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Multiple SclerosisPhase 1/2NCT07756268

Phase Ib/II Study of SYS6020 in Relapsing/Refractory Multiple Sclerosis

A Phase 1/2 study testing SYS6020 injection in people with Multiple Sclerosis, run by Tongji Hospital at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This trial is an investigator-initiated, single-arm, open-label Phase Ib/II study to observe the safety, tolerability, PK/PD characteristics, immunogenicity, and the efficacy of SYS6020 injection in participants with relapsed/refractory multiple sclerosis. Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Multiple Sclerosis
What is being tested?
SYS6020 injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
25 participants
Where
1 siteChina
Study dates
16 Sep 2026to 7 Feb 2029
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. Male or female participants aged 18-65 years at the time of signing informed consent.
  • 2. Diagnosis of progressive multiple sclerosis (primary progressive MS [PPMS] or secondary progressive MS [SPMS]) or relapsing multiple sclerosis (RMS) according to the 2024 McDonald criteria.
  • 3. Inadequate response to at least one disease-modifying therapy (DMT) administered for ≥6 months:
  • For progressive MS: evidence of worsening disability, such as an increased Expanded Disability Status Scale (EDSS) score.
  • For RMS: at least one of the following:
  • ≥2 relapses within 2 years before screening; ii. ≥1 relapse within 1 year before screening; or iii. Gadolinium-enhancing lesions on MRI within 1 year before screening. 4. Positive cerebrospinal fluid oligoclonal bands or an elevated immunoglobulin G index, documented previously or during screening.
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  • 5. Typical MS lesions on brain and/or spinal cord MRI, documented previously or during screening.
  • 6. Screening EDSS score of 3.0-7.0. 7. Adequate baseline organ function, including:
  • Absolute lymphocyte count ≥0.3 × 10⁹/L, absolute neutrophil count ≥1.0 × 10⁹/L, platelet count ≥50 × 10⁹/L, and hemoglobin ≥80 g/L, without red blood cell or platelet transfusion or colony-stimulating factor within 7 days before testing;
  • Total bilirubin ≤2 × upper limit of normal (ULN), and alanine aminotransferase and aspartate aminotransferase ≤3 × ULN;
  • Serum creatinine ≤1.5 × ULN and creatinine clearance ≥40 mL/min by the Cockcroft-Gault formula;
  • Activated partial thromboplastin time and international normalized ratio ≤1.5 × ULN;
  • Oxygen saturation ≥90% on room air;
  • Serum potassium ≥3.0 mmol/L and calcium ≥2.0 mmol/L. 8. Participants of reproductive potential must use reliable contraception during the study and for at least 2 years after the last SYS6020 infusion. Women must not donate oocytes and men must not donate sperm for assisted reproduction during this period. Women of childbearing potential must have a negative serum pregnancy test at screening and a negative serum or urine pregnancy test before leukapheresis.

