitored
See 13 trials at risk
ADI-202300103 is a phase 1 multicenter, open label, dose finding and dose expansion, safety/efficacy study in patients with autoimmune disease. The study will consist of different periods including screening, lymphodepletion, treatment, and follow-up
Trial Details
NCT Number NCT06375993
Lead Sponsor Adicet Therapeutics
Conditions
(from sponsor)		 Lupus Nephritis, Autoimmune Diseases, Systemic Sclerosis (SSc), Systemic Lupus Erythematosus (SLE), ANCA-Associated Vasculitis (AAV), Idiopathic Inflammatory Myopathies, Stiff Person Syndrome
Related terms Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis, Autoimmune Diseases, Lupus Erythematosus, Systemic, Lupus Nephritis, Myositis, Scleroderma, Systemic, Stiff-Person Syndrome
Enrollment 180 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov