Primary Sjogren's SyndromePhase 1/2CAR-NKNCT06967038
Chimeric Antigen Receptor Natural Killer Cell Therapy for High-risk Lymphoma Patients With Primary Sjogren's Syndrome
A Phase 1/2 study testing CAR-NK cell in people with Primary Sjogren's Syndrome and Lymphoma, run by Bangdong Gong at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary Sjogren's Syndrome, Lymphoma
- What is being tested?
- CAR-NK cell
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 28 Feb 2025to 31 Oct 2027
- Phase
- Phase 1/2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age range of 18-70 years old, gender not limited;
- Diagnosed with primary Sjogren's syndrome, meeting the 2016 ACR/EULAR classification criteria;
- 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;
- 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;
- Normal cognitive function and voluntarily participate in this clinical trial. Signing a written informed consent form. Can follow and complete all trial procedures.
Who cannot join
- Pregnant and lactating women;
- Patients with hepatitis B, hepatitis C, HIV and other virus infections;
- Highly allergic constitution or history of severe allergies;
- Patients with a history of other autoimmune diseases;
- Patients with severe heart failure, respiratory failure, liver dysfunction, kidney failure, persistent bleeding, malignant tumors, and diabetes insipidus;
- There are other situations where the researcher deems it inappropriate to participate in this clinical study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital of Tongji University
Shanghai, Shanghai Municipality, 200065
Bangdong Gong, doctor, 0862166111086, bangdonggong@163.com
Miao Xuan, doctor, 0862166111243
About this study
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
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.
Read the 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
- Being tested
- CAR-NK cell
- Keywords
- primary Sjogren's syndrome, lymphoma, CAR-NK, Dose limiting toxicity
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR-NK cellBiological
Chimeric Antigen Receptor Natural Killer Cell
| Study group | Role | What they receive |
|---|---|---|
| CAR-NK | Experimental | CAR-NK cell therapy Receives: Biological: CAR-NK cell |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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.
Measured: 45 days
Secondary outcomes (4)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 May 2025
- Study start28 Feb 2025
- Primary completion31 Oct 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary Sjogren's SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangdong Gong
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Bangdong Gong, Shanghai Tongji Hospital, Tongji University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06967038
- Sponsor's protocol ID
- Tongji Hospital, Shanghai
- Acronym
- CAR-NK
- Status last verified
- Apr 2025
- First submitted
- 22 Apr 2025
- Last updated
- 13 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06967038
- Acronym / sponsor ID
- CAR-NK / Tongji Hospital, Shanghai
- Conditions
- Primary Sjogren's Syndrome, Lymphoma
- Keywords
- primary Sjogren's syndrome, lymphoma, CAR-NK, Dose limiting toxicity
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Bangdong GongUniversity, hospital or other
- Study start
- 28 Feb 2025 (actual)
- Primary completion
- 31 Oct 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 13 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CAR-NK | Experimental | Biological: CAR-NK cellCAR-NK cell therapy |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Age range of 18-70 years old, gender not limited;
- Diagnosed with primary Sjogren's syndrome, meeting the 2016 ACR/EULAR classification criteria;
- 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;
- 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;
- Normal cognitive function and voluntarily participate in this clinical trial. Signing a written informed consent form. Can follow and complete all trial procedures.
Key exclusion criteria (6 listed)
- Pregnant and lactating women;
- Patients with hepatitis B, hepatitis C, HIV and other virus infections;
- Highly allergic constitution or history of severe allergies;
- Patients with a history of other autoimmune diseases;
- Patients with severe heart failure, respiratory failure, liver dysfunction, kidney failure, persistent bleeding, malignant tumors, and diabetes insipidus;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CAR-NK cellChimeric Antigen Receptor Natural Killer Cell | Biological | CAR-NK |
Primary outcome
Safety: Incidence of Dose limiting toxicity (DLT)
Time frame: 45 days
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).
Safety: Incidence and severity of adverse events (AEs)
Time frame: 45 days
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.
4 secondary outcomes
cell treatment efficacy
Time frame: one year
cell treatment efficacy
Time frame: one year
cell treatment efficacy
Time frame: one year
cell treatment efficacy
Time frame: one year
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 May 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing CAR-NK cell in people with Primary Sjogren's Syndrome and Lymphoma, run by Bangdong Gong at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Safety: Incidence of Dose limiting toxicity (DLT) (time frame: 45 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 May 2025; AzTrials last refreshed its copy on 4 Nov 2026.