Generalized Myasthenia Gravis (gMG)Early Phase 1NCT07058298
GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis(24103)
A Early Phase 1 study testing GC012F injection in people with Generalized Myasthenia Gravis (gMG), run by Daishi Tian at 1 site in China.
Trial summary
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Generalized Myasthenia Gravis (gMG)
- What is being tested?
- GC012F injection
- 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
- 15 Jul 2025to 10 Sep 2027
- 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- To be enrolled, subjects must meet all of the following criteria:
- Subjects or their legal representatives voluntarily sign a written informed consent and are willing and able to comply with the procedures of the study;
- Subjects aged 18-75 years old (both inclusive), male or female;
- Subjects with confirmed refractory gMG of classes IIa - IVb by MGFA clinical classification (including classes IIa, IIb, IIIa, IIIb, IVa and IVb) at screening;
- Subjects with the Myasthenia Gravis - Activities of Daily Living (MG-ADL) score of ≥6, the proportion of ocular symptoms of <50% of the total score, and the Quantitative Myasthenia Gravis (QMG) score of ≥11;
- Subjects with poor response and/or who do not respond to the conventional therapies, that means subjects who are still at risk of relapse or exacerbation after conventional therapies with hormones, immunosuppressants (e.g., azathioprine, mycophenolate mofetil, tacrolimus, cyclosporin A, cyclophosphamide, methotrexate, etc.), or biological agents (e.g., rituximab);
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- For patients who are taking corticosteroids, the dose of prednisone should not exceed 30 mg/day (or an equivalent dose of other corticosteroids), and the dose must be stable for at least 4 weeks before infusion;
- The laboratory test results during the screening period meet the following criteria:
- Neutrophil count ≥ 1.0×10^9/L; Hemoglobin ≥ 8.0 g/dL; Platelet count≥50×10^9/L;
- Alanine aminotransferase ≤ 3× upper limit of normal (ULN); Aspartate aminotransferase ≤ 3×ULN; total bilirubin (TBIL) < 2× ULN (for subjects with Gilbert's syndrome), direct bilirubin (DBIL)) ≤ 1.5×ULN
- Creatinine clearance (19.3 Appendix 3) ≥ 30 mL/min;
- Activated partial thromboplastin time (APTT) ≤ 1.5×ULN, prothrombin time (PT)≤ 1.5×ULN;
- Subject's left ventricular ejection fraction (LVEF) is ≥ 50% by echocardiography, with no evidence of pericardial effusion as determined;
- Female subjects of child-bearing age must:
- At screening, a negative serum β human chorionic gonadotropin β-hCG pregnancy test result confirmed by the investigator;
- Who agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later).
- Male subjects with sexual partners and female subjects of potential child-bearing age shall agree to take effective contraceptive measures (e.g., oral contraceptive pills, intrauterine device or condom) from the screening period until at least 2 years after the infusion of GC012F Injection or until two consecutive flow cytometry tests show the absence of CAR-T cells (whichever occurs later). Male subjects must agree to use condoms during sexual contact with pregnant women or females of child-bearing age within at least 2 years after the infusion of GC012F Injection, even if a successful vasectomy has been performed;
- Subjects for whom venous access available for blood collection can be established, and with no contraindications to leukocyte collection.
Who cannot join
- Participants who meet any of the following criteria are not included in the study:
- Have a history of severe hypersensitivity or allergy;
- Contraindications or hypersensitivity to fludarabine, cyclophosphamide and any component of the test drug;
- Subjects who have received intravenous immunoglobulin or plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to infusion;
- Received CD20-targeted drugs within 6 months prior to apheresis;
- Received Tacrolimus, Cyclosporine, Azathioprine, Mycophenol Mofetil within 1 week before apheresis;
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- Treatment with neonatal Fc receptor (FcRn) antagonists within 1 week prior to apheresis;
- Patients who have received complement inhibitors (e.g., eculizumab, etc.) within 1 weeks before apheresis ;
- Subjects with any of the following heart diseases:
- Class III or Class IV congestive heart failure based on New York Heart Association (NYHA) Functional Classification;
- Unstable angina, myocardial infarction or coronary artery bypass grafting (CABG) within 6 months prior to screening;
- Clinically significant ventricular arrhythmia or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval >480 ms at screening;
- Has a history of severe non-ischemic cardiomyopathy;
- Severe cardiovascular abnormalities (such as brain natriuretic peptide (BNP)/troponin and other indices) and the investigator judges that such subjects are not eligible for enrollment.
