Auto Immune DiseaseEarly Phase 1NCT07132112
GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
A Early Phase 1 study testing GT719 Injection in people with Auto Immune Disease, run by Grit Biotechnology at 1 site in China.
Trial summary
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Auto Immune Disease
- 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
- 30 participants
- Where
- 1 siteChina
- Study dates
- 28 Oct 2025to 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
- 1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- 2. Aged 18 to 65 years (inclusive), regardless of gender.
- Specific inclusion criteria:
- 3. Participants with systemic lupus erythematosus (SLE)
- Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);
- Disease activity score SLEDAI-2000 ≥ 6, with at least one British Islet Lupus Assessment Group Index (BILAG-2004) Grade A (severe manifestations) or two Grade B (moderate manifestations) organ scores, or both; Or the disease activity score SLEDAI-2000 ≥ 8;
Show all 14Show fewer
- 4. Participants with idiopathic inflammatory myopathy （IIM）
- Complies with the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM)
- Myositis antibody positive;
- . Meets the definition of recurrence, refractory or progressive;
- 5. Participants with systemic sclerosis
- . Meet the 2013 American College of Rheumatology (ACR) SSc criteria;
- . SSc related antibodies are positive;
- . Meets the definition of refractory or progressive recurrence
Who cannot join
- 1. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;
- 2. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;
- 3. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;
- 4. Medical history of organ transplantation;
- 5. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);
- 6. 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
Affiliated Hospital of Nantong University
Nantong, Jiangsu
Zhifeng Gu, 086-13706291941, guzhifeng@126.com
Zhifeng Gu
About this study
Official title: A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease
This study is a prospective single-arm open-label clinical trial, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 subjects will be enrolled in this study.
- Conditions
- Auto Immune Disease
- Being tested
- GT719 Injection
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: 2 years
Secondary outcomes (3)
Efficacy outcomes for SLE
SLE response index 4 (SR-4) response
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 improvment)
Measured: 14 days; 1, 2, 3, and 6 months post GT719 infusion
Efficacy outcomes for Inflammatory Myopathy
Total Improvement Score (TIS)
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 posted20 Aug 2025
- Study start28 Oct 2025
- Primary completionAug 2028 (estimated)
- Study completionAug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Auto Immune DiseaseStudies 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
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Grit Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Nantong University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07132112
- Sponsor's protocol ID
- GRIT-CD-CHN-719-003-058
- Status last verified
- Apr 2026
- First submitted
- 14 Aug 2025
- Last updated
- 16 Apr 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 16 Apr 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 Disease
- ClinicalTrials.gov ID
- NCT07132112
- Acronym / sponsor ID
- GRIT-CD-CHN-719-003-058
- Conditions
- Auto Immune Disease
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Grit BiotechnologyIndustry (pharma, biotech, devices)
- Collaborators
- Affiliated Hospital of Nantong University
- Study start
- 28 Oct 2025 (actual)
- Primary completion
- Aug 2028 (estimated)
- Study completion
- Aug 2028 (estimated)
- First posted
- 20 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, including dose escalation and expansion phase, aims to evaluate the safety, efficacy, and cellular pharmacokinetics of GT719 Injection in patients with moderate to severe refractory autoimmune disease. A total of 30 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 (14 listed)
- 1. Voluntarily enrolled in the study, signed an informed consent form, willing and able to comply with the study protocol.
- 2. Aged 18 to 65 years (inclusive), regardless of gender.
- 3. Participants with systemic lupus erythematosus (SLE)
- 4. Participants with idiopathic inflammatory myopathy （IIM）
- 5. Participants with systemic sclerosis
Key exclusion criteria (6 listed)
- 1. Within 3 weeks prior to lymphodepleting chemotherapy, complement inhibition therapy (such as Ecuzumab) has been used;
- 2. Received attenuated live vaccine within 4 weeks before lymphodepleting chemotherapy;
- 3. Having undergone major surgery within the 8 weeks prior to screening, or planning to undergo surgery during the study period;
- 4. Medical history of organ transplantation;
- 5. Previously received CAR-T product therapy targeting any target (excluding GT719 therapy);
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: 2 years
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 16 Apr 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 Auto Immune Disease, 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 14 inclusion and 6 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 16 Apr 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 Zhifeng Gu (086-13706291941, guzhifeng@126.com), 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 16 Apr 2026.