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Tests treatment safety and results for Myasthenia Gravis
Official title A Study to Evaluate the Safety and Preliminary Efficacy of SYS6020 CAR T-cells in Patients With Refractory Generalized Myasthenia Gravis
ClinicalTrials.gov ID: NCT06688435
What this study is testing
What is SYS6020 injection?
SYS6020 injection is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for myasthenia gravis.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is a single-arm, open, 2-stage (dose-escalation phase and dose-expansion phase), multi-center, phase I clinical trial to evaluate the safety and tolerance of SYS6020 injection in the participants with refractory systemic myasthenia gravis, and determine the recommended dose (RD) for subsequent studies of the product, and to preliminarily evaluate the clinical efficacy of the product, as well as to explore the pharmacokinetics and immunogenicity of the product in vivo. The dose-escalation phase and dose-expansion phase include 7 periods, and they are respectively in sequence as follows: the screening period, apheresis period, pre-dosing assessment, SYS6020 injection infusion, DLT observation period, the primary follow-up period (6 months), and the long-term follow-up period (5 years).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- 1) The ages ≥18 and ≤ 65 years old;
- 2)Diagnosed as generalized myasthenia gravis (GMG), the clinical classification of MGFA II-IV；
- 3) Diagnosed as refractory myasthenia gravis (refractory MG) ；
- 4) QMG score \>11 in the screening period and before apheresis;
- 5) Positive acetylcholine receptor antibody (AChR-Ab) and/or muscle-specific receptor tyrosine kinase (MuSK) antibody in the screening period;
You likely can't join if
- 1) Have been known to have allergic reactions, hypersensitivity, intolerance or contraindications to SYS6020（including its active ingredient and...
- 2) Participants with major chronic diseases that are not well-controlled and considered to increase the participant's risk potentially by the...
- 3) Participants with other autoimmune diseases that require systemic treatment. Participants with stable autoimmune thyroid diseases who have a...
- 4) Participants with a severe recurrent infection during the screening period, or any active infection that the investigator considers may affect the...
- 5)Participants with a history of positive HIV; participants with positive HBsAg; participants with positive HBcAb and with HBV-DNA above the...
- 6) Participants with a history of malignant tumors within the past 5 years or with current active malignant tumors. Participants with successfully...
See the full eligibility criteria
- 1) The ages ≥18 and ≤ 65 years old;
- 2)Diagnosed as generalized myasthenia gravis (GMG), the clinical classification of MGFA II-IV；
- 3) Diagnosed as refractory myasthenia gravis (refractory MG) ；
- 4) QMG score \>11 in the screening period and before apheresis;
- 5) Positive acetylcholine receptor antibody (AChR-Ab) and/or muscle-specific receptor tyrosine kinase (MuSK) antibody in the screening period;
- 6) The daily dose of concomitant glucocorticoid therapy must not exceed 40mg prednisone or equivalent dose and the dose have to be stable for ≥4 weeks prior to baseline.
- 7) Participants have a thorough understanding of this clinical trial and voluntarily sign a written informed consent form.
- 1) Have been known to have allergic reactions, hypersensitivity, intolerance or contraindications to SYS6020（including its active ingredient and excipient dextran 40） or the drugs potentially used in the study, or who...
- 2) Participants with major chronic diseases that are not well-controlled and considered to increase the participant's risk potentially by the investigator;
- 3) Participants with other autoimmune diseases that require systemic treatment. Participants with stable autoimmune thyroid diseases who have a normal thyroid function and are at a stable therapeutic dose are allowed to...
- 4) Participants with a severe recurrent infection during the screening period, or any active infection that the investigator considers may affect the patient's participation;
- 5)Participants with a history of positive HIV; participants with positive HBsAg; participants with positive HBcAb and with HBV-DNA above the measurable limit;
- 6) Participants with a history of malignant tumors within the past 5 years or with current active malignant tumors. Participants with successfully treated localized tumors, as well as those with thymomas classified as...
- 7) Any serious respiratory system disease.
- 8) Participants with a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities.
- 9) Abnormal laboratory findings with clinical significance, including ALT, AST\>3\ ULN； Scr\>1.5\ ULN； INR\>1.5\ ULN, and so on. .
- 10) Individuals with potential disease conditions (including laboratory abnormalities) which are considered of clinical significance by the investigator; individuals with alcohol dependence or drug abuse .
- 11) Individuals with a current psychotic disorder that interferes with adherence.
- 12) Participants with a history of primary immunodeficiency disease, organ or hematopoietic stem cell/bone marrow transplantations before screening; or those planning to undergo a transplantation during the trial;
- 13) Participants with a history of ≥ Grade 2 (CTCAE 5.0 standard) bleeding within 30 days before screening, or those requiring long-term continuous treatments with anticoagulant drugs.
- 14) Participants who have received any CAR-T therapy or gene therapy before.
- 15) Participants who have received intravenous injection of human immunoglobulin (IVIG) or plasmapheresis (PE), plasma separation, or hemodialysis within 1 month before apheresis.
- 16) Participants who have used calcineurin inhibitors, or cyclophosphamide or neonatal Fc receptor antagonists within 3 weeks before apheresis and 8 weeks before the first dosing. Participants who have used targeted...
- 17) Any situations that the investigator believes that the participant is not suitable for this clinical trial for any other reasons.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.