Who cannot join

  • 1. Uncontrolled significant chronic disease that, in the investigator's opinion, may increase the participant's risk.
  • 2. Another autoimmune disease requiring systemic treatment, except adequately treated autoimmune thyroid disease with stable treatment and normal thyroid function.
  • 3. History of primary immunodeficiency, organ transplantation, or hematopoietic stem cell/bone marrow transplantation, or planned transplantation during the study.
  • 4. Current psychotic disorder. 5. Suicidal ideation within 6 months before informed consent, suicidal behavior within 12 months before informed consent, or a significant suicide risk in the investigator's opinion.
  • 6. Alcohol or drug abuse/dependence likely to impair study compliance. 7. Stroke, transient ischemic attack, or another active central nervous system disorder unrelated to neuroimmunological disease within 6 months before enrollment.
  • 8. Significant cardiovascular disease, including:
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  • Clinically significant ventricular arrhythmia, second- or third-degree atrioventricular block, or another serious rhythm/conduction disorder;
  • Resting QT interval corrected using Fridericia's formula >450 msec for men or >470 msec for women;
  • Acute coronary syndrome, congestive heart failure, or another Grade ≥3 cardiovascular event within 6 months before first administration;
  • Left ventricular ejection fraction <50%;
  • Risk factors for QT prolongation or arrhythmia, including heart failure, hypokalemia, congenital long QT syndrome, family history of long QT syndrome, or use of QT-prolonging medications;
  • Poorly controlled hypertension, defined as systolic blood pressure ≥160 mmHg and/or diastolic blood pressure ≥100 mmHg.
  • 9. Major surgery or invasive intervention within 4 weeks before leukapheresis, or planned systemic or local tumor resection during the study.
  • 10. Grade ≥2 bleeding within 30 days before screening or a need for continuous long-term anticoagulant therapy.
  • 11. Active malignancy or history of malignancy, except:
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  • Curatively treated basal cell carcinoma, localized cutaneous squamous cell carcinoma, or cervical carcinoma in situ completed >12 months before screening; or
  • Other malignancies with curative treatment completed ≥5 years before screening. 12. Severe recurrent infections or any active infection that may interfere with study participation.
  • 13. Any of the following viral hepatitis findings:
  • <!-- -->
  • Positive hepatitis B surface antigen;
  • Positive hepatitis B core antibody with hepatitis B virus DNA above the lower limit of quantification or 1000 copies/mL (500 IU/mL), whichever is lower;
  • Positive hepatitis C virus antibody with hepatitis C virus RNA above the lower limit of quantification or 1000 copies/mL, whichever is lower.
  • (Participants with detectable hepatitis B virus DNA or hepatitis C virus RNA within 6 months before screening who subsequently became undetectable after antiviral treatment are also excluded.) 14. History of human immunodeficiency virus infection or positive HIV test at screening.
  • 15. Inability or unwillingness to receive investigator-required prophylaxis against Pneumocystis jirovecii, herpes simplex virus, or herpes zoster; or a positive confirmatory syphilis test.
  • 16. Positive human T-cell lymphotropic virus type 1/2 antibody, cytomegalovirus immunoglobulin M, or Epstein-Barr virus immunoglobulin M.
  • 17. Active bacterial, fungal, or viral infection requiring intravenous antimicrobial therapy within 2 weeks before leukapheresis, or another infection considered clinically relevant by the investigator. Prophylactic antimicrobial treatment without clinical evidence of active infection is permitted.
  • 18. Receipt of a live vaccine within 4 weeks before leukapheresis or planned live vaccination during the study. Messenger RNA vaccines are not considered live vaccines.
  • 19. Previous or active tuberculosis infection or a positive T-SPOT test. 20. Previous CAR-T-cell therapy other than SYS6020 or previous gene therapy. 21. Renal replacement therapy within 3 months before screening or anticipated need for renal replacement therapy during the study.
  • 22. Intravenous immunoglobulin, plasma exchange, plasmapheresis, or hemodialysis within 1 month before leukapheresis.
  • 23. Prednisone ≥20 mg/day, or equivalent corticosteroid dose, within 7 days before leukapheresis.
  • 24. Calcineurin inhibitors, such as tacrolimus or cyclosporine, or cyclophosphamide within 3 weeks before leukapheresis.
  • 25. Receipt of an investigational product within 4 weeks before screening, unless at least 5 half-lives have passed since last dose, or concurrent participation in another interventional clinical study. Observational studies and follow-up periods of completed interventional studies are permitted.
  • 26. Known allergy, hypersensitivity, intolerance, or contraindication to SYS6020 or its components, including dextran 40; to study-related medications such as acetaminophen or tocilizumab; to beta-lactam antibiotics; or a history of severe allergic reactions.
  • 27. Other drug allergies suggesting an allergic predisposition in the investigator's opinion, or a positive dextran 40 skin test at screening.
  • 28. Any other condition that, in the investigator's opinion, makes the participant unsuitable for the study.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Yuhang Cheng contact

