NCT07132112

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at P50-P75 for early_phase_1

Timeline
28mo left

Started Oct 2025

Typical duration for early_phase_1

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress19%
Oct 2025Aug 2028

First Submitted

Initial submission to the registry

August 14, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

August 20, 2025

Completed
2 months until next milestone

Study Start

First participant enrolled

October 28, 2025

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2028

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2028

Last Updated

April 16, 2026

Status Verified

April 1, 2026

Enrollment Period

2.8 years

First QC Date

August 14, 2025

Last Update Submit

April 13, 2026

Conditions

Auto Immune Disease

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

    2 years

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

Study Arms (1)

GT719 Injection treatment group

EXPERIMENTAL

GT719 Injection

Biological: GT719 Injection

Interventions

GT719 InjectionBIOLOGICAL

GT719 Injection

GT719 Injection treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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.
  • \. 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;
  • \. 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;
  • \. 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

You may not qualify if:

  • \. 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

RECRUITING

Central Study Contacts

Zhifeng Gu

CONTACT

086-13706291941guzhifeng@126.com

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

August 14, 2025

First Posted

August 20, 2025

Study Start

October 28, 2025

Primary Completion (Estimated)

August 1, 2028

Study Completion (Estimated)

August 1, 2028

Last Updated

April 16, 2026

Record last verified: 2026-04

Data Sharing

IPD Sharing
Will not share

Locations

CN(1)