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Résztvevőt keres itt: Kína1. fázis

A Study to Evaluate the Safety and Preliminary Efficacy of SYS6020 CAR T-cells in Patients With Refractory Generalized Myasthenia Gravis

A legfontosabb adatok

Ki végzi
CSPC ZhongQi Pharmaceutical Technology Co., Ltd.
Hol
Jinan (Kína)A helyszín megnézése
Azonosító
Állapot
Toboroz
Fázis
1. fázis
Résztvevők
60 fő, tervezett
Kezdés
2025. márc. 4.
Várható befejezés
2033. máj. 1.
A vizsgálat típusa
Beavatkozással járó, 7 csoport
A vizsgált kezelések
  • SYS6020 injection
A regiszteradat frissítve
2026. augusztus 12.

Ki vehet részt

MI-összefoglaló

A vizsgálat saját részvételi feltételeiből. Gép olvasta ki az oldalon álló regiszterszövegből, ezért tévedhet. Hogy ki vehet részt, azt a lenti regiszterszöveg és a vizsgálat csapata dönti el.

A vizsgálat olyan felnőtteket keres, akiknek generalizált myasthenia gravisa a szokásos kezelésre nem reagált. SYS6020 CAR T-sejt kezelést kapnak.

Életkor
18 és 70 év között a bevonási feltételek szerint (a nyilvántartás fejléce legfeljebb 65 évet említ).
Nem
Mindkét nemű jelentkező részt vehet.
A betegség stádiuma
Generalizált myasthenia gravis, MGFA II-IVa osztály, a szokásos kezelésre nem reagáló, a QMG pontszám a szűréskor és az aferézis előtt 11 fölött van.
Korábbi kezelés
A napi glükokortikoid adag az aferézis előtti 7 napban legfeljebb 20mg prednizon vagy azzal egyenértékű lehet. Korábban nem kaphatott CAR-T- vagy génterápiát. Az aferézis előtti 1 hónapban nem kaphatott IVIG-t, plazmaferézist vagy hemodialízist. Az aferézis előtti 3 hónapban nem kaphatott rituximabhoz hasonló B-sejt elleni szert.
Biomarker vagy leletérték
Pozitív acetilkolin-receptor ellenanyag (AChR-Ab) és/vagy MuSK ellenanyag a szűréskor.

A részvétel fő kizáró okai

  • Allergia a SYS6020-ra vagy összetevőire, köztük a dextran 40-re
  • Más, szisztémás kezelést igénylő autoimmun betegség
  • HIV a kórelőzményben, pozitív HBsAg, vagy pozitív HBV-DNS vagy HCV-RNS
  • Rosszindulatú daganat az elmúlt 5 évben vagy jelenleg (egyes kezelt esetek kivételek)
  • Korábbi szervátültetés vagy őssejt-/csontvelő-átültetés

A regiszter feltételei, szó szerint

Mind a 24 feltétel megnézéseKevesebb

Ki vehet részt

  • 1) The ages ≥18 and ≤ 70 years old
  • 2) Diagnosed as generalized myasthenia gravis (GMG), the clinical classification of MGFA II-IVa
  • 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 20mg prednisone or equivalent within 7 days prior to apheresis
  • 7) Participants have a thorough understanding of this clinical trial and voluntarily sign a written informed consent form

Ki nem vehet részt

  • 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 have had a previous history of severe allergic reactions
  • 5)Participants with a history of positive HIV; participants with positive HBsAg; participants with positive HBcAb and with HBV-DNA above the measurable limit;(Note: participants with positive HBV-DNA or HCV-RNA results within 6 months prior to ICF are excluded)
  • 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. Participants who have used targeted B-cell biological agents such as rituximab within 3 months before apheresis. Participants who started receiving eculizumab treatment within 8 weeks before the first dosing；
  • 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 be enrolled
  • 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
  • 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 participants with WHO histological type A, AB, B1 or B2thymoma, with no evidence of recurrence or metastasis for at least 1 year after complete resection assessed by the investigator , are allowed to be enrolled;)
  • 7) Any serious respiratory system disease
  • 8) Participants with a history of serious cardiovascular disease, such as severe cardiac rhythm or conduction abnormalities
  • 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
  • 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
  • 17) Any situations that the investigator believes that the participant is not suitable for this clinical trial for any other reasons

Nézd meg, megfelelhetsz-e

Magadról válaszolj. Ez nem döntés: hogy részt vehetsz-e, azt csak a vizsgálat csapata mondhatja meg.

  • 18 és 65 év között vagy?

