GT719 Injection for Moderate to Severe Refractory Autoimmune Diseases

ConditionAutoimmune Diseases

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, 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

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;

Disqualifiers

Drug induced SLE;

Patients with lupus crisis or concomitant diseases who require the use of contraindicated drugs according to the protocol are deemed unsuitable for inclusion by the investigator.

IIM participants

Documented inclusion body myositis (IBM), drug-induced PM or DM, tumor associated PM or DM, non-inflammatory myopathy (such as muscular dystrophy);

Trial design

Design model

Single group

Treatments tested in this trial

GT719 Injection
Biological/Vaccine
GT719 Injection

Treatment groups

10 Participants

are divided into 1 treatment group

Group A: GT719 Injection treatment groupExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

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

Incidence of treatment-emergent adverse events

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

Time frame

3 months

Secondary outcomes

Efficacy outcomes for SLE

SLE Response index 4(SR-4) response: Min/Max Value: Not specified; a decrease in score indicates improvment, higher scores indicate worse outcome

Time frame

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

Efficacy outcomes for Systemic Sclerosis

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

Time frame

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

Efficacy outcomes for Inflammatory Myopathy

Total lmprovement Score (TlS): Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome.

Time frame

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

Other outcomes

Efficacy outcomes for SLE

SLE Response index 4(SR-4) response: Min/Max Value: Not specified; a decrease in score indicates improvment, higher scores indicate worse outcome

Time frame

12 weeks

Efficacy outcomes for Systemic Sclerosis

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

Time frame

12 weeks

Efficacy outcomes for Inflammatory Myopathy

Total lmprovement Score (TlS): Min/Max Value: Not specified; an increase in score indicates improvement, higher scores indicate better outcome.

Time frame

12 weeks

Sponsors and contacts

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

Grit Biotechnology

Lead sponsor

Source ClinicalTrials.gov

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