Actively Recruiting
Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome
Led by Bangdong Gong · Updated on 2025-05-13
6
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This study is a phase I-II clinical trial of CAR-NK cell therapy for high-risk lymphoma patients with primary Sjogren's syndrome (pSS). The aim is to determine the optimal dose of CAR-NK cells and evaluate the safety and efficacy of increasing doses of iC9/CAR19/IL15 CB-NK cell therapy. Use i3+3 based design to increase dosage. Dose limiting toxicity (DLT) is defined as the occurrence of CRS within 2 weeks after cell infusion, requiring transfer to the intensive care unit, or grade III-IV acute graft-versus-host disease within 40 days after infusion, or grade 3-5 allergic reactions related to CAR-NK cell infusion. For the purpose of i3+3 design, efficacy is defined as a reduction in the high-risk of lymphoma in pSS patients and at least partial relief of dry mouth and eye symptoms on the 30th day after CAR-NK cell infusion.
CONDITIONS
Official Title
Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age between 18 and 70 years old, any gender
- Diagnosed with primary Sjogren's syndrome according to 2016 ACR/EULAR criteria
- Persistent enlargement of salivary glands, lymph nodes, liver, or spleen confirmed by imaging or pathology
- At least two of the following: cryoglobulinemia, low C4, decreased white blood cells, positive for anti SSA or anti SSB antibodies
- Liver and kidney function within specified limits (serum GPT less than 3 times upper normal limit; bilirubin and alkaline phosphatase less than 2 times upper normal limit; serum creatinine ≤ 2 mg/dl)
- Normal cognitive function and able to voluntarily participate and complete trial procedures with informed consent
You will not qualify if you...
- Pregnant or breastfeeding women
- Infection with hepatitis B, hepatitis C, HIV, or other viruses
- History of severe allergies or highly allergic constitution
- History of other autoimmune diseases
- Severe heart failure, respiratory failure, liver dysfunction, kidney failure, persistent bleeding, malignant tumors, or diabetes insipidus
- Any other condition deemed unsuitable for participation by the researcher
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065
Actively Recruiting
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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