Loading clinical trials...

Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis | Clinical Trials | Clareo Health

NOT_YET_RECRUITINGEARLY_PHASE1

Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis

Exploratory Clinical Trial of Allogeneic CD19-CAR-NK Cells in Patients With Refractory Myasthenia Gravis

NCT07243366•Guangdong ProCapZoom Biosciences Co., Ltd.

View on ClinicalTrials.gov

Summary

This study is a single-center, prospective, nonrandom, single-arm trial.

Detailed Description

This study is a single-center, prospective, nonrandom, single-arm trial. To evaluate the clinical safety and efficacy of allogeneic CD19-CAR-NK Cells in patients with refractory myasthenia gravis.

Eligibility

Age

18 - 65 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•Aged 18-65 years old, including the boundary value, no gender restriction;
•MGFA clinical class II-IV;
•Anti-acetylcholine-receptor antibody (AChR-Ab) shows positive;
•Willing to participate in the study, understand and sign the informed consent form (ICF).
•Baseline characteristics - all must be fulfilled:
•1. Refractory MG patients: Meet the diagnostic criteria in the Chinese Guidelines for the Diagnosis and Treatment of MG (2020 edition). On the basis of typical MG clinical features (fluctuating muscle weakness), a diagnosis can be made if any of the following three points are met, including pharmacological examination, electrophysiological characteristics, and serum anti-AChR antibody testing. Other diseases must also be excluded.
•2. Myasthenia Gravis Activities of Daily Living (MG-ADL) score ≥ 6, with ocular sub-score \< 50 % of total.
•Diagnostic Criteria: Meeting any one of the following four conditions:
•1. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants), and at least one complete treatment cycle with a biologic agent (efgartigimod, eculizumab, rituximab, or telitacicept), the post-intervention status (PIS) remains unchanged or worsens.
•2. Following an adequate dose and full course of at least two conventional immunotherapies (including both corticosteroids and non-steroidal immunosuppressants) and at least one complete treatment cycle with a biologic agent, the PIS improves, yet the MG-ADL score is still ≥6 and persists for at least six months.
+4 more criteria

Exclusion Criteria

•Received IVMP, IVIG, or TPE within the 2 months before the current visit;
•Unable to cooperate in completing the MG-ADL, or QMG, or Quantitative QMG questionnaire.
•Judged by a senior clinician to have any of the following: 1)Severe or chronic urinary-tract infection; 2)History of recurrent infections; 3)Previous allergy to any human-derived biologic drug; 4)Depression, suicidal ideation, or other psychiatric disorder;
•Patients with active infection, such as herpes zoster, HIV, active tuberculosis, or active hepatitis.
•Rituximab within 6 months, eculizumab within 3 months, or efgartigimod within 1 month before enrollment.
•Receipt of any live vaccine within 3 months before screening or planned vaccination during the study.
•Subjects deemed unsuitable for participation in this trial by the investigator (e.g., severe psychiatric illness).

Key Dates

Start Date

November 25, 2025

Primary Completion Date

June 30, 2027

Completion Date

November 30, 2027

Last Updated

November 21, 2025

Enrollment

ESTIMATED participants

Conditions

Refractory Myasthenia Gravis

Interventions

CD19-CAR-NK Cells Injection

DRUG

Contacts

Jiexing Chen

CONTACT

183 0200 2029 jxchen@procapzoom.com

A Pilot Trial of Rituxan in Refractory Myasthenia Gravis

NCT00619671

Refractory Myasthenia Gravis

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: November 21, 2025Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

View ClinicalTrials.gov Terms and Conditions