UCAR T-cell Therapy Targeting CD19/ BCMA in Patients With Relapse/ Refractory Autoimmune Diseases

Sponsor
Changzhou No.2 People's Hospital
Study ID
NCT06978738
Phase
PHASE1
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • universal allogeneic anti-CD19/BCMA CAR T-cells — BIOLOGICAL
    A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells

Study Details

This is an investigator-initiated trial to evaluate the safety and efficacy of universal allogeneic anti-CD19/BCMA CAR T-cells in With Relapse/Refractory Autoimmune Diseases.

Key Dates

First listed
May 18, 2025
Start date
May 31, 2025
Status verified
May 2025
Primary completion
May 31, 2027
Completion
Nov 30, 2028

Study Design

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

Arms

  • Experimental: UCAR T-cell group
    A single injection of UCAR T-cells, referred to as universal allogeneic anti-CD19/BCMA CAR T-cells

Primary Outcome Measure

The number and severity of dose-limiting toxicity (DLT) events [ Time Frame: Within 28 Days After UCAR T-cell Infusion ]

Central Contacts

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