CAR-TPhase 1NCT05846347
Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus
A Phase 1 study testing GC012F injection in people with CAR-T, run by Zhejiang University at 1 site in China.
Trial summary
This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- CAR-T
- 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
- 15 participants
- Where
- 1 siteChina
- Study dates
- 15 May 2023to 19 Apr 2025
- Phase
- Phase 1
- Are there results?
- None posted in the registry
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
- 18-70 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria;
- SELENA-SLEDAI≥8;
- Patients with CD19+ B-cell;
- Active organ involvement;
- Hemoglobin≥85 g/L;
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- WBC≥2.5×10^9/L
- NEUT≥1×10^9/L;
- PLT≥50×10^9/L;
- AST/ALT below 2 times the upper limit of normal; Creatinine clearance ≥30 mL/min; blood bilirubin ≤2.0 mg/dl; echocardiography indicates that the ejection fraction is ≥50%;
- Adequate venous access for apheresis, and no other contraindications for leukapheresis;
- Women of childbearing age should have a negative serum or urine pregnancy test at screening and baseline. Subjects agree to take effective contraceptive measures during the trial until at least 1 year after CAR-T cells infusion.
- Agree to attend follow-up visits as required;
- Voluntary participation and informed consent signed by the patient or his/her legal/authorized representative;
Who cannot join
- Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks prior to leukapheresis, or subjects who need prohibited drugs to treat active nephritis or subjects who need hemodialysis;
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts;
- Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system;
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis;
- Patients with HIV infection; Active infection of hepatitis B virus or hepatitis C virus; Patients with syphilis infection;
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- The presence or suspicion of an active fungal, bacterial, viral or other infection that cannot be controlled during screening;
- Received live vaccine treatment within 4 weeks prior to screening;
- Severe allergies or hypersensitivity;
- Contraindication to cyclophosphamide in combination with fludarabine;
- Subjects who have undergone major surgery within 2 weeks prior to signing the informed consent form, or who are scheduled to have surgery (other than local anesthetic surgery) during the trial or within 2 weeks of the infusion;
- cannula or drainage tubes other than central venous catheters;
- Pregnant or lactating women, or subjects who plan to have children within 1 year of treatment;
- Subjects with prior CD19 or BCMA-targeted therapy
- Participated in any clinical study within 3 months prior to enrollment
- Any situations that the investigator believes the patients are not suitable for the study.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
The First Affiliated Hospital,College of Medicine, Zhejiang University
Hangzhou, Zhejiang, 310003
He Huang, PhD, 86-13605714822, hehuangyu@126.com
Yongxian Hu, PhD, 86-15957162012, huyongxian2000@aliyun.com
About this study
This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.
Read the detailed description
Systemic lupus erythematosus (SLE) is a kind of autoimmune diseases mediated by autoantibody-forming immune complexes, which involving multiple systems and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
Traditional SLE treatment aims at long-term remission, while, CD19- BCMA CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in SLE.
- Conditions
- CAR-T
- Being tested
- GC012F injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GC012F injectionDrug
Also called CD19-BCMA CAR-T cells
Each subject will receive GC012F injection (CD19-BCMA CAR-T cells) once by intravenous infusion on Day 0.
| Study group | Role | What they receive |
|---|---|---|
| GC012F injection (CD19-BCMA CAR-T cells) | Experimental | Dose level： DL1：1±20%×10^5/kg, DL2：2±20%×10^5/kg DL3：3±20%×10^5/kg Receives: Drug: GC012F injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
The proportion of subjects with DLT
DLT definition is dose-limiting toxicity
Measured: Within 28 days after GC012F injection infusion
The proportion of subjects with adverse events
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria
Measured: Within 12 weeks after GC012F injection infusion
Secondary outcomes (2)
Proportion of subjects achieving SRI-4
SELEAN-SLEDAI，BILAG，PGA
Measured: 4, 8, 12 and 24 weeks after GC012F injection infusion
Number of CAR-T cells and CAR gene copies in subjects'blood and bone marrow (if applicable)
Test method: flow cytometry and qPCR
Measured: After GC012F injection infusion [day 4, 7, 10, 14 and week 4, 8, 12, 24]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 May 2023
- Study start15 May 2023 (estimated)
- Primary completion19 Oct 2023 (estimated)
- Study completion19 Apr 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CAR-TStudies of the same condition, open and under way.
