Relapsing or Refractory Multiple Sclerosis (MS)Early Phase 1NCT07337785
CD19/BCMA-Targeted UCAR-T for Patients With Neurological Autoimmune Diseases
A Early Phase 1 study testing CD19/BCMA-targeted CAR-T cells and Lymphodepleting Conditioning in people with Relapsing or Refractory Multiple Sclerosis (MS) and Myasthenia Gravis (MG), run by Tongji Hospital at 1 site in China.
Trial summary
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Relapsing or Refractory Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)
- What is being tested?
- CD19/BCMA-targeted CAR-T cells and Lymphodepleting Conditioning
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteChina
- Study dates
- 12 Dec 2025to 1 Nov 2028
- Phase
- Early Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. According to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis (AE), the patient is clinically diagnosed with autoimmune encephalitis and meets all the following requirements: Positive result in the detection of at least one relevant autoantibody; Poor symptom control or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody); Occurrence of an autoimmune encephalitis attack within 3 months before signing the informed consent form; At the time of screening, the disability status meets either a modified Rankin Scale (mRS) score of ≥ 2 or a Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score of ≥ 4.
Who cannot join
- Primary diagnosis of an autoimmune disease different from the study disease, which the investigator believes may confound the efficacy evaluation of the study disease.
- Comorbidity with other clinically significant central nervous system (CNS) diseases or pathological changes prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs/cells.
- For MG patients: Uncontrolled myasthenic crisis within 2 weeks prior to screening.
- For CIDP patients: Pure sensory CIDP.
- Presence of clinically significant cardiovascular dysfunction within 12 months prior to screening, including but not limited to: New York Heart Association (NYHA) Class III or IV heart failure, myocardial infarction, unstable angina pectoris, uncontrolled or symptomatic atrial arrhythmia, or any ventricular arrhythmia.
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- Presence of significant pulmonary or cardiac manifestations (e.g., pericarditis, pleural effusion) at screening, which the investigator assesses as making the patient unsuitable for participation in this study.
- Patients with severe asthma or chronic obstructive pulmonary disease (COPD); patients with mild or moderate asthma or COPD receiving stable treatment are eligible for enrollment.
- History of malignancy within 5 years prior to signing the ICF, except for fully treated or surgically resected non-melanoma skin cancer or carcinoma in situ (e.g., cervical cancer, bladder cancer, breast cancer) with no residual disease.
- Pregnant or lactating females.
- History of recurrent infections requiring hospitalization and intravenous antibiotics (e.g., 3 or more infections of the same type within the past year).
- Active infection requiring systemic treatment (e.g., infectious pneumonia, tuberculosis) within 2 weeks prior to lymphodepletion.
- Positive for hepatitis B surface antigen (HBsAg); or positive for hepatitis B core antibody (HBcAb) with positive hepatitis B virus (HBV) DNA detection in peripheral blood; positive for hepatitis C virus (HCV) antibody with positive HCV RNA in peripheral blood; positive for human immunodeficiency virus (HIV) antibody; positive for syphilis antibody.
- Vaccination with live-attenuated vaccines within 4 weeks prior to lymphodepletion, or planned vaccination with live-attenuated vaccines during the study.
- Receipt of high-dose corticosteroids (prednisone ≥ 60 mg/day or equivalent dose) within 4 weeks prior to lymphodepletion, or inability to taper prednisone to ≤ 20 mg/day gradually within 3 days prior to lymphodepletion.
- Inability to taper or discontinue background treatment gradually prior to lymphodepletion chemotherapy, as described in Table 3.
- Receipt of plasma exchange, immunoadsorption, or intravenous immunoglobulin (IVIG) treatment within 4 weeks prior to screening.
- A history of allergy or intolerance to calcineurin inhibitors used previously.
- Receipt of renal replacement therapy within 3 months prior to screening, or expected need for renal replacement therapy during the study.
- History of drug or alcohol abuse within 1 year prior to screening.
- History or evidence of suicidal ideation within 6 months prior to screening, or any suicidal behavior within the previous 12 months, with the investigator determining a significant suicide risk.
- Use of other investigational drugs within 4 weeks or 5 half-lives (whichever is longer) prior to screening.
