A Clinical Study of CAR NK Cells for the Treatment of Relapsed/Refractory B-cell Related Autoimmune Diseases

August 12, 2026 updated by: YANRU WANG

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

15

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Jiangsu
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Affiliated Hospital of Jiangsu University
        • Contact:
        • Principal Investigator:
          • Yu Tang, Dr.
      • Zhenjiang, Jiangsu, China, 212001
        • Recruiting
        • Jiangsu University Affiliated Hospital
        • Contact:
        • Principal Investigator:
          • Yu Tang, Doctor

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. 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
  2. Subjects disease status of enrolment: not complete response (CR) after standard treatment; moderately to severely active autoimmune diseases
  3. Age: ≥ 18 years old and ≤ 70 years old, male or female
  4. Subjects with estimated survival > 12 weeks
  5. 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)
  6. ECOG performance ≤ 2
  7. Left ventricular ejection fraction (LVEF) ≥ 45%
  8. Subjects have been treated with OCS in combination with an immunosuppressive or biologic agent for at least 2 weeks prior to enrollment

Exclusion Criteria:

  1. 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
  2. Subjects with one of the following genetic syndromes: Fanconi syndrome, Kostmann syndrome, Shwachman syndrome or any of the known bone marrow failure syndromes
  3. Subjects with active or uncontrolled infections requiring parenteral antimicrobials; evidence of severe active viral or bacterial infections or uncontrolled systemic fungal infections
  4. Subjects with grade III or IV heart failure (NYHA classification)
  5. History of epilepsy or other central nervous system (CNS) diseases
  6. History of other primary malignant tumors except: cured non-melanoma skin cancer or primary cervical cancer; subjects with inactive tumors
  7. Subjects with more pronounced bleeding tendencies, such as gastrointestinal bleeding, coagulation disorders, and hypersplenism
  8. Subjects with unstable angina, symptomatic congestive heart failure or myocardial infarction within the last 6 months
  9. Females who are pregnant, lactating, or planning a pregnancy within six months
  10. Subjects who have received other clinical trial treatment within 3 months
  11. Any situation judged by the investigators that may increase the risk of the subjects or interfere with the clinical trial outcome

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: CAR NK cells
Drug: CAR NK cells
Patients will receive Fludarabine (30mg/m2 per day) and Cyclophosphamide on day -5, -4, and -3, followed by CAR NK cells infusion.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion
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
within 4 weeks after infusion; 12, 24, 36 and 52 weeks after infusion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Disease control rate of subjects
Time Frame: 4, 12, 24, and 52 weeks after infusion
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
4, 12, 24, and 52 weeks after infusion
Remission rate of subjects
Time Frame: 4, 12, 24, and 52 weeks after infusion
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
4, 12, 24, and 52 weeks after infusion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

YANRU WANG

Collaborators

Rui Therapeutics Co., Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 13, 2024

Primary Completion (Estimated)

December 13, 2026

Study Completion (Estimated)

March 13, 2027

Study Registration Dates

First Submitted

March 12, 2024

First Submitted That Met QC Criteria

March 13, 2024

First Posted (Actual)

March 19, 2024

Study Record Updates

Last Update Posted (Actual)

August 13, 2026

Last Update Submitted That Met QC Criteria

August 12, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2023-11-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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