+86-13125197960

chengyh_tj@163.com

China1 site

  • Tongji Hospital, Tongji Medical College of Hust

    Wuhan, Hubei, 430000

    Yuhang Cheng, +86-13125197960, chengyh_tj@163.com

    Daishi Tian, MD

Other trials in China

About this study

Official title: A Phase Ib/II Clinical Study to Evaluate the Safety and Efficacy of SYS6020 Injection in Patients With Relapsing/Refractory Multiple Sclerosis

This trial is an investigator-initiated, single-arm, open-label Phase Ib/II study to observe the safety, tolerability, PK/PD characteristics, immunogenicity, and the efficacy of SYS6020 injection in participants with relapsed/refractory multiple sclerosis. The study plans to enroll participants with progressive or relapsing multiple sclerosis.

The recommended dosing regimen is as follows: a single administration dose of 45×10^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses.

Read more

To ensure participant safety, this study will establish a Safety Monitoring Committee (SMC). A staggered enrollment and dosing strategy will be adopted in the early stage. Two early safety evaluation will be established (after the first 3 enrolled participants complete their first 3 infusions of SYS6020, and after the first 3 enrolled participants complete their first 6 infusions of SYS6020) for comprehensive assessment.

The study plans to enroll 10-15 participants. Once the enrollment of 10-15 participants is complete, a comprehensive assessment may be conducted based on the actual progress of the study and combined with existing data. This will fully evaluate the safety, preliminary efficacy, and PK/PD/ADA data of the enrolled participants. If the overall safety of the participants is manageable, preliminary efficacy shows a positive trend, and there are value and necessity for further exploration, expanding the number of participants may be considered (up to a maximum of 25 participants in total).

Being tested
SYS6020 injection
Keywords
SYS6020, BCMA, Autologous CAR-T Cell Therapy, mRNA CAR-T, Multiple Sclerosis, Primary Progressive Multiple Sclerosis, Secondary Progressive Multiple Sclerosis
Medical subject headings
Multiple Sclerosis, Multiple Sclerosis, Chronic Progressive

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SYS6020 injectionBiological

    SYS6020 injection is an injection of autologous CAR-T cells that have been temporarily transfected with LNP-mRNA targeting BCMA. The eligible participants will receive a single administration dose of 45×10^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses

Study groups in NCT07756268
Study groupRoleWhat they receive
SYS6020 injectionExperimentalUse this field to provide additional information about the arm, including a description of the intervention(s) administered. Participants will receive a single administration dose of 45×10^6 CAR-T cells/kg (allowing a fluctuation of ±20%), administered once a week for 6 consecutive doses
Receives: Biological: SYS6020 injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Safety and tolerability

    Incidence, severity, and relationship of adverse events and serious adverse events, and incidence of clinically significant laboratory abnormalities.

    Measured: From informed consent through Month 24

Secondary outcomes (23)

  1. Time to 12-Week Confirmed Disability Progression (CDP) in Participants with Progressive Multiple Sclerosis

    Time to protocol-defined worsening in Expanded Disability Status Scale (EDSS) score sustained for at least 12 weeks in participants with SPMS or PPMS

    Measured: Month 24

  2. Annualized Relapse Rate (ARR) in Participants with Relapsing Multiple Sclerosis

    Number of protocol-defined relapses divided by total participant-years of follow-up

    Measured: Time Frame: Month 24

  3. Change from Baseline in EDSS(Expanded Disability Status Scale) Score

    The EDSS ranges from 0 to 10, with higher scores indicating greater neurological disability.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  4. Proportion of Participants with an Improvement of at Least 1.0 Point in EDSS(Expanded Disability Status Scale) Score

    The EDSS ranges from 0 to 10, with higher scores indicating greater neurological disability.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  5. Proportion of Participants Without Confirmed Disability Progression

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  6. RMS: Proportion of Participants Who Remain Relapse-Free

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  7. Change from Baseline in Timed 25-Foot Walk(T25FW)

    Measured in seconds. A longer completion time indicates worse walking performance.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  8. Change from Baseline in Nine-Hole Peg Test(9HPT)

