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NCT Number: NCT07132112

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.

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Key information

Conditions

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Affiliated Hospital of Nantong University

Nantong, Jiangsu, China

Location status: Recruiting

Location contact

Zhifeng Gu

CONTACT

[email protected]

086-13706291941

Zhifeng Gu

PRINCIPAL_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)
  • 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;
  • 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

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.

Treatment and study plan

GT719 Injection

Biological

GT719 Injection

Primary outcomes

  1. 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

  2. Incidence of treatment-emergent adverse events

    Time frame: 2 years

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

Secondary outcomes

  1. Efficacy outcomes for SLE

    Time frame: 14 days; 1, 2, 3 and 6 Months post GT719 infusion

    SLE response index 4 (SR-4) response

  2. Efficacy outcomes for Systemic Sclerosis

    Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion

    ACR-CRISS score (CRISS score≥0.6 improvment, <0.6 no improvment)

  3. Efficacy outcomes for Inflammatory Myopathy

    Time frame: 14 days; 1, 2, 3, and 6 months post GT719 infusion

    Total Improvement Score (TIS)

Study contacts

Contact information is provided by the study sponsor or research team.

Zhifeng Gu

CONTACT

[email protected]

086-13706291941

Sponsors and collaborators

Lead sponsor

Grit Biotechnology

Industry

Collaborators

  • Affiliated Hospital of Nantong University

Registry information

Official study title

A Single-arm, Open-label Clinical Study of GT719 Injection for Moderate to Severe Refractory Autoimmune Disease

Important dates

Study start
2025
Primary completion
2028
Study completion
2028
First posted
Aug 20, 2025
Registry last updated
Apr 16, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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