CAR-NK cell therapy for lymphoma patients with primary Sjogren's syndrome
Phase Ⅰ-Ⅱa Clinical Study of Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome
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.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 6 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | All |
| Sponsor | Shanghai Tongji Hospital, Tongji University School of Medicine Academic / other |
| Locations | 1 site (Shanghai, Shanghai Municipality) |
| Trial ID | NCT06967038 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18-70 diagnosed with primary Sjogren's syndrome and high-risk lymphoma.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai, Shanghai Municipality
- Tongji Hospital of Tongji University — Shanghai, Shanghai Municipality, China (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.