CT1190B in the Treatment of Patients With Moderate to Severe Refractory Systemic Lupus Erythematosus (SLE) or Refractory/Progressive Systemic Sclerosis (SSc)

Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-60
SponsorBeijing GoBroad Hospital

About this trial

A Clinical Study Exploring CT1190B in the treatment of patients with moderate to severe refractory systemic lupus erythematosus (SLE) or refractory/progressive systemic sclerosis (SSc)

Eligibility criteria

Qualifiers

Voluntary signing of the Informed Consent Form (ICF)

Age range: At the time of signing the ICF, the age is between 18 and 60 years old (including 18 and 60 years old), regardless of gender.

No systemic active infection within 2 weeks before screening.

Contraceptive requirements for participants with child - bearing potential.

Disqualifiers

Previous history of CAR-T cell or other genetically modified T-cell therapies, or previous major organ transplantation.

Use of B-cell targeted drugs (such as rituximab) within 2 months before screening.

Allergy or intolerance to lymphodepletion drugs, tocilizumab, or life-threatening allergic reactions, hypersensitivity reactions, or intolerance to the CT1190B preparation or its excipients, or a history of other severe allergies such as anaphylactic shock.

Use of corticosteroids ≥ 10 mg/day of prednisone (or equivalent drug) within 10 days before the infusion of CT1190B.

Trial design

Treatments tested in this trial

  • CAR-T Therapy

Treatment groups

27 Participants
are divided into 1 treatment group

Sponsors and collaborators

Beijing GoBroad Hospital

Lead sponsor

CARsgen Therapeutics Co., Ltd.

Collaborator