Autoimmune DiseasesEarly Phase 1NCT07122076
GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
A Early Phase 1 study testing GT719 Injection in people with Autoimmune Diseases, run by Grit Biotechnology at 1 site in China.
Trial summary
This study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Autoimmune Diseases
- What is being tested?
- GT719 Injection
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteChina
- Study dates
- 22 Aug 2025to 21 Aug 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- Aged 18 to 65 years (inclusive), regardless of gender.
- The functions of important organs meet the following requirements，excluding those attributable to disease activity:
- Bone marrow hematopoietic function needs to meet: Neutrophil count ≥1×10^9/L; Hemoglobin ≥80g/L; Platelets ≥30×10^9/L;
- Liver function: ALT≤3×ULN; AST≤3×ULN; TBIL≤1.5×ULN;
- Renal function: creatinine clearance (CrCl) ≥30 ml/minute;
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- Coagulation function: International standardized ratio (INR) ≤1.5×ULN, prothrombin time (PT) ≤1.5×ULN;
- Heart function: good hemodynamic stability, with no evidence of moderate or greater pericardial effusion.
- Women of childbearing age must:
- During screening, the test result for serum β-human chorionic gonadotropin (β-hCG) was negative;
- Agree to avoid breastfeeding during the study period until at least one year after the infusion of GT719 cell injection or until two consecutive flow cytometry tests show the absence of GT719 cells (whichever occurs later);
- Male participants with sexual partners and female participants with potential fertility agree to use highly effective contraceptive methods from screening until at least one year after GT719 cell injection or until two consecutive flow cytometry tests show the absence of GT719 cells (whichever occurs later). Male participants must agree to use condoms during sexual contact with pregnant or fertile women for at least one year after infusion of GT719 cell injection, even after successful vasectomy.
- Specific inclusion criteria:
- Systemic lupus erythematosus
- Complies with the classification standards of the 2019 European Union Against Rheumatology/American Society of Rheumatology (EULAR/ACR) SLE;
- Disease activity score SELENA SLEDAI≥6 with at least one Injima Lupus Assessment Group Index (BILAG-2004) category A (severe presentation) or two Category B (moderate presentation) organ scores, or both; Or disease activity score SELENA SLEDAI score ≥8;
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept.
- Inflammatory myopathy
- Inflammatory myopathy fulfilling the 2017 EULAR/ACR classification criteria (including Dermatomyositis (DM), Polymyositis (PM), Anti-Synthetase Syndrome (ASS), and Necrotizing Myopathy (NM)).
- Positive myositis antibodies;
- Muscle involvement with Manual Muscle Testing-8 (MMT-8) score less than 142 and at least two abnormalities found among the following five core measurements (Physician Global Assessment (PhGA), Patient Global Assessment (PtGA), or extramuscular disease activity score ≥ 2; Health Assessment Questionnaire (HAQ) total score ≥ 0.25; muscle enzyme levels ≥ 1.5×ULN; or MMT-8 ≥ 142, but with active interstitial lung disease (HRCT showing ground-glass opacities);
- Definition of relapsed/refractory: Conventional treatment over 6 months remains ineffective, or disease recurrence after remission. Definition of conventional treatment: the use of glucocorticoids and cyclophosphamide, and any one or more of the following immunomodulatory drugs: antimalarials, azathioprine, mycophenolate mofetil, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including belimumab, rituximab, and tocilizumab, etc.
- Definition of progressive: Rapid progression of interstitial lung disease within a short period.
- Note: Meeting either criterion 4 or 5 is sufficient.
- Diffuse systemic sclerosis
- Meet the 2013 ACR classification criteria for systemic sclerosis;
- Positive antibodies related to systemic sclerosis;
- Definition of relapse refractory: conventional treatment remains ineffective for more than 6 months or disease activity occurs again after remission. Conventional treatment is defined as the use of glucocorticoids and cyclophosphamide, and any of the following immunomodulators: antimalarials, azathioprine, mortemycophanate, methotrexate, leflunomide, tacrolimus, cyclosporine, and biologics including rituximab, belimumab and telitacicept
- Definition of progression: rapid skin progression (mRSS increase >25%); Or progression of lung disease (a 10% reduction in FVC, or a more than 5% reduction in FVC with a 15% reduction in DLCO).
- Note: Articles 4 and 5 satisfy one or the other.
Who cannot join
- SLE participants:
- Drug induced SLE;
- Patients with lupus crisis or concomitant diseases who require the use of contraindicated drugs according to the protocol are deemed unsuitable for inclusion by the investigator.