- A history of hypersensitivity or life-threatening reactions to any component or formulation of the study drug or study treatment (including lymphodepletion chemotherapy). For detailed information on the components of the study drug, please refer to the Investigator's Brochure (IB).
- Any other condition deemed by the investigator to potentially affect study participation, pose a safety risk to the patient, or potentially confound the interpretation of study results.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Ke Shang, 027-83663337, kay_sang@qq.com
Daishi Tian, Prof.
About this study
Official title: Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Neurological Autoimmune Diseases
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders.
In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data.
For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.
- Conditions
- Relapsing or Refractory Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE)
- Being tested
- CD19/BCMA-targeted CAR-T cells, Lymphodepleting Conditioning
- Medical subject headings
- Recurrence, Multiple Sclerosis, Myasthenia Gravis, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Autoimmune Diseases of the Nervous System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CD19/BCMA-targeted CAR-T cellsBiological
Also called RD06-05
Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of CD19/BCMA-targeted CAR-T cells (RD06-05) at dose of 1 × 10^7 CAR+ T cells/kg (Additional dose levels will be determined by safety, PK/PD, and preliminary efficacy).
Lymphodepleting ConditioningDrug
From Day -5 to Day -3 prior to cell infusion (Day 0), subjects will receive chemotherapy preconditioning based on the "Fludarabine + Cyclophosphamide" (FC regimen). The recommended preconditioning regimen is as follows:
Fludarabine: 30 mg/m² per day, once daily for 3 consecutive days; Cyclophosphamide: 300 mg/m² per day, once daily for 3 consecutive days;
| Study group | Role | What they receive |
|---|---|---|
| CART Treatment Group | Experimental | Participants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide from Day -5 to Day -3, followed by a single intravenous infusion of RD06-05. Receives: Biological: CD19/BCMA-targeted CAR-T cells; Drug: Lymphodepleting Conditioning |
What is being measured
The primary outcome is the main question the study is designed to answer.
The incidence rates of Treatment-Emergent Adverse Events (TEAEs)
Measured: From the start of cell infusion to 24 months after infusion
Serious Adverse Events (SAEs)
Measured: From the start of cell infusion to 24 months after infusion
The incidence rate of Adverse Events of Special Interest (AESI)
Measured: From the start of cell infusion to 24 months after infusion
Secondary outcomes (22)
MS:Time to first relapse; Annual Relapse Rate (ARR)
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The number of new or enlarged T2 lesions on MRI during the study;
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The number of newly emerged gadolinium-enhancing lesions on MRI
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The change in Expanded Disability Status Scale (EDSS) score from baseline during the study
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MG: Changes in Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) scores compared to baseline
Measured: At Week 12, and Months 6, 12, 18, and 24 post infusion
MG: Changes in Quantitative Myasthenia Gravis Score (QMG) scores compared to baseline
Measured: At Week 12, and Months 6, 12,18, and 24 post infusion
MG: The proportion of patients with a change of ≥2 points in MG-ADL scores
Measured: Months 12 and 24 post infusion
MG: The proportion of patients with a change of ≥3 points in Myasthenia Gravis Composite Scale (MGC) score
Measured: Months 12 and 24 post infusion
MG: Changes in the titer of MG serum-specific autoantibodies compared to baseline
Measured: Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score compared to baseline
Measured: At Week 12, and Months 6, 12, 18, and 24 post infusion
CIDP: Changes in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) score compared to baseline
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in average grip strength compared to baseline
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in Medical Research Council Scale (MRC) score compared to baseline
Measured: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
Changes from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Measured: Months 6, 12, 18, and 24 post infusion
Changes from baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Measured: Months 6, 12, 18, and 24 post infusion
Peak expansion (Cmax)
Measured: Days 0, 4, 7, 10, Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
Area under the curve (AUC₀-₂₈)
Measured: Days 0, 4, 7, 10, 14, 21, and Day 28 post infusion.
