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Clinical trial Recruiting at 1 site Phase1; Phase2 Interventional Ages 18 to 70

CAR-NK cell therapy for lymphoma patients with primary Sjogren's syndrome

Official title: Phase Ⅰ-Ⅱa Clinical Study of Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome

Run by Shanghai Tongji Hospital, Tongji University School of Medicine · NCT06967038 · Data updated 2026-11-12

This study is testing a new CAR-NK cell therapy to see if it can help high-risk lymphoma patients who also have primary Sjogren's syndrome feel better and reduce their lymphoma risk.

More Lymphoma trials

Quick facts

PhasePhase1; Phase2
Study typeInterventional
Ages18 Years to 70 Years
SexAll
Enrollment6 (estimated)
SponsorShanghai Tongji Hospital, Tongji University School of Medicine
Academic / other
Locations1 site (Shanghai, Shanghai Municipality)
StatusRecruiting
StartedFebruary 28, 2025
Main results expectedOctober 31, 2027
Study endsOctober 31, 2027
Registry record updatedMay 13, 2025
Trial IDNCT06967038 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a good fit

Ideal candidates are adults aged 18-70 diagnosed with primary Sjogren's syndrome and high-risk lymphoma.

Probably not a fit

Patients who are pregnant, have severe allergies, or are infected with hepatitis B, hepatitis C, or HIV may not benefit from this study.

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the safety and efficacy of chimeric antigen receptor natural killer (CAR-NK) cell therapy in high-risk lymphoma patients who also have primary Sjogren's syndrome. The study employs a dose escalation approach using an i3+3 design to determine the optimal dosage of CAR-NK cells, with doses ranging from 5 × 10^6 to 5 × 10^7 cells per kg of body weight. Participants will be monitored for dose limiting toxicities and efficacy, which includes assessing reductions in lymphoma risk and improvements in symptoms like dry mouth and eyes. The trial aims to enroll 6-12 subjects and will adjust dosages based on safety and tolerability data.

Why it matters

Potential benefit: If successful, this therapy could provide a novel treatment option for patients suffering from both high-risk lymphoma and primary Sjogren's syndrome.

How similar studies have gone: While CAR-NK cell therapy is a novel approach, similar studies have shown promise in treating other cancers, suggesting potential for success in this context.

Who can join: the full rules

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Age range of 18-70 years old, gender not limited;
2. Diagnosed with primary Sjogren's syndrome, meeting the 2016 ACR/EULAR classification criteria;
3. 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;
4. 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;
5. Normal cognitive function and voluntarily participate in this clinical trial. Signing a written informed consent form. Can follow and complete all trial procedures.

Exclusion Criteria:

1. Pregnant and lactating women;
2. Patients with hepatitis B, hepatitis C, HIV and other virus infections;
3. Highly allergic constitution or history of severe allergies;
4. Patients with a history of other autoimmune diseases;
5. Patients with severe heart failure, respiratory failure, liver dysfunction, kidney failure, persistent bleeding, malignant tumors, and diabetes insipidus;
6. There are other situations where the researcher deems it inappropriate to participate in this clinical study.

Where it's running

  • Tongji Hospital of Tongji University
    Shanghai, Shanghai Municipality, China     Recruiting

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
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Lymphoma 394Shanghai Tongji Hospital, Tongji University School of Medicine 7
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.