- Subjects with other uncontrolled malignancies. The following conditions will be excluded: early-stage tumors that have been treated by radical surgery (carcinoma in situ or grade 1 tumors, or non-ulcerative primary melanoma with a depth of <1 mm and with no involvement of lymph nodes), basal cell carcinoma, cutaneous squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has been treated by potential radical treatment;
- Serious underlying medical conditions, such as:
- Viral, bacterial, fungal, or other infections that are uncontrollable or requiring systemic intravenous therapy (including tuberculosis infection with clear evidence of disease activity) as demonstrated by evidence;
- Dementia or mental status changes as demonstrated by significant clinical evidence;
- History of any central nervous system (CNS) or neurodegenerative diseases, (e.g., Epilepsy, Convulsion, Paralysis, Aphasia, Stroke, Severe brain injury, Dementia, Parkinson's disease, Mental Illness).
- Positive result for any of the following tests:
- Positive test result of human immunodeficiency virus (HIV) antibody;
- Positive test result of hepatitis B surface antigen (HBsAg) or hepatitis B core antibody (HBcAb) (HBV DNA copy number will be detected for HBcAb- or HBsAb-positive patients. If the copy number is lower than the lower limit of detection, patients can be enrolled under the premise of standardized antiviral therapy);
- Positive test result of hepatitis C virus (HCV) antibody with the copy number of HCV RNA higher than the lower limit of detection; or with known history of hepatitis C without completion of antiviral therapy for ≥24 weeks;
- Positive test result of Syphilis antibody.
- Prior treatment with a CAR-T product for any target;
- Previous organ or allogeneic bone marrow transplantation;
- Subjects who have undergone surgery within 2 weeks prior to lymphodepletion pretreatment or plan to undergo surgery during the study (except subjects who schedule for local anesthesia surgery, but the surgery cannot be performed within 2 weeks after infusion);
- Received live attenuated vaccine within 4 weeks prior to lymphodepletion pretreatment;
- Subjects who have received study drugs in other clinical trials within 4 weeks prior to signing the informed consent form, or whose ICF signing date is within 5 half-lives of the last dose they had taken in other clinical trial (whichever is longer);
- Pregnant females or lactating females who do not agree to give up breastfeeding, during the period of participation in this study or men with a family plan within 1 year of receiving study treatment and females;
- Subjects with suicidal intentions at present based on the Columbia-Suicide Severity Rating Scale (C-SSRS), i.e., the answer to Question 4 (Active Suicidal Ideation with Some Intent to Act, without Specific Plan) or Question 5 (Active Suicidal Ideation with Specific Plan and Intent) on "Suicide" in the C-SSRS is "Yes", or who have a history of suicidal behavior at present;
- According to the researcher's judgment, there are circumstances that may prevent the subject from participating in the full trial, confuse the trial results, or participation in this study is not in the best interests of subjects.
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 of Tongji Medical Colledge, Huazhong University of Science and Technology
Wuhan, Hubei, 430000
Dai-shi Tian, Dr
About this study
Official title: An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
This is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.
Read the detailed description
This study is a single-arm, open-label, early-stage exploratory clinical study designed to evaluate safety, tolerability and preliminary efficacy of GC012F injection in the treatment of subjects with refractory GMG,the PK, PD characteristics and immunogenicity of GC012F injection in subjects were evaluated.
This trial is divided into:screening period, apheresis day, baseline period, lymphodepletion pretreatment period, infusion day, safety and efficacy follow-up period, long-term follow-up period and withdrawal visits.Eligible subjects will undergo apheresis collection and then receive the CAR-T infusion after the manufacturing of the products. Subjects in the lymphodepletion cohort will receive the conditioning regimen and then receive CAR-T cell infusion (per the schedule of assessment). Subjects who meet the cell infusion criteria will receive CAR-T cell infusion at the doses levels which were specified in the protocol, and the dose levels could be adjusted according to safety and clinical efficacy.
In this study, the infusion dose of CAR-T cells was set up in one dose group: 3×10^5/kg. About 6 participants are planned to be included. The subjects will be monitored for DLT for 28 days after the infusion of GC012F injection. For the first 3 patients to receive GC012F infusion, if ≤1/3 of the patients develop a DLT at a given dose level, the additional 3 patients will be enrolled in this cohort. If 2/3 or more DLTs occur at this dose level, subsequent subjects may be given a backup dose group of 2.0×10^5/kg or 1.0×10^5/kg after discussion between the investigator and the collaborator.
In the completion dose group of all subjects ,after the DLT observation period, DLTs will be observed for this dose group , all clinical study data collected during the period, especially safety data, were evaluated by the investigator discuss with the collaborator whether to add new subjects to the dose group or explore higher doses group.
