Status:
RECRUITING
Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome
Lead Sponsor:
Bangdong Gong
Conditions:
Primary Sjogren's Syndrome
Lymphoma
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
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 eva...
Detailed Description
The dose escalation method adopts the i3+3 design, and CAR-NK cells are tentatively given three doses based on literature: 5 × 10\^6/kg body weight, 1 × 10\^7/kg body weight, and 5 × 10\^7/kg body wei...
Eligibility Criteria
Inclusion
- Age range of 18-70 years old, gender not limited;
- Diagnosed with primary Sjogren's syndrome, meeting the 2016 ACR/EULAR classification criteria;
- Persistent enlargement of salivary glands, lymph nodes, liver, or spleen (imaging/or pathology), and at least 2 of the following 4 conditions are met: ① Cryoglobulinemia; ② Low C4; ③ Decreased white blood cells; ④ Positive for anti SSA or anti SSB;
- Liver and kidney function, defined as S serum GPT\<3 times the upper limit of normal; Serum bilirubin and alkaline phosphatase are less than twice the upper limit of normal, and serum creatinine is ≤ 2mg/dl;
- Normal cognitive function and voluntarily participate in this clinical trial. Signing a written informed consent form. Can follow and complete all trial procedures.
Exclusion
- Pregnant and lactating women;
- Patients with hepatitis B, hepatitis C, HIV and other virus infections;
- Highly allergic constitution or history of severe allergies;
- Patients with a history of other autoimmune diseases;
- Patients with severe heart failure, respiratory failure, liver dysfunction, kidney failure, persistent bleeding, malignant tumors, and diabetes insipidus;
- There are other situations where the researcher deems it inappropriate to participate in this clinical study.
Key Trial Info
Start Date :
February 28 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 31 2027
Estimated Enrollment :
6 Patients enrolled
Trial Details
Trial ID
NCT06967038
Start Date
February 28 2025
End Date
October 31 2027
Last Update
May 13 2025
Active Locations (1)
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1
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, China, 200065