- IIM participants
- Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor associated PM or DM, non-inflammatory myopathy (such as muscular dystrophy);
- Uncontrolled extramuscular disease damage related to PM or DM:
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- ILD: FVC<55% or requiring oxygen therapy;
- Severe swallowing difficulties, as determined by investigator, increase the risk of patients participating in clinical trials;
- Severe cardiac manifestations (such as congestive heart failure, arrhythmia, conduction abnormalities requiring treatment, or myocardial infarction) have been determined by investigator to increase the risk of patients participating in clinical trials.
- SSc participants
- Moderate to severe pulmonary arterial hypertension (PAH) associated with SSc that cannot be controlled by drug therapy;
- Rapid progressive SSc related low gastrointestinal (small and large intestine) involvement (requiring parenteral nutrition); Active dilation of gastric antral blood vessels;
- Uncontrolled or rapidly progressing ILD with oxygen saturation (SaO2) <92% (in still indoor air); Or require mechanical respiratory assistance (ventilator) within one year prior to signing the informed consent form.
- Has a history of severe hypersensitivity reactions or allergies;
- Contraindications or hypersensitivity reactions to any components of fludarabine, cyclophosphamide, and experimental drugs;
- Suffering from the following heart diseases:
- NYHA Grade III or IV congestive heart failure;
- Has experienced a myocardial infarction or undergone coronary artery bypass surgery within the 6 months prior to the screening period;
- A clinically significant history of ventricular arrhythmia or unexplained syncope, not caused by vasovagal nerve response or dehydration, or a corrected QT interval (QTc)>480 ms during screening;
- History of severe non ischemic cardiomyopathy;
- Any active malignant tumors or history of malignant tumors within the past 5 years before screening. Excluding the following situations: early-stage tumors that have received curative treatment (in situ or stage I tumors, non ulcerative primary melanoma with a depth of<1 mm and no involvement of lymph nodes), basal cell carcinoma of the skin, squamous cell carcinoma of the skin, cervical in situ cancer, or breast in situ cancer that has received potential curative treatment;
- Individuals with clinically significant bleeding symptoms or clear bleeding tendencies within the 6 months prior to screening, such as gastrointestinal bleeding, hemorrhagic gastric ulcers, etc; Hereditary or acquired bleeding and thrombophilia tendencies (such as hemophilia, coagulation dysfunction, splenic hyperfunction, etc.); Occurrence of arteriovenous thrombosis events within 6 months prior to screening, such as cerebrovascular disease (including cerebral hemorrhage, cerebral infarction, etc.), deep vein thrombosis, and/or pulmonary embolism;
- When screening, there may be serious underlying medical conditions, such as:
- There is evidence to suggest the presence of uncontrollable viruses, bacteria, fungi, or other infections that require systemic intravenous treatment;
- There is clear clinical evidence indicating the presence of dementia or changes in mental state;
- Any other history of central nervous system disorders or neurodegenerative diseases, such as epilepsy, seizures, paralysis, aphasia, stroke, severe brain injury, dementia, Parkinson's disease, mental illness;
- Any of the following test results is positive:
- Positive for human immunodeficiency virus (HIV) antibodies;
- Hepatitis B surface antigen (HBsAg) positive; Or if the hepatitis B core antibody (HBcAb) is positive and the hepatitis B virus (HBV) - DNA is higher than the detection limit of the analytical method;
- Hepatitis C virus (HCV) antibody positive and HCV RNA above the detection limit of the analytical method;
- Syphilis antibody positive (false positive result due to reasons other than the disease);
- Cytomegalovirus (CMV) (DNA) and Epstein Barr virus (EBV) (DNA) tests positive;
- Active tuberculosis or latent tuberculosis without proper treatment before screening;
- Received other clinical trial drugs within 4 weeks prior to the signing of the informed consent form (ICF), or the ICF signing date is within 5 half lives of the drug from the last use of the drug in the previous clinical trial (whichever is longer);
- Received plasma exchange therapy or immunoadsorption therapy within 4 weeks prior to lymphodepleting chemotherapy;
- Used drugs targeting B cells, including but not limited to rituximab, belimumab, tacrolizumab, etc., within one week before lymphodepleting chemotherapy;
- Used tacrolimus, cyclosporine, azathioprine, mycophenolate mofetil, mycophenolate mofetil, methotrexate, etc. within 2 weeks before lymphodepleting chemotherapy;
- Used neonatal Fc receptor (FcRn) antagonist therapy (such as Efgartigimod) within 3 weeks before lymphodepleting chemotherapy;
- Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;
- Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;
- Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;
- Medical history of organ transplantation;
- Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);
- According to the investigator's judgment, the situations that hinder participants from participating in the entire trial, confound the trial results, or participate in the trial that are not in the best interests of the participants.