- More trials run by Zhejiang UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhejiang University
- Sponsor type
- University, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Responsible party
- Principal investigator, He Huang, Zhejiang University
- Investigators
- He Huang, Principal investigator, Zhejiang UniversityZhihong Liu, Principal investigator, Zhejiang university school of medicineJin Lin, Principal investigator, Zhejiang University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05846347
- Sponsor's protocol ID
- GC012F-614
- Status last verified
- May 2023
- First submitted
- 26 Apr 2023
- Last updated
- 11 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase I Clinical Study of GC012F Injection in Treatment of Refractory Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT05846347
- Acronym / sponsor ID
- GC012F-614
- Conditions
- CAR-T
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Zhejiang UniversityUniversity, hospital or other
- Collaborators
- Gracell Biotechnologies (Shanghai) Co., Ltd.
- Study start
- 15 May 2023 (estimated)
- Primary completion
- 19 Oct 2023 (estimated)
- Study completion
- 19 Apr 2025 (estimated)
- First posted
- 6 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a phase I, single arm, non-randomized, open label, treatment study trial to determine the recommended phase II dose of GC012F injection (CD19-BCMA CAR-T cells) in patients with refractory systemic lupus erythematosus.
Detailed description
Systemic lupus erythematosus (SLE) is a kind of autoimmune diseases mediated by autoantibody-forming immune complexes, which involving multiple systems and organs.
Autoreactive B cells can self-activate and differentiate into plasma cells releasing large amounts of autoantibodies, while they can also present their own antigens to autoimmune T cells, thus activating T cells and promoting the release of inflammatory factors.
Traditional SLE treatment aims at long-term remission, while, CD19- BCMA CAR-T cells can theoretically completely deplete abnormal antibody-producing B cells, allowing immune rebuilding and restoring the patient's normal immune function, achieving drug-free survival, which fully reflects the application prospects of CAR-T therapy in SLE.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GC012F injection (CD19-BCMA CAR-T cells) | Experimental | Drug: GC012F injectionDose level： DL1：1±20%×10^5/kg, DL2：2±20%×10^5/kg DL3：3±20%×10^5/kg |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 18-70 years old;
- Total score ≥ 10 on the EULAR/ACR 2019 SLE classification criteria;
- SELENA-SLEDAI≥8;
- Patients with CD19+ B-cell;
- Active organ involvement;
Key exclusion criteria (16 listed)
- Renal disease: severe lupus nephritis (serum creatinine > 2.5 mg/dL or 221 μmol/L) within 8 weeks prior to leukapheresis, or subjects who need prohibited drugs to treat active nephritis or subjects who need hemodialysis;
- CNS disease: including epilepsy, psychosis, organic encephalopathy syndrome, cerebrovascular accident [CVA], encephalitis or CNS vasculitis, psychiatric patients with depression or suicidal thoughts;
- Patients with serious lesions and history of present illness of vital organs such as heart, liver, kidney and blood and endocrine system;
- Patients with immunodeficiency, uncontrolled active infections and active or recurrent peptic ulcers;
- Received immunosuppressive therapy within 1 week prior to leukapheresis;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GC012F injectionAlso: CD19-BCMA CAR-T cellsEach subject will receive GC012F injection (CD19-BCMA CAR-T cells) once by intravenous infusion on Day 0. | Drug | GC012F injection (CD19-BCMA CAR-T cells) |
Primary outcome
The proportion of subjects with DLT
Time frame: Within 28 days after GC012F injection infusion
DLT definition is dose-limiting toxicity
The proportion of subjects with adverse events
Time frame: Within 12 weeks after GC012F injection infusion
All adverse events were evaluated according to NCI-CTCAE v5.0 criteria
2 secondary outcomes
Proportion of subjects achieving SRI-4
Time frame: 4, 8, 12 and 24 weeks after GC012F injection infusion
Number of CAR-T cells and CAR gene copies in subjects'blood and bone marrow (if applicable)
Time frame: After GC012F injection infusion [day 4, 7, 10, 14 and week 4, 8, 12, 24]
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 May 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
He Huang principal investigator
Zhejiang University
Zhihong Liu principal investigator
Zhejiang university school of medicine
Jin Lin principal investigator
Zhejiang University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GC012F injection in people with CAR-T, run by Zhejiang University at 1 site 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 14 inclusion and 16 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: status not confirmed, as of the sponsor's last update on 11 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact He Huang, PhD (86-13605714822, hehuangyu@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The proportion of subjects with DLT (time frame: Within 28 days after GC012F injection infusion). 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?
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 11 May 2023.