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

Trial statusNot yet recruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGuangdong ProCapZoom Biosciences Co., Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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).

Disqualifiers

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.

Trial design

Design model

Single group

Treatments tested in this trial

  • CD19-CAR-NK Cells Injection

    Drug

    Allogeneic CD19-CAR-NK cells will be administered intravenously at a fixed dose, once every two weeks for a total treatment duration of 24 weeks.

Treatment groups

15 Participants
are divided into 1 treatment group
Group A: CD19-CAR-NK Cells GroupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Adverse Events

Incidence and severity of adverse events from subjects during the trial.

Time frame
through study completion, an average of 1 year

Secondary outcomes

1

Myasthenia Gravis Activities of Daily Living Scores

Changes in myasthenia gravis activities of daily living scores from baseline at every 2-week on-treatment visit and each follow-up, including mean change and symptom fluctuation.

Time frame
at every 2-week on-treatment visit (up to 1 month) and each follow-up (up to 1 year)
2

Quantitative Myasthenia Gravis Scores

Changes in quantitative myasthenia gravis scores from baseline at every 2-week on-treatment visit and each follow-up, including mean change and symptom fluctuation.

Time frame
at every 2-week on-treatment visit (up to 1 month) and each follow-up (up to 1 year)
3

Myasthenia Gravis Foundation of America Post-intervention Status

Changes in myasthenia gravis foundation of America post-intervention status from baseline at every 2-week on-treatment visit and each follow-up.

Time frame
at every 2-week on-treatment visit (up to 1 month) and each follow-up (up to 1 year)
4

AChR-antibody titers

Changes in AChR-antibody titers from baseline at every 2-week on-treatment visit and each follow-up.

Time frame
at every 2-week on-treatment visit (up to 1 month) and each follow-up (up to 1 year)

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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