Umbilical Cord Blood CD19-BCMA CART Cell Therapy for SLE-LN, SSc, andpSS PAH.

Sponsor
Beijing GoBroad Hospital
Study ID
NCT06947473
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

  • Primary Sjogren's Syndrome Combined With Pulmonary Hypertension
  • Refractory Lupus Nephritis
  • Systemic Sclerosis

Eligibility Criteria

Sex
ALL
Age
6 Years - 65 Years
Healthy Volunteers
Not accepted

Interventions

  • umbilical cord blood CD19-BCMA CAR-T cells infusion — DRUG
    Approximately 3-5 days prior to umbilical cord blood CD19-BCMA CAR-T cell infusion, subjects are treated with FC regimen (fludarabine and cyclophosphamide) for lymphodepletion. CAR-T cell infusion are performed 48 h after completion of chemotherapy.

Study Details

This is a single-center, open-label, non-randomized, single-arm clinical trial. Patients with refractory lupus neritis (SLE-LN), systemic sclerosis (SSc), and primary Sjogren syndrome combined with pulmonary artery hypertension (pSS-PAH receive umbilical cord blood CD19-BCMA CAR T cell therapy. The primary objective is to prospectively assess the safety of umbilical cord blood CD19BCMA CAR T cell therapy in patients with refractory lupus nephritis (SLE-LN), systemic sclerosis (SSc), and primaryjogren syndrome combined with pulmonary artery hypertension. The primary endpoint is the type and incidence of dose-limiting toxicity (DLT) within 28 days after theusion of umbilical cord blood CD19-BCMA CAR T cells. It is anticipated that 45-54 participants will be recruited.

Key Dates

Start date
Mar 18, 2026
Status verified
May 2025
Primary completion
Jul 1, 2026
Completion
Dec 31, 2027

Study Design

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

Arms

  • Experimental: umbilical cord blood CD19-BCMA CAR T cell therapy.
    Patients were treated with umbilical cord blood CD19-BCMA CAR T cell therapy.

Primary Outcome Measure

Dose-limiting toxicity (DLT) [ Time Frame: 28 days ]

Central Contacts

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