Actively Recruiting
A Single-center Study Evaluating Safety and Efficacy of Universal CD19-targeting CAR-γδ T Cells (QH103) in Refractory Autoimmune Diseases
Led by Peking University Third Hospital · Updated on 2025-08-20
9
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Autoimmune diseases include a range of conditions such as systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis, and antiphospholipid syndrome. These diseases result from the immune system attacking the body's own tissues, causing damage that can affect quality of life and sometimes be life-threatening. Current treatments involve glucocorticoids, immunosuppressants, and biologics, but researchers are exploring new therapies targeting B cells, which play a key role in these diseases. This clinical study evaluates the safety and effectiveness of universal CD19-targeting CAR-γδ T cells (QH103) as a treatment for refractory autoimmune diseases. This cell therapy uses engineered immune cells designed to target B cells involved in disease processes. The study includes adults aged 18 to 80 years with refractory autoimmune diseases who have not responded well to conventional treatments. Participants receive anti-CD19 CAR-γδ T cell therapy and are monitored closely. Participants will be followed for up to 12 months to assess safety and determine the maximum tolerated dose of the therapy within the first 28 days. Disease activity will be measured at months 3, 6, 9, and 12 using various clinical scores specific to each autoimmune condition. Researchers will also monitor immune response, pharmacokinetics, and any disease improvements. The study involves regular blood tests, imaging, and questionnaires to evaluate treatment effects and participant health throughout the trial period.
CONDITIONS
Brief Title
Safety and Efficacy of Universal CD19-targeting CAR-γδT Cells in Refractory Autoimmune Diseases
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 80 years, male or female.
- Positive CD19 expression on peripheral blood B cells.
- Diagnosed with refractory autoimmune disease unresponsive to conventional treatment for over 6 months or with disease recurrence after remission.
- Currently on stable doses of standard therapies like glucocorticoids, antimalarials, immunosuppressants, or biologics.
- Female participants of childbearing potential and male partners must use approved contraception or abstain during treatment and for 6 months after.
- Female participants must have a negative pregnancy test before enrollment and not be breastfeeding.
- Meet disease-specific criteria for systemic lupus erythematosus, Sjögren's syndrome, systemic sclerosis, inflammatory myopathies, ANCA-associated vasculitis, or refractory antiphospholipid syndrome as defined by classification and activity scores.
- Willing to participate and sign informed consent.
You will not qualify if you...
- History of severe drug allergies or allergic constitution.
- Presence or suspicion of uncontrolled fungal, bacterial, viral, or other infections.
- Central nervous system diseases including epilepsy, psychiatric disorders, organic brain syndrome, cerebrovascular accidents, encephalitis, or CNS vasculitis.
- Major organ dysfunction outside defined safe limits for bone marrow, liver, kidney, coagulation, or cardiac function.
- Congenital immunoglobulin deficiencies.
- History of malignancy within the past five years.
- Positive hepatitis B, hepatitis C, HIV, or syphilis tests with active infection.
- Psychiatric disorders or severe cognitive impairment.
- Participation in other clinical trials within 3 months prior.
- Previous CAR-T therapy.
- History of severe reactions to cyclophosphamide or fludarabine.
- Any other condition that investigators determine makes participation unsuitable.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 28 days
Participants receive anti-CD19 CAR-γδ T cell therapy to assess safety and efficacy in treating refractory autoimmune diseases.
1 treatment visit followed by multiple monitoring visits during treatment
Duration - Up to 12 months
Participants are monitored for efficacy and safety outcomes for up to 12 months after treatment.
Visits at Month 3, 6, 9, and 12 for assessments
Trial Site Locations
Total: 1 location
1
Peking University Third Hospital
Beijing, China
Actively Recruiting
Research Team
X
Xiaoying Zhang
X
Xiaoying Zhang
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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