NCT06967038

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

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 6 (estimated)
• Sponsor: Bangdong Gong · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

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 weight. Plan to enroll 6-12 subjects. If it is necessary to downregulate the dose due to the safety implications of the initial dose of CAR-NK cells, the researchers will together discuss the level of downregulation or administration method. If the current recommended maximum dose level is not confirmed as a possible recommended therapeutic dose, researchers can decide whether to increase it to a higher dose to determine the possible therapeutic dose. During the experiment, dosage adjustments can be made based on the safety and tolerability data of the subjects. Dose limiting toxicity (DLT) is defined as one or more adverse events related to CAR-NK cell therapy occurring in a subject within 45 days after the first infusion of CAR-NK cells. (1) Inflammatory cytokine release syndrome of grade ≥ 3 within 2 weeks. (2) Allergic reactions of grade 3 or higher within 2 weeks. (3) Organ damage of grade ≥ 3 within 2 weeks (nerve, cardiovascular, lung, genitourinary, gastrointestinal, liver, skin, etc.). (4) Grade ≥ 3 graft-versus-host disease within 45 days. (5) Deaths related to treatment within 45 days.

Conditions

• Primary Sjogren's Syndrome
• Lymphoma

Interventions

Type	Name	Description
BIOLOGICAL	CAR-NK cell	Chimeric Antigen Receptor Natural Killer Cell

Timeline

• Start date: 2025-02-28
• Primary completion: 2027-10-31
• Completion: 2027-10-31
• First posted: 2025-05-13
• Last updated: 2025-05-13

Locations

1 site across 1 country: China