Study of CD19 CAR-T Therapy for Refractory SLE

Sponsor
Chongqing Precision Biotech Co., Ltd
Study ID
NCT07403097
Phase
PHASE1
Status
Recruiting
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Conditions

Eligibility Criteria

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

Interventions

  • PTOC1 — BIOLOGICAL
    Three dose groups (1.5×10\^5/kg, 5×10\^5/kg,1×10\^6/kg) were set up, starting from the low dose group climbing to explore the safe and effective dose.

Study Details

This is an investigator-initiated trial aimed at assessing the safety and efficacy of PTOC1 cells Injection in the treatment of refractory systemic lupus erythematosus.

Key Dates

First listed
Feb 11, 2026
Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Apr 30, 2028
Completion
Dec 31, 2028

Study Design

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

Arms

  • Experimental: PTOC1
    This trial was designed as an open, single-arm, single-center, dose-exploration trial.

Primary Outcome Measure

The safety of PTOC1 cell therapy in patients with refractory SLE [Safety] [ Time Frame: 3 months ]

Central Contacts

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