After CAR-T cell infusion, subjects will be followed up for safety, cell proliferation, survival, and efficacy until the subject progresses on the disease, or withdraws from the study and refuses to accept follow-up , or dies, or withdraws informed consent, or is lost to follow-up (whichever occurs first).
- Conditions
- Generalized Myasthenia Gravis (gMG)
- Being tested
- GC012F injection
- Medical subject headings
- Myasthenia Gravis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionDrug
Subjects will be infused with GC012F Injection within 48-72 hours after lymphodepletion pretreatment,the infusion doses will be (CAR-T cell count) 3 × 10^5/kg.
Note: for subjects weighing ≤70 kg: number of infused CAR-T cells = 3 (±20%) × 10^5 × body weight(kg); for subjects weighing >70 kg: number of infused CART cells (fixed doses of GC012F Injection) = 3 (±20%) × 10^5 × 70 kg.
| Study group | Role | What they receive |
|---|---|---|
| 3×10^5/kg | Experimental | In this study, the infusion dose of CAR-T cells was set up in one dose group: 3×10^5/kg. About 6 participants are planned to be included. The subjects will be monitored for DLT for 28 days after the infusion of GC012F injection. For the first 3 patients to receive GC012F infusion, if ≤1/3 of the patients develop a DLT at a given dose level, the additional 3 patients will be enrolled in this cohort. If 2/3 or more DLTs occur at this dose level, subsequent subjects may be given a backup dose group of 2.0×10^5/kg or 1.0×10^5/kg after discussion between the investigator and the collaborator. Receives: Drug: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of adverse events.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Secondary outcomes (10)
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- Cmax(based on data availability).
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- Tmax(based on data availability).
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- AUC(based on data availability).
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
T/B lymphocyte subsets in peripheral blood after GC012F infusion.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Levels of cytokines in peripheral blood after GC012F infusion.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Proportion of patients with improvement in MG-Activities of Daily Living (MG-ADL) score and quantitative muscle weakness (QMG) score and MG-ADL and QMG score with different improvement scores from baseline to 24 weeks after GC012F infusion.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Proportion of patients with MG composite score (MGC) improvement and MGC score improvement scores from baseline to 24 weeks after infusion and reinfusion of GC012F.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Mean change in patient-reported outcome scores such as MG-QoL15r score from baseline to 24 weeks after infusion and return infusion of GC012F.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Change in the patient's status after MGFA intervention 24 weeks after the infusion of GC012F.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Reduction in pathogenic antibody levels and proportion of patients in a cohort of MG-specific autoantibody-positive patients from baseline to 24 weeks after GC012F infusion and reinfusion.
Measured: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2025
- Study start15 Jul 2025
- Primary completion13 Feb 2027 (estimated)
- Study completion10 Sep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Generalized Myasthenia Gravis (gMG)Studies of the same condition, open and under way.
- 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
- None (Open Label)
- Masking
- None (open label)
- Enrolment
- 6 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Daishi Tian
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Responsible party
- Sponsor-investigator, Daishi Tian, Tongji Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07058298
- Sponsor's protocol ID
- GC012FinGMG
- Status last verified
- Sep 2025
- First submitted
- 7 Jun 2025
- Last updated
- 8 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- 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 8 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Early Exploratory Clinical Study of GC012F Injection in the Treatment of Refractory Generalized Myasthenia Gravis
- ClinicalTrials.gov ID
- NCT07058298
- Acronym / sponsor ID
- GC012FinGMG
- Conditions
- Generalized Myasthenia Gravis (gMG)
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 6 participants (estimated)
- Lead sponsor
- Daishi TianUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 15 Jul 2025 (actual)
- Primary completion
- 13 Feb 2027 (estimated)
- Study completion
- 10 Sep 2027 (estimated)
- First posted
- 10 Jul 2025 (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 is a single-arm, open-label and early exploratory clinical study, with the purpose to study the safety, tolerability and initial clinical efficacy of GC012F Injection in the treatment of refractory GMG and to evaluate the PK, PD characteristics and immunogenicity in subjects with refractory GMG infused with GC012F Injection.
Detailed description
This study is a single-arm, open-label, early-stage exploratory clinical study designed to evaluate safety, tolerability and preliminary efficacy of GC012F injection in the treatment of subjects with refractory GMG,the PK, PD characteristics and immunogenicity of GC012F injection in subjects were evaluated.
