RecruitingPhase 1Phase 2NCT06967038

Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk 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


Sponsor

Bangdong Gong

Enrollment

6 participants

Start Date

Feb 28, 2025

Study Type

INTERVENTIONAL

Conditions

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 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.


Eligibility

Min Age: 18 YearsMax Age: 70 Years

Plain Language Summary

Simplified for easier understanding

This study is testing CAR-NK cell therapy — a cutting-edge treatment that uses genetically engineered immune cells (natural killer cells) — for people with primary Sjogren's syndrome who have developed high-risk lymphoma (a type of blood cancer). **You may be eligible if...** - You are between 18 and 70 years old - You have a confirmed diagnosis of primary Sjogren's syndrome (a chronic autoimmune condition affecting moisture-producing glands) - You have persistent enlarged salivary glands, lymph nodes, liver, or spleen — and at least two of: cryoglobulinemia, low C4 levels, low white blood cell count, or positive anti-SSA/SSB antibodies - Your liver and kidney function meets the required thresholds **You may NOT be eligible if...** - You have significant other autoimmune conditions beyond primary Sjogren's - You have active uncontrolled infections - You have serious organ dysfunction Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

BIOLOGICALCAR-NK cell

Chimeric Antigen Receptor Natural Killer Cell


Locations(1)

Tongji Hospital of Tongji University

Shanghai, Shanghai Municipality, China

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT06967038


Related Trials