A Phase 1/2 interventional study of CAR-NK cell in Primary Sjogren's Syndrome and Lymphoma, sponsored by Bangdong Gong. Recruiting at 1 site in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2025-05-13.
Sponsored by Bangdong Gong · Phase 1/2, Interventional, and Treatment
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.
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.
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This study's planned enrollment of 6 is below the median of 40 across 4,534 interventional studies indexed under Lymphoma.
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Exclusion Criteria:
CAR-NK cell therapy
Biological: CAR-NK cell
Chimeric Antigen Receptor Natural Killer Cell
Safety: Incidence of Dose limiting toxicity (DLT)
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. Researchers can together 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, including limiting toxicity type, incidence, and severity of dose limiting toxicity (DLT).
Time frame: 45 days
Safety: Incidence and severity of adverse events (AEs)
One or more adverse events are 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.
Time frame: 45 days
cell treatment efficacy
A change in the high-risk of lymphoma in pSS patients. Physical examination or B-ultrasound or CT scan indicates change in salivary gland, lymph node, liver, and spleen enlargement.
Time frame: one year
cell treatment efficacy
At least partial relief of dry mouth and eye symptoms. Two out of three (dryness, pain, and fatigue) visual analog scales (from 0 \[best\] to 10 \[worst\]) showed a decrease of 30% or more in scores.
Time frame: one year
cell treatment efficacy
(1) Improved saliva flow rate. The normal range for static saliva flow rate is 0.3-0.4 milliliters per minute, while the normal range for stimulated saliva flow rate (such as after chewing stimulation) is 1.5-2.0 milliliters per 5 minutes. (2) Improved emission computer tomography of salivary gland, including bilateral parotid and submandibular gland uptake and excretion function (relative percentage). (3) Improved schirmer experiment. Normally greater than 5 millimeters per minute. (4) Improved corneal fluorescence staining. Abnormal manifestations include punctate coloring, patchy or linear coloring, or diffuse coloring.
Time frame: one year
cell treatment efficacy
Improvement of Disease Activity Scale. Scoring criteria is EULAR Sjögren's Syndrome Disease Activity Index (ESSDAI). Based on the degree and severity of the lesion, the total score is 51 points, with higher scores indicating more active disease.
Time frame: one year
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