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Refractory Systemic Lupus ErythematosusPhase 1/2NCT06530849

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

A Phase 1/2 study testing GC012F Injection in people with Refractory Systemic Lupus Erythematosus, run by Gracell Biotechnologies (Shanghai) Co., Ltd. at 2 sites in China.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Refractory Systemic Lupus Erythematosus
What is being tested?
GC012F Injection
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
20 participants
Where
2 sitesChina
Study dates
22 Aug 2024to 1 Feb 2027
Phase
Phase 1/2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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:
  • Have a negative serum β-hCG pregnancy test confirmed by investigators during the screening period;
  • Agree and be able to use effective contraceptives continuously from the screening to at least 1 year after the infusion of GC012F Injection. Contraceptive methods must include one highly effective method and one additional effective (barrier) method, which should be used from the screening until at least 1 year after the infusion of GC012F Injection or until absence of CAR-T cells shown by two consecutive qPCR assays (whichever occurs later);
  • Agree to avoid breastfeeding during the study period until at least 1 year after the infusion of GC012F Injection or until absence of CAR-T cells shown by two consecutive quantitative polymerase chain reaction (qPCR) assays (whichever occurs later);
  • Male subjects must agree to use condoms during sexual contact with pregnant females or females of childbearing potential for at least 1 year after the infusion of GC012F Injection, even if a successful vasectomy has been performed;
  • Venous access available for blood collection, and no contraindications for leukapheresis.

Who cannot join

  • 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);
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  • 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;
  • Any positive results of the following items: Human immunodeficiency virus (HIV) antibody positive; HBsAg positive; or HBcAb positive (subjects with HBV DNA copy numbers below the lower limit of detection can be enrolled); hepatitis C antibody (HCV-Ab) positive (the subjects with HCV RNA below the lower limit of detection can be enrolled) or a known medical history of hepatitis C; treponema pallidum antibody (TP-Ab) positive;
  • Receipt of a live-attenuated vaccine within 4 weeks prior to apheresis;
  • A history of severe hypersensitivity or allergy;
  • Contraindication or hypersensitivity to fludarabine, cyclophosphamide, and any component of the investigational product;
  • Receipt of surgeries within 2 weeks prior to apheresis or a plan to receive surgeries during the study (except for a plan of local anesthesia surgery, which should not be performed within 2 weeks after infusion);
  • Pregnant women or lactating women who do not agree to abstain from breastfeeding, and men and women who have a fertility plan during the participation in this study or within 1 year after receiving the study treatment;
  • Participation in any other clinical trials within 4 weeks prior to signing the informed consent form, or the date of signing the informed consent form still within 5 half-lives of the last dose of the drug of the last clinical trial (whichever is longer);
  • Any situations that may hinder the participation of the subjects in the entire trial or confound the results, or any situations in which investigators believe that the participation in this study is not in the best interests of the subjects.

Trial locations and contacts

2 sites in 1 country.

China2 sites

  • Research Site

    Shanghai

  • Research Site

    Wuhan, 430060

Other trials in China

About this study

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

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).

Read the 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.

Being tested
GC012F Injection
Medical subject headings
Lupus Erythematosus, Systemic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • GC012F InjectionDrug

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

Study groups in NCT06530849
Study groupRoleWhat they receive
GC012F InjectionExperimentalGC012F Injection
Receives: Drug: GC012F Injection

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-Limiting Toxicity (DLT) rate

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

    Measured: 28 days

  2. SLE Responder Index (SRI)-4 response rate

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

    Measured: 48 weeks

Secondary outcomes (9)

  1. adverse events (AEs)

    Proportions of subjects with AEs after the infusion;

    Measured: 48 weeks

  2. SRI-4 response rate

    Proportions of subjects achieving SLE Responder Index (SRI)-4 response by timepoint;

    Measured: 48 weeks

  3. Definitions of Remission in SLE (DORIS) rate

    Proportions of subjects achieving remission according to the DORIS by timepoint;

    Measured: 48 weeks

  4. lupus low disease activity state (LLDAS) rate

    Proportions of subjects achieving LLDAS by timepoint;

    Measured: 48 weeks

  5. complete remission (CR) rate

    Proportions of subjects achieving CR by timepoint;

    Measured: 48 weeks

  6. SRI-4 response duration

    Maintenance time of SRI-4 response;

    Measured: 48 weeks

  7. DORIS duration

    Maintenance time of remission according to the DORIS;

    Measured: 48 weeks

  8. LLDAS duration

    Maintenance time of LLDAS;

    Measured: 48 weeks

  9. CR duration

    Maintenance time of complete remission

    Measured: 48 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted31 Jul 2024
  2. Study start22 Aug 2024
  3. Primary completion1 Feb 2027 (estimated)
  4. Study completion1 Feb 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
20 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06530849
Sponsor's protocol ID
D8313C00002
Status last verified
Sep 2026
First submitted
25 Jul 2024
Last updated
9 Sep 2026
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing GC012F Injection in people with Refractory Systemic Lupus Erythematosus, run by Gracell Biotechnologies (Shanghai) Co., Ltd. at 2 sites in China.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 23 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-Limiting Toxicity (DLT) rate (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06530849.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2026.

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