Health TrialsbyHealthPanel

GT719 Injection for Moderate to Severe Refractory Autoimmune Disease

ConditionAuto Immune Disease
Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorGrit Biotechnology

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

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

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

  • GT719 Injection

    Biological/Vaccine

    GT719 Injection

Treatment groups

30 Participants
are divided into 1 treatment group
Group A: GT719 Injection treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Proportion of participants experiencing dose limiting toxicity

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

Time frame
28 days
2

Incidence of treatment-emergent adverse events

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

Time frame
2 years

Secondary outcomes

1

Efficacy outcomes for SLE

SLE response index 4 (SR-4) response

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

Efficacy outcomes for Systemic Sclerosis

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

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

Efficacy outcomes for Inflammatory Myopathy

Total Improvement Score (TIS)

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Grit Biotechnology

Lead sponsor

Affiliated Hospital of Nantong University

Collaborator

Source ClinicalTrials.gov
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