Autoimmune DiseasesEarly Phase 1NCT06318533
A Clinical Study of CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
A Early Phase 1 study testing CAR NK cells in people with Autoimmune Diseases, run by YANRU WANG at 2 sites in China.
Trial summary
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial . Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- CAR NK cells
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 2 sitesChina
- Study dates
- 13 Mar 2024to 13 Mar 2027
- Phase
- Early Phase 1
- 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
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
- Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
- Age: ≥ 18 years old and ≤ 70 years old, male or female
- Subjects with estimated survival > 12 weeks
- Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
- ECOG performance ≤ 2
- Left ventricular ejection fraction (LVEF) ≥ 45%
- Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment
Who cannot join
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions
- Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
- Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
- Subjects with grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system (CNS) diseases
- History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
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- Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
- Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
- Females who are pregnant, lactating, or planning a pregnancy within six months
- Subjects who have received other clinical trial treatment within 3 months
- Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
Affiliated Hospital of Jiangsu University
Zhenjiang, Jiangsu, 212001
Yu Tang, 086-13815153350, tangtang@ujs.edu
Yu Tang, Dr.
- Recruiting
Jiangsu University Affiliated Hospital
Zhenjiang, Jiangsu, 212001
Yanru Wang, 0511-85026079, tangtang@ujs.edu
Yu Tang, Doctor
About this study
Official title: An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injections for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial . The primary objective of the study is to evaluation of the safety and feasibility of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete B cells of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.
- Conditions
- Autoimmune Diseases
- Being tested
- CAR NK cells
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CAR NK cellsDrug
Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.
| Study group | Role | What they receive |
|---|---|---|
| CAR NK cells | Experimental | Not described Receives: Drug: CAR NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose Limiting Toxicity (DLTs)
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases.
Measured: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
Treatment Emergent Adverse Events（TEAEs）
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases
Measured: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
Secondary outcomes (2)
Disease control rate of subjects
To characterize the efficacy of CAR NK Cells for moderate to severe autoimmune diseases. Disease control is assessed according to SLEDAl 2K. Disease control rate is defined as proportion of patients with SRI-4 response: including SLEDAI 2K ≥ 4-Point improvement
Measured: 4, 12, 24, and 52 weeks after infusion
Remission rate of subjects
To characterize the efficacy of CAR NK Cells for moderate to severe autoimmune diseases. Remission is assessed according to SLEDAl 2K. Remission rate is defined as proportion of patients with SLEDAl 2K score= 0
Measured: 4, 12, 24, and 52 weeks after infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2024
- Study start13 Mar 2024
- Primary completion13 Dec 2026 (estimated)
- Study completion13 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- YANRU WANG
- Sponsor type
- University, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Responsible party
- Sponsor-investigator, YANRU WANG, Affiliated Hospital of Jiangsu University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06318533
- Sponsor's protocol ID
- 2023-11-01
- Status last verified
- Aug 2026
- First submitted
- 12 Mar 2024
- Last updated
- 13 Aug 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Exploratory Clinical Study of the Safety and Efficacy of Chimeric Antigen Receptor NK Cell Injections for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT06318533
- Acronym / sponsor ID
- 2023-11-01
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- YANRU WANGUniversity, hospital or other
- Collaborators
- Rui Therapeutics Co., Ltd
- Study start
- 13 Mar 2024 (actual)
- Primary completion
- 13 Dec 2026 (estimated)
- Study completion
- 13 Mar 2027 (estimated)
- First posted
- 19 Mar 2024 (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.
A single arm, open-label pilot study is designed to determine the safety and effectiveness of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.15 patients are planned to be enrolled in the dose-escalation trial . The primary objective of the study is to evaluation of the safety and feasibility of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The secondary objective is to evaluate the effectiveness of CAR NK cells for the treatment of relapsed/refractory B-cell related autoimmune diseases. The exploratory objective is to evaluate expansion, persistence and ability to deplete B cells of CAR NK cells in patients with relapsed/refractory B-cell related autoimmune diseases.
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 cells | Experimental | Drug: CAR NK cells |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Subjects voluntarily participate in this clinical study and sign the Informed Consent Form (ICF) and are willing to follow and be able to complete all trial procedures
- Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
- Age: ≥ 18 years old and ≤ 70 years old, male or female
- Subjects with estimated survival > 12 weeks
- Adequate organs function: Serum creatinine clearance meets relevant age/sex criteria,aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 3 times the upper limit of normal (ULN)
Key exclusion criteria (11 listed)
- Subjects with known severe allergic reactions, hypersensitivity, contraindication to any medications during the trial (cyclophosphamide, fludarabine, tozumabs), or subjects with a history of severe allergic reactions
- Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
- Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
- Subjects with grade III or IV heart failure (NYHA classification)
- History of epilepsy or other central nervous system (CNS) diseases
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 cellsPatients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion. | Drug | CAR NK cells |
Primary outcome
Incidence of Dose Limiting Toxicity (DLTs)
Time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases.
Treatment Emergent Adverse Events（TEAEs）
Time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
To characterize the safety of CAR NK Cells for moderate to severe autoimmune diseases
2 secondary outcomes
Disease control rate of subjects
Time frame: 4, 12, 24, and 52 weeks after infusion
Remission rate of subjects
Time frame: 4, 12, 24, and 52 weeks after infusion
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 Aug 2026.
- Individual participant dataSharing planned: No
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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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CAR NK cells in people with Autoimmune Diseases, run by YANRU WANG at 2 sites 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 8 inclusion and 11 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 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Incidence of Dose Limiting Toxicity (DLTs) (time frame: within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion). 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 Aug 2026.