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
Shanghai Changzheng Hospital
Shanghai
Huji Xu, 86021-81885514, xuhuji@smmu.edu.cn
Huji Xu
About this study
Official title: A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
This study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study.
- Conditions
- Autoimmune Diseases
- Being tested
- GT719 Injection
- Medical subject headings
- Autoimmune Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GT719 InjectionBiological
GT719 Injection
| Study group | Role | What they receive |
|---|---|---|
| GT719 Injection treatment group | Experimental | GT719 Injection Receives: Biological: GT719 Injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of participants experiencing dose limiting toxicity
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Measured: 28 days
Incidence of treatment-emergent adverse events
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards
Measured: 3 months
Secondary outcomes (3)
Efficacy outcomes for SLE
SLE Response index 4(SR-4) response: Min/Max Value: Not specified; a decrease in score indicates improvment, higher scores indicate worse outcome
Measured: 14 days,1, 2, 3 and 6 Months post GT719 infusion
Efficacy outcomes for Systemic Sclerosis
ACR-CRISS score (CRISS score≥0.6 improvment, <0.6 no improvement)
Measured: 14 days,1, 2, 3 and 6 Months post GT719 infusion
Efficacy outcomes for Inflammatory Myopathy
Total lmprovement Score (TlS): Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome.
Measured: 14 days,1, 2, 3 and 6 Months post GT719 infusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2025
- Study start22 Aug 2025
- Primary completion21 Aug 2028 (estimated)
- Study completion21 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Autoimmune DiseasesStudies of the same condition, open and under way.
- More trials run by Grit BiotechnologyThe 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
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07122076
- Sponsor's protocol ID
- GRIT-CD-CHN-719-003-030
- Status last verified
- Sep 2026
- First submitted
- 29 Jul 2025
- Last updated
- 18 Sep 2026
- Results posted
- 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 18 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases
- ClinicalTrials.gov ID
- NCT07122076
- Acronym / sponsor ID
- GRIT-CD-CHN-719-003-030
- Conditions
- Autoimmune Diseases
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- 22 Aug 2025 (actual)
- Primary completion
- 21 Aug 2028 (estimated)
- Study completion
- 21 Aug 2028 (estimated)
- First posted
- 14 Aug 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 study is a prospective single-arm open-label clinical trial, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune diseases. A total of 10 subjects will be enrolled in this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GT719 Injection treatment group | Experimental | Biological: GT719 InjectionGT719 Injection |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (30 listed)
- Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- Aged 18 to 65 years (inclusive), regardless of gender.
- The functions of important organs meet the following requirements，excluding those attributable to disease activity:
- Women of childbearing age must:
- Systemic lupus erythematosus
Key exclusion criteria (44 listed)
- SLE participants:
- IIM participants
- ILD: FVC<55% or requiring oxygen therapy;
- Severe swallowing difficulties, as determined by investigator, increase the risk of patients participating in clinical trials;
- Severe cardiac manifestations (such as congestive heart failure, arrhythmia, conduction abnormalities requiring treatment, or myocardial infarction) have been determined by investigator to increase the risk of patients participating in clinical trials.
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 |
|---|---|---|
| GT719 InjectionGT719 Injection | Biological | GT719 Injection treatment group |
Primary outcome
Proportion of participants experiencing dose limiting toxicity
Time frame: 28 days
Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence of treatment-emergent adverse events
Time frame: 3 months
Safety assessments are conducted using the NCI-CTCAE version 5.0 standards
3 secondary outcomes
Efficacy outcomes for SLE
Time frame: 14 days,1, 2, 3 and 6 Months post GT719 infusion
Efficacy outcomes for Systemic Sclerosis
Time frame: 14 days,1, 2, 3 and 6 Months post GT719 infusion
Efficacy outcomes for Inflammatory Myopathy
Time frame: 14 days,1, 2, 3 and 6 Months post GT719 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 18 Sep 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.
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 GT719 Injection in people with Autoimmune Diseases, run by Grit Biotechnology 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 30 inclusion and 44 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 18 Sep 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 Huji Xu (+86-21-81885514, xuhuji@smmu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of participants experiencing dose limiting toxicity (time frame: 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 18 Sep 2026.