Helyszínek itt: Kína

  • Qilu Hospital，Shandong UniversityJinan, KínaContact: Chuanzhu YanRésztvevőt keres

A vizsgálatról

Mit akar kideríteni a vizsgálat

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.

A teljes eredeti leírásKevesebb

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). The DLT observation period is 28 days after receiving SYS6020 injection. The participants will not undergo lymphodepleting chemotherapy.

The efficacy and safety profile of the participants will be continuously assessed during the trial. Efficacy measurement includes the MG-ADL, QMG, MGC, MG-QoL 15R scale, MGFA clinical classification, and MGFA post-intervention state (MGFA PIS) grading scales, as well as self-antibodies, etc. Safety measurement includes vital signs, physical examination, laboratory tests, cytokines, and ECG, etc. The adverse events and concomitant therapy will be continuously collected during the trial. In addition, during the study period, blood samples will be collected from participants who have received SYS6020 treatment for PK/PD test, and immunogenicity test.

For the dose-escalation phase, 3 to 5 dose levels are proposed to be explored. The Safety Monitoring Committee (SMC) will discuss the safety data and make a decision if the next SYS6020 injection could be initiated or dose-escalation could be initiated. After the completion of the dose-escalation phase, the recommended doses would be determined for dose-expansion phase. For the dose-expansion phase, further safety and efficacy data will be collected among the participants who will receive the recommended dose of SYS6020 injection.

A vizsgálat 7 csoportja

  • SYS6020 injection: 2*106CAR+ T-cells per kg(dose level 1)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed. Participants will receive 3 doses treatment of SYS6020 injection, with a dose level of 2\*106CAR+ T-cells per kg. If one DLT occurs in three participants, additional 3 ones may be considered to be enrolled after SMC safety data review and make a determination.

    Kezelés: SYS6020 injection

  • SYS6020 injection: 6*106CAR+ T-cells per kg(dose level 2)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed. Participants will receive 3 doses treatment of SYS6020 injection, with a dose level of 6\*106CAR+ T-cells per kg. If one DLT occurs in three participants, additional 3 ones may be considered to be enrolled after SMC safety data review and make a determination.

    Kezelés: SYS6020 injection

  • SYS6020 injection: 1.8*107CAR+ T-cells per kg(dose level 3)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed. Participants receive 3 doses of SYS6020 injection, with a dose level of 1.8\*107CAR+ T-cells per kg. If one DLT occurs in three participants, additional 3 ones may be considered to be enrolled after SMC safety data review and make a determination.

    Kezelés: SYS6020 injection

  • SYS6020 injection: 3.6*107CAR+ T-cells per kg(dose level 4)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed. Participants receive 3 doses of SYS6020 injection, with a dose level of 3.6\*107CAR+ T-cells per kg. If one DLT occurs in three participants, additional 3 ones may be considered to be enrolled after SMC safety data review and make a determination.

    Kezelés: SYS6020 injection

  • SYS6020 injection: 5.4*107CAR+ T-cells per kg(dose level 5)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed. Participants receive 3 doses of SYS6020 injection, with a dose level of 5.4\*107CAR+ T-cells per kg. If one DLT occurs in three participants, additional 3 ones may be considered to be enrolled after SMC safety data review and make a determination.

    Kezelés: SYS6020 injection

  • SYS6020 injection (Expansion stage group A)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed.

    Kezelés: SYS6020 injection

  • SYS6020 injection (Expansion stage group B)A vizsgált kezelés

    Participants will undergo leukapheresis to isolate peripheral blood mononuclear cells to manufacture SYS6020 injection, during which no lymphodepleting chemotherapy will be performed.

    Kezelés: SYS6020 injection

Kérdések a vizsgálat csapatának

  1. Milyen gyakran kell bejárnom, és egy-egy alkalom mennyi ideig tart?
  2. Megtérítik az utazási költséget?
  3. Megtarthatom a saját orvosomat?
  4. Mi történik, ha ki akarok lépni?

Contact the study team: see the registry record → Contacts and Locations

Oldal nyomtatása az orvosomnak

Adatok és források

Regiszteradat
Szerepel a ClinicalTrials.gov-on.
Hivatalos cím
A Phase I Study to Evaluate BCMA-targeted Chimeric Antigen Receptor T Cell (SYS6020 Injection) in Patients With Refractory Generalized Myasthenia Gravis
MI-összefoglaló
A vizsgálat saját részvételi feltételeiből. Gépi kiolvasás: 2026. november 12.
Illeszkedési kérdések
Forrás: NCT06688435: ki vehet részt
A regiszteradat frissítve
2026. augusztus 12.