A Study on the Safety and Efficacy of Chimeric Antigen Receptor T Cells in the Treatment of Refractory Myasthenia Gravis

Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1
SUMMARY

This is a single-arm, open-label, single-center, phase I study. The primary objective is to evaluate the safety of CD19 CAR-T therapy for patients with refractory myasthenia gravis, and to evaluate the pharmacokinetics of CD19 CAR-T in patients.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 1\. Age ≥18 and gender unlimited;

• 2\. Confirmed as refractory myasthenia gravis with AchR antibody positive and accord one of the following three conditions

‣ Repeated electrical stimulation suggests neuromuscular conduction deficits;

⁃ Tensilon test and neostigmine test positive;

⁃ The doctor judged that the symptoms of MG improved after treatment with oral cholinease inhibitors;

• 3\. Consistent with the clinical classification of MGFA myasthenia gravis IIa-IVb (including IIa,IIb,IIIa, IIIb, IVa,IVb)

• 4\. The baseline MG-ADL score ≥5 and the musculi oculi related score\< 50 ;

• 5\. Baseline QMG score\>11;

• 6\. Regular treatment with poor efficacy and/or lack of effective treatment means that there is still recurrence or exacerbation after treatment with conventional hormones, immunosuppressants (such as azathioprine, mycophenolate mofetil, tacrolimus, cyclosporine A, cyclophosphamide, etc.) or rituximab;

• 7\. The estimated survival time is more than 12 weeks;

• 8\. Women of childbearing age who have negative urine pregnancy test before medication administration and agree to take effective contraceptive measures during the trial period until the last follow-up.

Locations
Other Locations
China
The first affiliated hospital of medical college of zhejiang university
RECRUITING
Hangzhou
Contact Information
Primary
He Huang, MD
hehuangyu@126.com
13605714822
Backup
Yongxian Hu, MD
huyongxian2000@aliyun.com
+8615957162012
Time Frame
Start Date: 2023-04-30
Estimated Completion Date: 2026-04-20
Participants
Target number of participants: 9
Treatments
Experimental: Treatment Group
Myasthenia Gravis
Related Therapeutic Areas
Sponsors
Leads: Zhejiang University

This content was sourced from clinicaltrials.gov