This trial is divided into:screening period, apheresis day, baseline period, lymphodepletion pretreatment period, infusion day, safety and efficacy follow-up period, long-term follow-up period and withdrawal visits.Eligible subjects will undergo apheresis collection and then receive the CAR-T infusion after the manufacturing of the products. Subjects in the lymphodepletion cohort will receive the conditioning regimen and then receive CAR-T cell infusion (per the schedule of assessment). Subjects who meet the cell infusion criteria will receive CAR-T cell infusion at the doses levels which were specified in the protocol, and the dose levels could be adjusted according to safety and clinical efficacy.
In this study, the infusion dose of CAR-T cells was set up in one dose group: 3×10^5/kg. About 6 participants are planned to be included. The subjects will be monitored for DLT for 28 days after the infusion of GC012F injection. For the first 3 patients to receive GC012F infusion, if ≤1/3 of the patients develop a DLT at a given dose level, the additional 3 patients will be enrolled in this cohort. If 2/3 or more DLTs occur at this dose level, subsequent subjects may be given a backup dose group of 2.0×10^5/kg or 1.0×10^5/kg after discussion between the investigator and the collaborator.
In the completion dose group of all subjects ,after the DLT observation period, DLTs will be observed for this dose group , all clinical study data collected during the period, especially safety data, were evaluated by the investigator discuss with the collaborator whether to add new subjects to the dose group or explore higher doses group.
After CAR-T cell infusion, subjects will be followed up for safety, cell proliferation, survival, and efficacy until the subject progresses on the disease, or withdraws from the study and refuses to accept follow-up , or dies, or withdraws informed consent, or is lost to follow-up (whichever occurs first).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- None (Open Label)
| Arm | Type | Receives |
|---|---|---|
| 3×10^5/kg | Experimental | Drug: GC012F injectionIn this study, the infusion dose of CAR-T cells was set up in one dose group: 3×10^5/kg. About 6 participants are planned to be included. The subjects will be monitored for DLT for 28 days after the infusion of GC012F injection. For the first 3 patients to receive GC012F infusion, if ≤1/3 of the patients develop a DLT at a given dose level, the additional 3 patients will be enrolled in this cohort. If 2/3 or more DLTs occur at this dose level, subsequent subjects may be given a backup dose group of 2.0×10^5/kg or 1.0×10^5/kg after discussion between the investigator and the collaborator. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (18 listed)
- To be enrolled, subjects must meet all of the following criteria:
Key exclusion criteria (32 listed)
- Participants who meet any of the following criteria are not included in the study:
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 |
|---|---|---|
| GC012F injectionSubjects will be infused with GC012F Injection within 48-72 hours after lymphodepletion pretreatment,the infusion doses will be (CAR-T cell count) 3 × 10^5/kg. Note: for subjects weighing ≤70 kg: number of infused CAR-T cells = 3 (±20%) × 10^5 × body weight(kg); for subjects weighing >70 kg: number of infused CART cells (fixed doses of GC012F Injection) = 3 (±20%) × 10^5 × 70 kg. | Drug | 3×10^5/kg |
Primary outcome
The frequency and severity of adverse events.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
10 secondary outcomes
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- Cmax(based on data availability).
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- Tmax(based on data availability).
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Analysis of cell dynamics (CK) parameters of the copy number of the GC012F CAR gene in peripheral blood- AUC(based on data availability).
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
T/B lymphocyte subsets in peripheral blood after GC012F infusion.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Levels of cytokines in peripheral blood after GC012F infusion.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Proportion of patients with improvement in MG-Activities of Daily Living (MG-ADL) score and quantitative muscle weakness (QMG) score and MG-ADL and QMG score with different improvement scores from baseline to 24 weeks after GC012F infusion.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Proportion of patients with MG composite score (MGC) improvement and MGC score improvement scores from baseline to 24 weeks after infusion and reinfusion of GC012F.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Mean change in patient-reported outcome scores such as MG-QoL15r score from baseline to 24 weeks after infusion and return infusion of GC012F.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Change in the patient's status after MGFA intervention 24 weeks after the infusion of GC012F.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
Reduction in pathogenic antibody levels and proportion of patients in a cohort of MG-specific autoantibody-positive patients from baseline to 24 weeks after GC012F infusion and reinfusion.
Time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.
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 8 Sep 2025.
- 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.
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 GC012F injection in people with Generalized Myasthenia Gravis (gMG), run by Daishi Tian 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 18 inclusion and 32 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 8 Sep 2025. 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 Chuan Qin Sub-I (13886052650, chuanqin@tjh.tjmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The frequency and severity of adverse events. (time frame: Since signing the ICF until 24-week post-infusion or withdrawal from the study, whichever comes first.). 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 8 Sep 2025.