Multiple Sclerosis (MS)Phase 1NCT07526493
Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
A Phase 1 study testing Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide and Fludarabine in people with Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorder (NMOSD), run by Tongji Hospital at 1 site in China.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE)
- What is being tested?
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide and Fludarabine
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 6 participants
- Where
- 1 siteChina
- Study dates
- 1 Apr 2026to 31 Dec 2028
- Phase
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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 bilirubin ≤3.0×ULN.
- 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).
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- 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.
- Subjects with a history indicative of congenital immunoglobulin deficiency.
- History of active/unresolved malignant tumors within the past 5 years.
- Subjects 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 detectable peripheral blood HCV RNA; positive for human immunodeficiency virus (HIV) antibody; or positive for Treponema pallidumserology.
- 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 disease populations specified for enrollment in the study protocol).
- 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 efficacy 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.
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
Daishi Tian
Daishi Tian
About this study
Official title: An Open-Label Clinical Study to Evaluate the Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
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.
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Myasthenia Gravis (MG), Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)
- Being tested
- Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide, Fludarabine
- Medical subject headings
- Multiple Sclerosis, Neuromyelitis Optica, Autoimmune Diseases of the Nervous System, Polyradiculoneuropathy, Chronic Inflammatory Demyelinating, Myasthenia Gravis, Myositis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Universal CD19 CAR-γδT Cell InjectionBiological
Also called QH103 Cell Injection
Biological: Allogeneic CD19 CAR-γδT cell following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated
CyclophosphamideDrug
Subjects will receive cyclophosphamide infusion on Days -5 to -3 prior to cell infusion.
FludarabineDrug
Subjects will receive fludarabine infusion on Days -5 to -3 prior to cell infusion.
| Study group | Role | What they receive |
|---|---|---|
| Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases | Experimental | Not described Receives: Biological: Universal CD19 CAR-γδT Cell Injection; Drug: Cyclophosphamide; Drug: Fludarabine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Dose-Limiting Toxicities (DLTs)
DLT was defined as QH103-related events with onset within first 28 days.
Measured: First infusion date of QH103 up to 28 days
Adverse Event
AE is defined as any adverse medical event from the date the subject receives lymphodepleting chemotherapy to 12months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
Measured: 12 months
Secondary outcomes (2)
PK(Pharmacokinetics): Number and Copy Number of CD19 CAR-γδT cells
Number and copy number of CD19 CAR-γδT cells were assessed by number in peripheral blood. Blood samples were collected before and one year after cell infusion (until CD19 CAR-γδT cells were not detected for two consecutive times) to detect the number and copy number of CD19 CAR-γδT cells, and to evaluate the pharmacokinetics of CD19 CAR-γδT.
Measured: 12 months
PD(Pharmacodynamics) ：Changes in cytokines and chemokines over time
Changes in cytokines and chemokines (such as IL-2, IL-4, IL-6, IFN-γ, and TNF-α) over time
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study start1 Apr 2026
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tongji Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Daishi Tian, Tongji Hospital
- Investigators
- Daishi Tian, Principal investigator, Tongji HospitalChuan Qin, Principal investigator, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07526493
- Sponsor's protocol ID
- QH10310-NADs-01（0）
- Status last verified
- Apr 2026
- First submitted
- 3 Apr 2026
- Last updated
- 12 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
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
- An Open-Label Clinical Study to Evaluate the Safety and Pharmacodynamics of QH103 Cell Injection in the Treatment of Patients With Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases.
- ClinicalTrials.gov ID
- NCT07526493
- Acronym / sponsor ID
- QH10310-NADs-01（0）
- Conditions
- Multiple Sclerosis (MS), Neuromyelitis Optica Spectrum Disorder (NMOSD), Autoimmune Encephalitis (AE), Chronic Inflammatory Demyelinating Polyneuropathy (CIDP), Myasthenia Gravis (MG), Anti-Myelin Oligodendrocyte Glycoprotein Immunoglobulin G Antibody-Associated Disease (MOGAD)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Tongji HospitalUniversity, hospital or other
- Study start
- 1 Apr 2026 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 13 Apr 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 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases | Experimental | Biological: Universal CD19 CAR-γδT Cell Injection, Drug: Cyclophosphamide, Drug: Fludarabine |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (22 listed)
- 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):
- Subjects with a history indicative of congenital immunoglobulin deficiency.
- History of active/unresolved malignant tumors within the past 5 years.
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 |
|---|---|---|
| Universal CD19 CAR-γδT Cell InjectionAlso: QH103 Cell InjectionBiological: Allogeneic CD19 CAR-γδT cell following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated | Biological | Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases |
| CyclophosphamideSubjects will receive cyclophosphamide infusion on Days -5 to -3 prior to cell infusion. | Drug | Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases |
| FludarabineSubjects will receive fludarabine infusion on Days -5 to -3 prior to cell infusion. | Drug | Patients with Relapsed/Refractory Antibody-Mediated Neurological Autoimmune Diseases |
Primary outcome
Incidence of Dose-Limiting Toxicities (DLTs)
Time frame: First infusion date of QH103 up to 28 days
DLT was defined as QH103-related events with onset within first 28 days.
Adverse Event
Time frame: 12 months
AE is defined as any adverse medical event from the date the subject receives lymphodepleting chemotherapy to 12months after QH103 infusion. Among them, cytokine release syndrome (CRS) and immune cell-associated neurotoxicity syndrome (ICANS) were graded according to American Society for Transplantation and Cellular Therapy (ASTCT) criteria, graft-versushost disease (GVHD) according to criteria defined by the Mount Sinai Acute GVHD International Consortium. Other AEs were graded according to common terminology criteria for adverse events (CTCAE) v5.0
2 secondary outcomes
PK(Pharmacokinetics): Number and Copy Number of CD19 CAR-γδT cells
Time frame: 12 months
PD(Pharmacodynamics) ：Changes in cytokines and chemokines over time
Time frame: 12 months
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. Access to the data underlying this study can be obtained from the corresponding author upon reasonable request and subject to any required ethical approvals.
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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 principal investigator
Tongji Hospital
Chuan Qin 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 Phase 1 study testing Universal CD19 CAR-γδT Cell Injection, Cyclophosphamide and Fludarabine in people with Multiple Sclerosis (MS) and Neuromyelitis Optica Spectrum Disorder (NMOSD), 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 0 inclusion and 22 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?
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.
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 Daishi Tian (+86 13607178809, tiands@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Dose-Limiting Toxicities (DLTs) (time frame: First infusion date of QH103 up to 28 days). The study lists 2 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.