GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases

NCT07122076 | Recruiting Early Phase 1

• 1 other identifier: GRIT-CD-CHN-719-003-030
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Autoimmune Diseases

Outcome Measures

Primary Outcomes (2)

• Proportion of participants experiencing dose limiting toxicity

  Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion

  28 days

• Incidence of treatment-emergent adverse events

  Safety assessments are conducted using the NCI-CTCAE version 5.0 standards

  3 months

Secondary Outcomes (3)

• Efficacy outcomes for SLE

  14 days,1, 2, 3 and 6 Months post GT719 infusion

• Efficacy outcomes for Systemic Sclerosis

  14 days,1, 2, 3 and 6 Months post GT719 infusion

• Efficacy outcomes for Inflammatory Myopathy

  14 days,1, 2, 3 and 6 Months post GT719 infusion

Other Outcomes (3)

• Efficacy outcomes for SLE

  12 weeks

• Efficacy outcomes for Systemic Sclerosis

  12 weeks

• Efficacy outcomes for Inflammatory Myopathy

  12 weeks

Study Arms (1)

GT719 Injection treatment group

EXPERIMENTAL

GT719 Injection

Biological: GT719 Injection

Interventions

GT719 Injection BIOLOGICAL

GT719 Injection

GT719 Injection treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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.
• 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;

You may not qualify if:

• SLE participants:
• Drug induced SLE;
• IIM participants
• Uncontrolled extramuscular disease damage related to PM or DM:
• 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;

Sponsors & Collaborators

• Grit Biotechnology: lead

Study Sites (1)

Shanghai Changzheng Hospital

Shanghai, China

RECRUITING

MeSH Terms

Conditions

Autoimmune Diseases

Condition Hierarchy (Ancestors)

Immune System Diseases

Central Study Contacts

Huji Xu

CONTACT

+86-21-81885514; xuhuji@smmu.edu.cn

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 29, 2025
• First Posted: August 14, 2025
• Study Start: August 22, 2025
• Primary Completion (Estimated): August 21, 2028
• Study Completion (Estimated): August 21, 2028
• Last Updated: September 22, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)