    Measured in seconds. A longer completion time indicates worse upper-extremity and manual dexterity performance.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  9. Change from Baseline in Multiple Sclerosis Functional Composite (MSFC) Score Description

    The MSFC score has no fixed minimum or maximum value, and higher scores indicate better neurological function.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  10. Change from Baseline in Modified Fatigue Impact Scale (MFIS) Score

    The 21-item MFIS total score ranges from 0 to 84, with higher scores indicating a greater impact of fatigue on daily functioning.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  11. Change from Baseline in VAS (Visual Analog Scale) Score

    Scores range from 0 to 10. Higher scores indicate greater pain severity.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  12. Change from Baseline in Multiple Sclerosis Quality of Life-54 (MSQOL-54) Score

    Scores range from 0 to 100, with higher scores indicating better quality of life.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  13. Change from Baseline in 36-Item Short Form Health Survey Score (SF-36)

    The SF-36 includes eight domains. Each domain score ranges from 0 to 100, with higher scores indicating better health status.

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  14. Change from Baseline in T2-Weighted Lesion Volume

    Measured: Baseline and Months 3, 6, 12, 18, and 24

  15. PMS: Brain Volume Loss from Baseline

    Measured: Baseline and Months 3, 6, 12, 18, and 24

  16. Number of New or Enlarging T2-Weighted Lesions

    Measured: Baseline and Months 3, 6, 12, 18, and 24

  17. RMS: Gadolinium-Enhancing Lesion Outcomes

    Measured: Baseline and Months 3, 6, 12, 18, and 24

  18. PK: BCMA CAR Transgene Copy Number in Peripheral Blood

    Quantified using quantitative polymerase chain reaction (qPCR)

    Measured: Before and immediately after the first, second, third, and fifth infusions; at 1, 2, 6, 24, 48, and 72 hours after the first and second infusions; and at 1 and 2 hours after the third and fifth infusions, as protocol specified.

  19. PK：BCMA CAR-Positive Cells in Peripheral Blood

    The absolute count and percentage of circulating BCMA CAR-positive cells in peripheral blood will be measured using flow cytometry

    Measured: Before and immediately after, and at 1 and 2 hours after the first, second, third, and fifth infusions.

  20. PK: BCMA CAR Transgene Copy Number in Cerebrospinal Fluid

    Quantified using qPCR

    Measured: At screening and within 1 to 3 hours after the fifth infusion

  21. Change from Baseline in Peripheral Blood B-Cell Subsets

    Measured: Baseline and Day 15, Months 1, 3, 9, 18, and 24

  22. Change from Baseline in Immunoglobulin Levels

    Measured: Baseline and Months 1, 3, 6, 9, 12, 18, and 24

  23. Incidence of Anti-CAR Antibodies

    Measured: Baseline and Day 15, Months 1, 3, 6, 9, 12, 18, and 24

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted10 Aug 2026
  2. Study start16 Sep 2026 (estimated)
  3. Primary completion7 Feb 2029 (estimated)
  4. Study completion7 Feb 2029 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
This trial is an investigator-initiated, single-arm, open-label Phase Ib/II study. A staggered enrollment and dosing strategy will be adopted in the early stage. Two early safety evaluation will be established (after the first 3 enrolled participants complete their first 3 infusions of SYS6020, and after the first 3 enrolled participants complete their first 6 infusions of SYS6020) for comprehensive assessment.
Masking
None (open label)
Enrolment
25 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07756268
Sponsor's protocol ID
SYS6020-005
Status last verified
Aug 2026
First submitted
30 Jul 2026
Last updated
10 Aug 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing SYS6020 injection in people with Multiple Sclerosis, run by Tongji Hospital at 1 site in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 36 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: opening soon, as of the sponsor's last update on 10 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Yuhang Cheng (+86-13125197960, chengyh_tj@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Safety and tolerability (time frame: From informed consent through Month 24). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07756268.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Aug 2026; AzTrials last refreshed its copy on 29 Oct 2026.

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