Study of Anitocabtagene Autoleucel in Participants With Non-Oncology Plasma Cell-Related Diseases

StatusRecruiting
PhasePhase 1
Started

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Trial flagged as At Risk
Primary completion moved at least 1 year 6 months later Mar 2027 → Oct 2028
Primary endpoints added 2 → 5 primary endpoints
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Record History

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  1. Primary and study completion dates pushed to Oct 2028 Show 9 more changesShow less
    • Primary endpoint(s) modified
    • Sponsor changed: Arcellx, Inc. to Kite, A Gilead Company
    • Interventions modified
    • Trial arms changed: 1 → 2
    • Study sites: 13 to 14
    • Eligibility criteria expanded, about 34 words
    • Secondary endpoints: 11 to 14
    • Study description shortened, about 82 words
    • Study title shortened, about 6 words
  2. Study sites: 9 to 13v4
  3. Study sites: 1 to 9
    • Start date changed from estimate of Jan 2025 to Apr 30, 2025
    v3
  4. Trial status: Not Yet Recruiting to Recruiting
    • Study sites: 0 to 1
    v2
  5. Study First Submitted
  • 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.
The goal of this clinical study is to learn more about the study drug Anitocabtagene autoleucel (anito-cel), and its safety, tolerability, dosing, and preliminary effectiveness in participants with generalized myasthenia gravis (GMG). Anito-cel is a B-cell maturation antigen (BCMA)-directed CAR-T cell therapy. The primary objective of this study is to assess the safety profile, including any dose-limiting toxicity (DLT) and identification of a maximum tolerated dose (MTD) (if applicable), to support selection of the recommended Phase 2 dose (RP2D) of anito-cel when administered to participants with GMG.
Trial Details
NCT Number NCT06626919
Lead Sponsor Kite, A Gilead Company
Conditions
(from sponsor)		 Muscular Diseases, Neuromuscular Manifestations, Autoimmune, Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Myasthenia Gravis, Muscle Weakness
Related terms Autoimmune Diseases, Autoimmune Diseases of the Nervous System, Muscle Weakness, Muscular Diseases, Myasthenia Gravis, Neuromuscular Manifestations
Enrollment 30 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov