An Early Phase 1 interventional study of Universal BCMA CAR-T and Universal CD19 CAR-T in Neuromyelitis Optica Spectrum Disorders, Myasthenia Gravis, Generalized and Multiple Sclerosis, sponsored by Xuanwu Hospital, Beijing. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-01-01.
Sponsored by Xuanwu Hospital, Beijing · Early Phase 1, Interventional, and Treatment
Among 72 studies in Neuromyelitis Optica with a site in China — 37 open to participants now, 43 under way, 7 of them phase 3. Neuromyelitis Optica · China.
Among the 72 studies in Neuromyelitis Optica with a site in China, this one is the 25th largest by planned enrollment of the 51 interventional ones that give a count, is one of 10 that started in 2025, is one of 17 in phase 1, reaches primary completion later than 12 of the 42 other live ones, and was the 46th registered.
178 studies on the registry are indexed under Neuromyelitis Optica; 78 are open to participants now.
Browse Neuromyelitis Optica studies →37 of the 72 studies in Neuromyelitis Optica with a site in China are open now. Recruiting first, the newest first:
Alexion Pharmaceuticals, Inc. · Sites in China
Junwei Hao, MD · Sites in China
Hoffmann-La Roche · Sites in China, United States, Argentina and 6 more countries
Tongji Hospital · Sites in China
Chinese PLA General Hospital · Sites in China
A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →
Of the 50 Neuromyelitis Optica studies recruiting now, 29 (58%) set no upper age limit and 16 (32%) stop at 75 or younger; 11 take children under 18; 9 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
72 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 23 · Phase 2 17 · Phase 3 9 · Phase 4 6
First in 2009; this study’s year is marked. 10 started in 2025.
This study's planned enrollment of 25 is below the median of 29 across 108 interventional studies indexed under Neuromyelitis Optica.
Median enrollment 23 across the 51 interventional studies, 300 across the 21 observational. Of the 17 that completed or were terminated, 0 (0%) have results posted.
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18 of 72 have an industry lead sponsor. The 10 most frequent:
Xuanwu Hospital, Beijing is the lead sponsor of 363 studies on the registry; 230 are open to participants now.
Xuanwu Hospital, Beijing has 5 studies filed under Neuromyelitis Optica — fewer than ten, so there is no comparison to draw.
19 of the studies in Neuromyelitis Optica with a site in China that are under way reach primary completion within a year, 4 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06724809Phase 3Alexion Pharmaceuticals, Inc.Efficacy, Safety, PK, PD, and ADA of Eculizumab in Chinese Adults With NMOSD | 2026-12-07 |
| NCT07420296Phase 3Tianjin Medical University General HospitalModified Zipper Therapy for AQP4-IgG Positive Neuromyelitis Optica Spectrum Disorder | 2026-12-31 |
| NCT05199688Phase 3Hoffmann-La RocheA Study to Evaluate Pharmacokinetics, Efficacy, Safety, Tolerability, and Pharmacodynamics of Satralizumab in Pediatric Patients With Aquaporin-4 Antibody Positive Neuromyelitis Optica Spectrum Disorder (NMOSD) | 2027-03-31 |
| NCT06413654Phase 3Shanghai Jiaolian Drug Research and Development Co., LtdA Clinical Study of B001 Injection in the Treatment of Neuromyelitis Optica Spectrum Disorders(NMOSD) | 2027-10-31 |
| NCT05145361Shanghai Pharmaceuticals Holding Co., LtdClinical Study of B001 Injection in Subjects With Neuromyelitis Optic Spectrum Disorder (NMOSD) | 2026-12-15 |
Among the 72 studies in Neuromyelitis Optica with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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This is an open label, single-site, dose-escalation study in up to 25 participants with refractory autoimmune diseases of nervous system. This study aims to evaluate the safety and efficacy of the treatment with universal BCMA and CD19 CART.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Relapsed and refractory
Relapsed: the illness came back after treatment had worked. Refractory: it did not respond to treatment, or stopped responding while still on it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Universal BCMA CAR-T
Drug: Universal BCMA CAR-T
Universal CD19 CAR-T
Drug: Universal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
Drug: Universal BCMA CAR-T; Universal CD19 CAR-T
Universal BCMA CAR-T
Universal CD19 CAR-T
Universal BCMA CAR-T; Universal CD19 CAR-T
Incidence of dose-limiting toxicities(DLTs)
Incidence of dose-limiting toxicities(DLTs)
Time frame: First 28 days after infusion
Incidence of adverse events(AEs) and severe adverse
Incidence of adverse events(AEs) and severe adverse events(SAEs).
Time frame: Up to 12 months after infusion
Concentrations of UCAR-T cells
The concentration of BCMA UCAR T cells and CD19 UCAR-T cells in peripheral blood after infusion
Time frame: 3 months
B cell levels in peripheral blood
The change of B cell levels in peripheral blood after infusion
Time frame: 3 months
Changes of pathogenic antibody titers after infusion
The changes of pathogenic antibody titers in peripheral blood or cerebrospinal fluid.
Time frame: 1, 3, 6 ,12months
NMOSD: Annualized relapse rate
ARR is defined as the number of relapses divided by the total participant-years after infusion
Time frame: 6, 12months
gMG: Changes of Myasthenia Gravis Activities if Daily Living (MG-ADL) Score
MG-ADL scale assesses the impact of gMG on daily functions by measuring 8 signs or symptoms that are commonly affected in gMG. Each item is measured on a 4-point scale, where a score of 0 represents normal function and a score of 3 represents the loss of ability to perform that function. Total scores range from 0 to 24 points, with a higher score showing more severe gMG.
Time frame: 1, 3, 6, 12months
CIDP:Changes of Inflammatory Neuropathy Cause and Treatment (INCAT) Score after infusion.
The INCAT score assesses the functionality of the arms and legs by giving a 0-5 score for arms and legs, with 0 representing no disability and 5 representing no arm function or inability to stand/walk.
Time frame: 1, 3, 6, 12months
MS: Changes of the number of Gd-enhancing T1 Lesions
The changes of enhancing Lesions as detected by brain Magnetic Resonance Imaging (MRI)
Time frame: 6, 12months
MS: Changes of the number of Number of New or Enlarging T2 Lesions
Number of new/enlarging T2 lesions on last available MRI scan compared to baseline.
Time frame: 6, 12months
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Feb 2025; primary completion for Dec 2026, 22 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2024. You cannot join it, but the record below documents what was studied.
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