AE: Changes in CASE score from baseline
Measured: Months 6, 12, 18, and 24 post infusion
AE: Changes in MoCA scores from baseline
Measured: Month 6, 12, 18, and 24 post infusion
Changes in CGI score from baseline
Measured: Month 6, 12, 18, and 24 post infusion
AE: Changes in GCS score from baseline
Measured: Month 6, 12, 18, and 24 post infusion
Changes in MMSE score from baseline
Measured: Monthe 6, 12,18, and 24 post infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jan 2026
- Study start12 Dec 2025
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Relapsing or Refractory Multiple Sclerosis (MS)Studies of the same condition, open and under way.
- More trials run by Tongji HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- This is a single-group assignment design. All eligible participants undergo lymphodepleting chemotherapy followed by a single intravenous infusion of RD06-05. The trial includes multiple disease cohorts (MS, MG, AE, and CIDP), but all participants receive the same intervention without randomization or comparator arms.
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
- Investigators
- Daishi Tian, Prof., Principal investigator, Tongji HospitalChuan Qin, Prof., Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07337785
- Sponsor's protocol ID
- BHCT-RD06-05-NI-01
- Status last verified
- Jan 2026
- First submitted
- 5 Dec 2025
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Study on the Safety, Efficacy, and Pharmacokinetics of Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Neurological Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07337785
- Acronym / sponsor ID
- BHCT-RD06-05-NI-01
- Conditions
- Relapsing or Refractory Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Collaborators
- Nanjing Bioheng Biotech Co., Ltd.
- Study start
- 12 Dec 2025 (actual)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Nov 2028 (estimated)
- First posted
- 13 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-arm, open-label investigator-initiated trial (IIT) evaluates the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with autoimmune neurological diseases, including Multiple Sclerosis (MS), Myasthenia Gravis (MG), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Autoimmune Encephalitis (AE), and other B-cell-mediated neuroautoimmune disorders.
In this study, the dose of CAR-T cells administered is 10×10⁶ CAR⁺T cells per kilogram of body weight. Investigators may decide whether to add other dose groups based on the subjects' safety data, pharmacokinetic (PK) data, pharmacodynamic (PD) data, and preliminary efficacy data.
For each indication, 6 to 9 subjects will be enrolled, with a total of 24 to 36 subjects planned for enrollment in the entire study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This is a single-group assignment design. All eligible participants undergo lymphodepleting chemotherapy followed by a single intravenous infusion of RD06-05. The trial includes multiple disease cohorts (MS, MG, AE, and CIDP), but all participants receive the same intervention without randomization or comparator arms.
| Arm | Type | Receives |
|---|---|---|
| CART Treatment Group | Experimental | Biological: CD19/BCMA-targeted CAR-T cells, Drug: Lymphodepleting ConditioningParticipants receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide from Day -5 to Day -3, followed by a single intravenous infusion of RD06-05. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. According to the 2016 International Diagnostic Criteria for Autoimmune Encephalitis (AE), the patient is clinically diagnosed with autoimmune encephalitis and meets all the following requirements: Positive result in the detection of at least one relevant autoantibody; Poor symptom control or intolerance to previous standardized treatment with glucocorticoids and at least one immunosuppressant/immunomodulator (including CD20 monoclonal antibody); Occurrence of an autoimmune encephalitis attack within 3 months before signing the informed consent form; At the time of screening, the disability status meets either a modified Rankin Scale (mRS) score of ≥ 2 or a Clinical Assessment Scale in Autoimmune Encephalitis (CASE) score of ≥ 4.
Key exclusion criteria (24 listed)
- Primary diagnosis of an autoimmune disease different from the study disease, which the investigator believes may confound the efficacy evaluation of the study disease.
- Comorbidity with other clinically significant central nervous system (CNS) diseases or pathological changes prior to screening, including but not limited to: cerebrovascular accident, aneurysm, epilepsy, convulsions/seizures, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, or psychosis.
- History of allogeneic bone marrow or stem cell transplantation, or solid organ transplantation (e.g., kidney, lung, heart, liver), or planned future transplantation of such organs/cells.
- For MG patients: Uncontrolled myasthenic crisis within 2 weeks prior to screening.
