NEUK203-215 (allogeneic CD19/BCMA CAR‑NK) for adults in China with relapsed or refractory autoimmune diseases

A Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of NEUK203-215 Injection in Adult Chinese Patients With Relapsed/Refractory Autoimmune Diseases

This trial will test whether NEUK203-215, a donor-derived CD19/BCMA-targeted CAR‑NK cell therapy, is safe, tolerable, and may help adults in China whose severe autoimmune diseases have relapsed or not responded to other treatments.

Quick facts

• Phase: EARLY_PHASE1
• Study type: Interventional
• Enrollment: 8 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Neukio Biotherapeutics (Shanghai) Co., Ltd. (industry)
• Locations: 1 site (Shanghai, Shanghai Municipality)
• Trial ID: NCT07144462 on ClinicalTrials.gov

What this trial studies

Adults aged 18–65 with severe, refractory systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis will receive lymphodepleting chemotherapy (fludarabine and cyclophosphamide) followed by infusion of NEUK203-215, an allogeneic CD19/BCMA-targeted CAR‑NK product derived from healthy donors. This early phase 1 interventional protocol focuses on safety, tolerability, and preliminary efficacy signals with close monitoring for infections, organ toxicity, and immune-related adverse events. The trial is conducted at Shanghai Changzheng Hospital and uses strict inclusion and exclusion criteria to limit risk, including exclusions for dialysis dependence, active uncontrolled infection, recent major cardiac events, recent malignancy, significant bleeding, prior organ transplant, or severe drug hypersensitivity. Outcomes will include clinical and laboratory measures tailored to each autoimmune condition, with short-term and exploratory efficacy assessments.

Who should consider this trial

Good fit: Ideal candidates are adults 18–65 in China with confirmed severe, refractory systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis who have adequate organ function and can tolerate lymphodepleting chemotherapy.

Not a fit: Patients who require dialysis, have active uncontrolled infections, recent major cardiac events, recent malignancy, significant bleeding, prior solid-organ transplant, or severe drug hypersensitivity are unlikely to be eligible or to benefit.

Why it matters

Potential benefit: If successful, this could provide a new targeted cell therapy option for people with severe autoimmune diseases that have not responded to standard treatments.

How similar studies have performed: CD19-targeted CAR-T therapies have shown benefit in some refractory autoimmune diseases, but using allogeneic CD19/BCMA CAR‑NK cells for autoimmune conditions is largely novel with limited clinical evidence to date.

Eligibility criteria

Inclusion Criteria:

* 1\) Has provided signed informed consent; 2) Is aged 18-65 years ; 3)Adequate functional reserve of vital organs 4) Has a confirmed diagnosis of systemic lupus erythematosus, diffuse systemic sclerosis, inflammatory myopathy, or autoimmune bullous dermatosis.

Exclusion Criteria:

* 1\) Requires dialysis treatment. 2) History of severe drug hypersensitivity. 3) Active infection requiring systemic therapy or suspected uncontrolled infection.

  4\) Within 6 months before screening, any of the following cardiovascular events: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina, uncontrolled or symptomatic atrial arrhythmia, any ventricular arrhythmia, or other clinically significant cardiac disease.

  5\) Malignancy within the past 5 years. 6) Clinically significant chronic or intermittent bleeding within 60 days before the screening visit.

  7\) Prior solid-organ (e.g., heart, lung, kidney, liver) or hematopoietic stem-cell/bone-marrow transplantation.

  8\) At screening: positive HBsAg and/or HBcAb with HBV DNA detectable or above the lower limit of quantitation; positive HCV antibody with HCV RNA detectable or above the lower limit of quantitation; positive HIV antibody; positive syphilis test (except biologic false-positive results).

  9\) Major surgery within 4 weeks before screening. 10) Live or live-attenuated vaccine received within 4 weeks before screening. 11) Uncontrolled concurrent medical conditions. 12) Documented history of neurologic or psychiatric disorders. 13) Any other factor that, in the investigator's judgment, could require premature withdrawal from the study.

Where this trial is running

Shanghai, Shanghai Municipality

• Shanghai Changzheng Hospital — Shanghai, Shanghai Municipality, China (RECRUITING)

Study contacts

• Study coordinator: Huji Xu

Conditions: Autoimmune