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Tests treatment safety and results for Multiple Sclerosis (MS)
Official title Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
ClinicalTrials.gov ID: NCT07526493
What this study is testing
What is Universal CD19 CAR-γδT Cell Injection?
Universal CD19 CAR-γδT Cell Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for multiple sclerosis (ms).
Also referred to as QH103 Cell Injection.
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 an open-label, exploratory, prospective clinical trial with dose escalation(according to "3+3" design), to evaluate the safety and tolerability of QH103(Universal CD19 CAR-γδT Cell Injection)in the treatment of recurrent/refractory antibody-mediated neurological autoimmune diseases.
- 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 75
You may be able to join if
- Common
- Aged 18-75 years (inclusive), any gender.
- Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or practice...
- The subject's expected survival, as judged by the investigator, is ≥12 weeks.
- Voluntarily participate in this trial and sign the informed consent form. Disease-Specific 1、Multiple Sclerosis (MS): Clinically confirmed as...
You likely can't join if
- History of severe drug allergy or allergic diathesis.
- Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Organ function that does not meet the following requirements (except for abnormalities caused by the autoimmune disease itself):
- Bone Marrow Function: White blood cell count ≥1×10⁹/L; absolute neutrophil count ≥1×10⁹/L (no treatment with colony-stimulating factors within 2...
- Liver Function: ALT ≤3×ULN (except if elevated due to inflammatory myopathy); AST ≤3×ULN (except if elevated due to inflammatory myopathy); Indirect...
- Renal Function: Creatinine clearance (CrCl) ≥30 mL/min (eGFR ≥30 mL/min/1.73m²) (calculated by Cockcroft-Gault formula, except for acute decreases in...
See the full eligibility criteria
Who can join
- Common
- Aged 18-75 years (inclusive), any gender.
- Female people of childbearing potential and male people with partners of childbearing potential must use medically approved contraception or practice abstinence during the study treatment period and for at least 6...
- The subject's expected survival, as judged by the investigator, is ≥12 weeks.
- Voluntarily participate in this trial and sign the informed consent form. Disease-Specific 1、Multiple Sclerosis (MS): Clinically confirmed as progressive MS (including Primary Progressive PPMS or Secondary Progressive...
- Two relapses were recorded within the first 2 years of screening;
- One recurrence was recorded within the first year prior to screening;
- Select the results of Gd-enhanced MRI scans that were positive within the previous year (if there is no record of a positive Gd-enhanced scan in the previous year, the results of the screening MRI scan can be used)...
- Treatment with at least one immunosuppressant for over 1 year, or intolerance to immunosuppressant treatment, with suboptimal symptom control.
- At least 2 documented relapses within the last 12 months, or 3 documented relapses within the last 24 months with at least 1 relapse occurring within the 12 months prior to screening. 3、Autoimmune Encephalitis (AE)...
- Positive for at least one relevant autoantibody;
- Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody);
- An episode of autoimmune encephalitis within 3 months prior to signing the informed consent form;
- Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2 or a CASE score ≥ 4 . 4、Chronic Inflammatory Demyelinating Polyneuropathy (CIDP): Participants diagnosed with antibody-positive CIDP...
- Inadequate symptom control despite standardized use of at least one first-line therapy (corticosteroids, intravenous immunoglobulin, or plasma exchange) for over 3 months;
- Intolerance to corticosteroids, intravenous immunoglobulin, and plasma exchange due to side effects or other reasons. 5、Myasthenia Gravis (MG): Participants diagnosed with antibody-positive MGFA Class II-IV Myasthenia...
- Standardized treatment with at least one immunosuppressant for over 1 year, with one of the following indicating inadequate control: (1) persistent weakness affecting daily life, (2) worsening MG symptoms and/or crisis...
- Requiring maintenance therapy with plasma exchange or intravenous immunoglobulin. 6、Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody----- - Associated Disease (MOGAD): Participants with a clinical...
- Positive for MOG autoantibody via cell-based assay (CBA);
- Disability status at screening meeting a modified Rankin Scale (mRS) score ≥ 2.
- Inadequate symptom control with or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant / immunomodulator (including CD20 monoclonal antibody). 7、Idiopathic Inflammatory...
- Treatment with corticosteroids for at least 1 month, combined with standardized use of at least one immunosuppressant/immunomodulator (e.g., azathioprine, methotrexate, mycophenolate mofetil, cyclosporine, tacrolimus...
- Intolerance to the aforementioned conventional treatment regimens due to side effects or other reasons.
What rules you out
- History of severe drug allergy or allergic diathesis.
- Presence of or suspected uncontrolled or treatment-requiring fungal, bacterial, viral, or other infections.
- Organ function that does not meet the following requirements (except for abnormalities caused by the autoimmune disease itself):
- Bone Marrow Function: White blood cell count ≥1×10⁹/L; absolute neutrophil count ≥1×10⁹/L (no treatment with colony-stimulating factors within 2 weeks prior to the test); hemoglobin ≥60 g/L.
- Liver Function: ALT ≤3×ULN (except if elevated due to inflammatory myopathy); AST ≤3×ULN (except if elevated due to inflammatory myopathy); Indirect bilirubin (IBIL) ≤1.5×ULN (except for Gilbert's syndrome); Total...
- Renal Function: Creatinine clearance (CrCl) ≥30 mL/min (eGFR ≥30 mL/min/1.73m²) (calculated by Cockcroft-Gault formula, except for acute decreases in CrCl due to the disease itself).
- Coagulation Function: International normalized ratio (INR) ≤1.5×ULN; Prothrombin time (PT) ≤1.5×ULN.
- Cardiac Function: Left ventricular ejection fraction (LVEF) ≥55% and no clinically significant cardiac disease.
- people with a history indicative of congenital immunoglobulin deficiency.
- History of active/unresolved malignant tumors within the past 5 years.
- people who are positive for hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) with peripheral blood HBV DNA titer above the detection limit; positive for hepatitis C virus (HCV) antibody with...
- History of definite psychiatric disorders or history of substance abuse involving psychotropic drugs that cannot be discontinued.
- Participation in any other clinical trial within 3 months prior to enrollment.
- Prior treatment with CAR-T cell therapy.
- History of severe adverse reactions to cyclophosphamide or fludarabine.
- History of other autoimmune diseases (e.g.,Crohn's disease, systemic lupus erythematosus) that, within the past 2 years, have resulted in end-organ damage or required systemic immunosuppressive therapy (excluding the...
- Myasthenia gravis crisis not effectively controlled within 2 weeks prior to enrollment.
- History of cerebrovascular accident, including transient ischemic attack or stroke, within 6 months prior to enrollment.
- Male or female participants unwilling to practice contraception from the time of informed consent until 6 months after treatment completion.
- Any medical condition that may interfere with the assessment of the safety or how well it works of the study treatment.
- History of symptomatic deep vein thrombosis or pulmonary embolism within 6 months prior to enrollment, requiring systemic anticoagulation therapy.
- Any other condition that, in the investigator's judgment, makes the subject unsuitable for participation in this study.
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, 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 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, 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.