A Study of GC012F Injection in Subjects With Refractory Systemic Lupus Erythematosus

NCT06530849 | Recruiting Phase 1

• 1 other identifier: D8313C00002
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 2

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).

Conditions

Refractory Systemic Lupus Erythematosus

Outcome Measures

Primary Outcomes (2)

• Dose-Limiting Toxicity (DLT) rate

  Phase 1 study：Proportions of subjects with DLT within 28 days after infusion.

  28 days

• SLE Responder Index (SRI)-4 response rate

  Phase 2 study：Proportion of subjects achieving SRI-4 response at Week 48.

  48 weeks

Secondary Outcomes (9)

• adverse events (AEs)

  48 weeks

• SRI-4 response rate

  48 weeks

• Definitions of Remission in SLE (DORIS) rate

  48 weeks

• lupus low disease activity state (LLDAS) rate

  48 weeks

• complete remission (CR) rate

  48 weeks

Study Arms (1)

GC012F Injection

EXPERIMENTAL

GC012F Injection

Drug: GC012F Injection

Interventions

GC012F Injection DRUG

GC012F Injection is an autologous chimeric antigen receptor T cell therapy targeting both BCMA and CD19

GC012F Injection

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• ALT ≤3 × ULN; AST ≤3 × ULN; TBIL ≤2 × ULN;
• Creatinine clearance ≥40 mL/min;
• Left ventricular ejection fraction (LVEF) ≥45% and no pericardial effusion with clinical significance as diagnosed by echocardiography; no abnormal ECG with clinical significance;
• Oxygen saturation ≥92%; no pleural effusion with clinical significance.
• Females of childbearing potential must:

You may not qualify if:

• 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%;
• Hypertension uncontrolled by drug therapies;
• A medical history of any central nervous system (CNS) or neurodegenerative diseases due to or not due to SLE
• Clinically significant hemorrhage symptoms or definite bleeding tendencies (such as gastrointestinal bleeding and bleeding gastric ulcer), hereditary or acquired bleeding and thrombophilia (such as hemophilia, coagulation disorder, and hypersplenism) within 3 months prior to screening; arteriovenous thrombosis events, such as cerebrovascular diseases (including cerebral hemorrhage and cerebral infarction), deep vein thrombosis, and/or pulmonary embolism within 6 months prior to screening;
• Any history of active malignancy or malignancy within 5 years prior to screening. The following circumstances should be excluded: early-stage tumors that have received radical treatment (carcinoma in situ or grade 1 tumors, or non-ulcerative primary melanoma with a depth \<1 mm and no involvement of lymph nodes), basal cell carcinoma, squamous cell carcinoma, cervical carcinoma in situ, or breast cancer in situ that has received potential radical treatment;
• Immunodeficiency, active viral or bacterial infection (requiring systemic antimicrobial therapy) or uncontrolled systemic fungal infection;

Sponsors & Collaborators

• Gracell Biotechnologies (Shanghai) Co., Ltd.: lead
• AstraZeneca: collaborator
• Suzhou Gracell Biotechnologies Co., Ltd.: collaborator

Study Sites (2)

Research Site

Shanghai, China

RECRUITING

Research Site

Wuhan, 430060, China

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Lupus Erythematosus, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Central Study Contacts

AstraZeneca Clinical Study Information Center, Doctor

CONTACT

1-877-240-9479; information.center@astrazeneca.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 25, 2024
• First Posted: July 31, 2024
• Study Start: August 22, 2024
• Primary Completion (Estimated): February 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: April 8, 2026

Record last verified: 2026-03

Locations

CN (2)