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Research summary · AI summary · not yet reviewedHuman studyInterventionalTrial registry record – peer review not applicable
Human Study on Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy
The study intended to evaluate the safety of an CAR T-cell therapy for MS but was withdrawn due to no participants enrolling.
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- #MSResearch
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This plain-English summary was written by AI from a trial registry record and may contain errors. It is not medical advice. Read the original study and talk to your MS team before making decisions about treatment.
- Human efficacy
- Not yet assessed
- Mechanism
- Not yet assessed
- Evidence strength
- Not yet assessed
- Outcome
- Not yet assessed
Why it matters
This withdrawal highlights challenges in recruiting for clinical studies in MS, which can affect the development of potential therapies.
What this does not prove
No results were posted, and planned enrollment does not constitute findings, limiting insights into the therapy's safety or efficacy.
Next milestone
No next milestone was established from the available source.
Study facts
- Study design
- Interventional
- Participants / samples
- Not reported
- Randomised
- Not applicable
- Controlled
- Not applicable
- Primary endpoint met
- Not reported
- Relevant MS type
- Not reported
- Publication date
- Not reported
- Evidence reviewed
- Trial registry record
- Regulatory approval
- No
- Research areas
- Not classified
Original sources
Supporting passages (10)
study design"studyType": "INTERVENTIONAL"
subjects3.5 Relapsed/Refractory Autoimmune Hemolytic Anemia (AIHA)\n\n Participants must meet all of the following:\n\n(1) Diagnosis consistent with the Chinese Guidelines for the Diagnosis and Treatment of Adult Autoimmune Hemolytic Anemia (2023 Edition).\n\n(2) Evidence of hemolysis, including: anemia based on hemoglobin level; reduced haptoglobin (\\<250 mg/L), elevated total bilirubin (≥17.1 μmol/L, predominantly indirect), elevated lactate dehydrogenase (LDH), and reticulocyte percentage \\>4% or absolute reticulocyte count \\>120 × 10\\^9/L; and detection of red blood cell autoantibodies.\n\n(3) Relapsed/refractory disease defined as inadequate response, intolerance, contraindication, or relapse after ≥3 months of treatment with glucocorticoids combined with at least one immunosuppressive agent (e.g., cyclophosphamide, azathioprine, vinca alkaloids, calcineurin inhibitors, mycophenolate mofetil) and/or rituximab.\n\n3.6 Relapsed/Refractory Multiple Sclerosis (MS)\n\nParticipants must meet all of the following:\n\n(1) Diagnosis of MS according to the Chinese Guidelines for the Diagnosis and Treatment of Multiple Sclerosis (2023 Edition).\n\n(2) Evidence of disease activity, meeting at least two of the following: (a) clinical relapse within the past 12 months confirmed by a neurologist; (b) MRI activity, including ≥1 new or enlarging T2 lesion or ≥1 new gadolinium-enhancing T1 lesion; (c) disability progression defined by an increase in EDSS score from baseline (≥1.0 point if baseline EDSS ≥1.0; ≥1.5 points if baseline EDSS = 0), sustained for ≥6 months and not attributable to a single relapse.\n\n(3) Relapsed/refractory disease despite ≥12 months of disease-modifying therapy (DMT), including inadequate response, intolerance, contraindication, or relapse during or after treatment discontinuation.\n\n4\\.
randomized"allocation": "NA"
controlled"masking": "NONE"
regulatory approval"isFdaRegulatedDrug": false
intervention"name": "Autologous CD19-BCMA Dual-Target CAR T-Cell Therapy"
primary endpoint"measure": "Number and percentage of participants with adverse events (AEs), serious adverse events (SAEs), laboratory abnormalities, and adverse events of special interest (AESIs: CRS and ICANS), graded per CTCAE v5.0 and ASTCT 2019 criteria",
follow up"timeFrame": "From Day 0 through Month 24 after infusion (including Day 1-28 observation and Month 2-24 follow-up)."
findings"overallStatus": "WITHDRAWN", "whyStopped": "No participants."
limitationsPlanned enrolment and endpoints are not findings.
AI assessment, not yet reviewed by a person · version 1 · Community votes are separate from evidence review.