GT719 Injection for Moderate to Severe Refractory Autoimmune Disease

Not Applicable

Not yet recruiting

• Conditions: Auto Immune Disease
• Interventions: Biological: GT719 Injection

• Registration Number: NCT07132112
• Lead Sponsor: Grit Biotechnology

Brief 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. A total of 30 subjects will be enrolled in this study.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-08
• Study Start: 2025-08-01
• Study First Submitted: 2025-08-14
• Study First Submitted QC: 2025-08-14
• Last Update Submitted: 2025-08-14
• Study First Posted: 2025-08-20
• Last Update Posted: 2025-08-20
• Primary Completion: 2028-08
• Study Completion: 2028-08-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• 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)

  4. Meets the classification criteria for SLE in the 2019 European League Against Rheumatism/American College of Rheumatology (EULAR/ACR);

  5. 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;

• 4. Participants with idiopathic inflammatory myopathy （IIM）

  5. Complies with the 2017 EULAR/ACR classification criteria for inflammatory myopathy (including DM, PM, ASS, and NM)

  6. Myositis antibody positive;

  7. . Meets the definition of recurrence, refractory or progressive;

• 5. Participants with systemic sclerosis

  6. . Meet the 2013 American College of Rheumatology (ACR) SSc criteria;

  7. . SSc related antibodies are positive;

  8. . Meets the definition of refractory or progressive recurrence

Exclusion Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
GT719 Injection treatment group	GT719 Injection	GT719 Injection

Primary Outcome Measures

Name	Time	Method
Proportion of participants experiencing dose limiting toxicity	28 days	Proportion of participants experiencing dose limiting toxicity (DLT) within 28 days after cell infusion
Incidence of treatment-emergent adverse events	2 years	Safety assessments are conducted using the NCI-CTCAE version 5.0 standards

Secondary Outcome Measures

Name	Time	Method
Efficacy outcomes for SLE	14 days; 1, 2, 3 and 6 Months post GT719 infusion	SLE response index 4 (SR-4) response
Efficacy outcomes for Systemic Sclerosis	14 days; 1, 2, 3, and 6 months post GT719 infusion	ACR-CRISS score (CRISS score≥0.6 improvment, \<0.6 no improvment)
Efficacy outcomes for Inflammatory Myopathy	14 days; 1, 2, 3, and 6 months post GT719 infusion	Total Improvement Score (TIS)

Trial Locations

Locations (1)

Affiliated Hospital of Nantong University; 🇨🇳 Nantong, Jiangsu, China