A Phase 1/2 Clinical Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

Gracell Biotechnologies (Shanghai) Co., Ltd.3 sites in 1 country118 target enrollmentAugust 22, 2024

InterventionsGC012F Injection

DrugsGC012F Injection

Overview

Phase: Phase 1
Intervention: GC012F Injection
Conditions: Not specified
Sponsor: Gracell Biotechnologies (Shanghai) Co., Ltd.
Enrollment: 118
Locations: 3
Primary Endpoint: Dose-Limiting Toxicity (DLT) rate
Status: Recruiting
Last Updated: 24 days ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

Brief Summary

This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory Systemic Lupus Erythematosus (SLE).

Detailed Description

This is a single-arm, open-label, multicenter, phase 1/2 clinical study to assess the safety and efficacy of GC012F Injection in subjects with refractory SLE；The dose-escalation phase 1 study aims to assess the safety of GC012F Injection and determine the Recommended Phase II Dose (RP2D). The phase 2 study aims to determine the efficacy and safety of GC012F Injection at the RP2D in patients with refractory SLE and assess the pharmacokinetics (PK) and pharmacodynamics (PD) characteristics.

Registry

clinicaltrials.gov

Start Date

August 22, 2024

End Date

February 1, 2027

Last Updated

24 days ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Gracell Biotechnologies (Shanghai) Co., Ltd.

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Voluntarily sign the ICF;
•Males or females, aged 18-70 years old (inclusive);
•Must be able and willing to comply with the study visit schedule and other protocol requirements;
•Presence of CD19+B cells in the peripheral blood;
•Diagnosed with SLE and meeting the 2019 EULAR/ACR classification criteria for SLE;
•Used standard SLE treatment regimens and at least a biological agent for more than 6 months but did not meet the LLDAS criteria
•SLEDAI-2000 scores ≥8 during the screening period. If the scores for low complement and/or anti-ds-DNA antibody are available, the SLEDAI-2000 scores for clinical symptoms (except low complement and/or anti-ds-DNA antibody) should be NLT 4;
•Positive serological test results of autoantibodies: Positive results of antinuclear antibody (ANA) and/or anti-ds-DNA antibody and/or anti-Sm antibody, with critical values not acceptable;
•Adequate functional reserve of organs:
•Neutrophil count ≥1 × 10\^9/L, lymphocyte count ≥0.3 × 10\^9/L; hemoglobin ≥85 g/L; platelet count ≥50 × 10\^9/L;

Exclusion Criteria

•Receipt of CD19 and/or BCMA-targeted therapies or CAR T-cell therapies for any targets in the past;
•Receipt of CD20-targeted drug therapy within 6 months prior to screening;
•Receipt of immunosuppressants or prednisone \>15 mg/d or equivalent doses of other glucocorticoids within 1 week before the apheresis;
•Presence of any renal disorders: serious lupus nephritis (serum creatinine \>2.5 mg/dL or 221 μmol/L), or active nephritis requiring treatments with drugs forbidden in this protocol, or any needs for hemodialysis within 8 weeks prior to apheresis;
•Presence of any serious heart diseases as follows:
•Congestive heart failure (New York Heart Association (NYHA) Class III or IV);
•Myocardial infarction or receipt of coronary artery bypass grafting (CABG) within 6 months prior to screening;
•Clinically significant ventricular arrhythmias or a history of unexplained syncope not due to vasovagal reaction or dehydration; or a QTc interval \>480 ms during the screening;
•A medical history of severe non-ischemic cardiomyopathy;
•Need for supplemental oxygen or mechanical ventilation with oxygen saturation \<92%;