- For CIDP patients: Pure sensory CIDP.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CD19/BCMA-targeted CAR-T cellsAlso: RD06-05Participants will receive lymphodepleting chemotherapy with fludarabine and cyclophosphamide followed by a single intravenous infusion of CD19/BCMA-targeted CAR-T cells (RD06-05) at dose of 1 × 10^7 CAR+ T cells/kg (Additional dose levels will be determined by safety, PK/PD, and preliminary efficacy). | Biological | CART Treatment Group |
| Lymphodepleting ConditioningFrom Day -5 to Day -3 prior to cell infusion (Day 0), subjects will receive chemotherapy preconditioning based on the "Fludarabine + Cyclophosphamide" (FC regimen). The recommended preconditioning regimen is as follows: Fludarabine: 30 mg/m² per day, once daily for 3 consecutive days; Cyclophosphamide: 300 mg/m² per day, once daily for 3 consecutive days; | Drug | CART Treatment Group |
Primary outcome
The incidence rates of Treatment-Emergent Adverse Events (TEAEs)
Time frame: From the start of cell infusion to 24 months after infusion
Serious Adverse Events (SAEs)
Time frame: From the start of cell infusion to 24 months after infusion
The incidence rate of Adverse Events of Special Interest (AESI)
Time frame: From the start of cell infusion to 24 months after infusion
22 secondary outcomes
MS:Time to first relapse; Annual Relapse Rate (ARR)
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The number of new or enlarged T2 lesions on MRI during the study;
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The number of newly emerged gadolinium-enhancing lesions on MRI
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MS: The change in Expanded Disability Status Scale (EDSS) score from baseline during the study
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
MG: Changes in Myasthenia Gravis Activities of Daily Living Scale (MG-ADL) scores compared to baseline
Time frame: At Week 12, and Months 6, 12, 18, and 24 post infusion
MG: Changes in Quantitative Myasthenia Gravis Score (QMG) scores compared to baseline
Time frame: At Week 12, and Months 6, 12,18, and 24 post infusion
MG: The proportion of patients with a change of ≥2 points in MG-ADL scores
Time frame: Months 12 and 24 post infusion
MG: The proportion of patients with a change of ≥3 points in Myasthenia Gravis Composite Scale (MGC) score
Time frame: Months 12 and 24 post infusion
MG: Changes in the titer of MG serum-specific autoantibodies compared to baseline
Time frame: Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in Inflammatory Neuropathy Cause and Treatment disability scale (INCAT) score compared to baseline
Time frame: At Week 12, and Months 6, 12, 18, and 24 post infusion
CIDP: Changes in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) score compared to baseline
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in average grip strength compared to baseline
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
CIDP: Changes in Medical Research Council Scale (MRC) score compared to baseline
Time frame: Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
Changes from baseline in the Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-Fatigue)
Time frame: Months 6, 12, 18, and 24 post infusion
Changes from baseline in the Health Assessment Questionnaire - Disability Index (HAQ-DI)
Time frame: Months 6, 12, 18, and 24 post infusion
Peak expansion (Cmax)
Time frame: Days 0, 4, 7, 10, Day 14, Day 28, Week 8, Week 12, Month 6, Month 9, Month 12, Month 18, and Month 24 post infusion
Area under the curve (AUC₀-₂₈)
Time frame: Days 0, 4, 7, 10, 14, 21, and Day 28 post infusion.
AE: Changes in CASE score from baseline
Time frame: Months 6, 12, 18, and 24 post infusion
AE: Changes in MoCA scores from baseline
Time frame: Month 6, 12, 18, and 24 post infusion
Changes in CGI score from baseline
Time frame: Month 6, 12, 18, and 24 post infusion
AE: Changes in GCS score from baseline
Time frame: Month 6, 12, 18, and 24 post infusion
Changes in MMSE score from baseline
Time frame: Monthe 6, 12,18, and 24 post infusion
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Daishi Tian, Prof. principal investigator
Tongji Hospital
Chuan Qin, Prof. principal investigator
Tongji Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing CD19/BCMA-targeted CAR-T cells and Lymphodepleting Conditioning in people with Relapsing or Refractory Multiple Sclerosis (MS) and Myasthenia Gravis (MG), 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 1 inclusion and 24 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: looking for participants now, as of the sponsor's last update on 12 May 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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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 Ke Shang (027-83663337, kay_sang@qq.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence rates of Treatment-Emergent Adverse Events (TEAEs) (time frame: From the start of cell infusion to 24 months after infusion). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 12 May 2026.