Clinical Study of BCT301 Cell Injection Therapy for Refractory Autoimmune Diseases

Sponsor
Peking University Third Hospital
Study ID
NCT07301164
Phase
EARLY_PHASE1
Status
Not Yet Recruiting

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Conditions

  • ANCA Associated Vasculitis
  • Antiphospholipid Syndrome
  • Inflammatory Myositis
  • Sjogren Syndrome
  • System Lupus Erythematosus
  • Systemic Sclerosis (SSc)

Eligibility Criteria

Sex
ALL
Age
18 Years - 80 Years
Healthy Volunteers
Not accepted

Interventions

  • BCT301 — BIOLOGICAL
    BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells.Participants will receive a single infusion of BCT301 cell injection at escalating dose levels.Prior to infusion, patients undergo a lymphodepleting conditioning regimen with fludarabine and cyclophosphamide given intravenously for three consecutive days.

Study Details

This study primarily involves the use of BCT301, an anti-CD19 Chemically induced pluripotent stem cell (CiPSC)-derived CAR-iT cells, for the treatment of patients with refractory autoimmune diseases, aiming to evaluate its safety, tolerability, and dose-limiting toxicities(DLT), and to determine the recommended therapeutic dose for further investigation. Additionally, the study assesses the efficacy of BCT301 cell injection in refractory autoimmune diseases, as well as the pharmacokinetic (PK) and pharmacodynamic (PD) characteristics in study participants.

Key Dates

Start date
Dec 11, 2025
Status verified
Dec 2025
Primary completion
Dec 31, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
10 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: BCT301

Primary Outcome Measure

Dose-limiting toxicities of BCT301 [ Time Frame: 28 days ]

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