Lupus Erythematosus, SystemicPhase 1NCT06373991
A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
A Phase 1 study testing ATHENA CAR-T, Fludarabine and Cyclophosphamide in people with Lupus Erythematosus, Systemic, run by EdiGene Inc. at 1 site in China.
Trial summary
The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is: To evaluate the safety and tolerability of ATHENA CAR-T. After screening, participants will be subjected to lymphodepletion regimen. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Lupus Erythematosus, Systemic
- What is being tested?
- ATHENA CAR-T, Fludarabine and Cyclophosphamide
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteChina
- Study dates
- 24 Jul 2024to 30 Apr 2027
- Phase
- Phase 1
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Male or Female, between 18 and 56 years old;
- diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- anti-Nuclear Antigen Ab positive (titer NLT 1:80) and/or dsDNA ab positive and/or Anti-Sm ab positive at screening;
- at screening, SLEDAI-2000 scoring NLT 8 points, if low complement scoring and/or anti-dsDNA ab scoring is available, the SLEDAI-2000 scoring except low complement and anti-dsDNA ab should be NLT 6 points;
- should be subjected to at least 6 months of standard treatment for SLE, and disease active at least two months before screening;
- good organ functions;
- trial participants whose partner is fertile agree to use effective contraceptives til 24 months post transfusion, fertile female participants should have negative urine/blood pregnancy test results (participants who were sterilized or menopause for MT 12 months is not considered fertile);
- voluntary participates this trial and can comprehend and sign ICF.
Who cannot join
- Had or has active malignancy;
- had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- within 8 weeks before screening, had CNS disease caused by SLE or non-SLE diseases;
- within 8 weeks before screening, had lupus crisis;
- has following kidney diseases: within 8 weeks before randomization, had SLE with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone MT 100mg/d for longer than 14d or equivalent therapy;
- had serious allergy to any lymphodepletion medication or ingredients of ATHENA CAR-T;
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- has uncontrolled fungi, bacterial or viral infection or other infections investigator deemed not suitable to participate in the study;
- combined with other autoimmune disease that needs treatment;
- pregnant or lactating women;
- has other factors that deemed not suitable by investigator.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003
Muchen Liu, (86)-13663884080
About this study
Official title: A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus
The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:
- To evaluate the safety and tolerability of ATHENA CAR-T.
After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.
Read the detailed description
This study is a single center, one-arm, open label, phase I study aimed at evaluate the safety and effectiveness of ATHENA CAR-T treating moderate to severe SLE patients.
A traditional "3+3" design is used with two doses. DLT is monitored. Safety and effectiveness are followed up until 24 months post infusion of ATHENA CAR-T. Besides safety monitoring, efficacy is evaluated via SLEDAI-2000, BILAG-2004, PGA.
- Conditions
- Lupus Erythematosus, Systemic
- Being tested
- ATHENA CAR-T, Fludarabine, Cyclophosphamide
- Keywords
- Adult moderate to serve SLE
- 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.
ATHENA CAR-TBiological
Also called ET-901
Phase 1 dose escalation (3+3): dose 1 and dose 2.
FludarabineDrug
Also called Fludarabine Phosphate for Injection
Intravenous injection of fludarabine.
CyclophosphamideDrug
Also called Cyclophosphamide for Injection
Intravenous injection of cyclophosphamide.
| Study group | Role | What they receive |
|---|---|---|
| ATHENA CAR-T Arm | Experimental | A conditioning chemotherapy regimen will be administered followed by investigational treatment of ATHENA CAR-T Receives: Biological: ATHENA CAR-T; Drug: Fludarabine; Drug: Cyclophosphamide |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT) is defined as AEs related to ATHENA CART from infusion till 28 days post infusion.
Measured: 0~28 day after treatment
Frequency of AEs, SAEs, lab abnormalities, AESIs
Monitor grade and frequency of Adverse Events (AEs), Severe Adverse Events (SAEs), abnormal laboratory findings and Adverse Events of Special Interest (AESI).
Measured: 0 day to 24 months after treatment
Secondary outcomes (7)
Efficacy: Percent of patients achieved SRI-4
Measure percentage of patients who achieved SRI-4 (Systemic Lupus Erythematosus Responder Index-4) at week 4,8,12,16. SRI-4 response is achieved if SLEDAI-2000 score is lowered NLT 4pt compared to baseline, BILAG-2004 has no new A grade or NMT 1 new B grade, and PGA is not worsen (increase LT 0.3 compare to baseline).
Measured: 0 to 16 weeks after treatment
Efficacy: Patients SLEDAI-2000 change compared with baseline
Compare patients' SLEDAI-2000 (Systemic Lupus Erythematosus Disease Activity Index 2000) value at baseline and week 4,8,12,16. SLEDAI-2000 is an index of range 0 to 105. Higher score indicates stronger disease activity, a score NLT 15 means strong SLE activity.
Measured: 0 to 16 weeks after treatment
Efficacy: Patients BILAG-2004 change compared with baseline
Compare patients' BILAG-2004 (British Isles Lupus Assessment Group index 2004) value at baseline and week 4,8,12,16. Each organ system is graded from A to E, A indicate high disease activity while grade E indicate no disease activity now and then. A is assigned 9 points and E is assigned 0 points.
Measured: 0 to 16 weeks after treatment
Efficacy: Percent of patients' PGA not worsen
Measure percentage of patients whose PGA (Physician Global Assessment) is not worsen (increase LT 0.3 compare to baseline) at week 4,8,12,16. PGA is ranged 0 to 3, score 0 means no disease activity while score 3 means strong disease activity.
Measured: 0 to 16 weeks after treatment
Percent of patients responded by BILAG-2004
Measure percentage of patients who responded by BILAG-2004 (no new A grade or NMT 1 new B grade) at week 4,8,12,16.
Measured: 0 to 16 weeks after treatment
Efficacy: Immunologic parameters
Evaluate the change of immunological parameters. Including of concentration of IgG, IgA, IgM, C3, C4, unit g/L.
Measured: 0 day to 24 months after treatment
Efficacy: Immunologic parameters (cont)
Evaluate the change of immunological parameters. Including concentration of anti-dsDNA antibody, unit IU/ml.
Measured: 0 day to 24 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2024
- Study start24 Jul 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus Erythematosus, SystemicStudies of the same condition, open and under way.
- 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
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- EdiGene Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Henan University of Science and Technology, Changping Laboratory
- Responsible party
- Sponsor
- Investigators
- Xiaofei Shi, MD, Principal investigator, The First Affiliated Hospital of Henan University of Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06373991
- Sponsor's protocol ID
- EDI-901-SLE01
- Status last verified
- Apr 2024
- First submitted
- 9 Apr 2024
- Last updated
- 17 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No plan to share IPD.
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus
- ClinicalTrials.gov ID
- NCT06373991
- Acronym / sponsor ID
- EDI-901-SLE01
- Conditions
- Lupus Erythematosus, Systemic
- Keywords
- Adult moderate to serve SLE
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- EdiGene Inc.Industry (pharma, biotech, devices)
- Collaborators
- The First Affiliated Hospital of Henan University of Science and Technology, Changping Laboratory
- Study start
- 24 Jul 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Apr 2024 (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.
The goal of this clinical trial is to test ATHENA CAR-T injection in adults with moderate to severe Systemic Lupus Erythematosus. The main question it aims to answer is:
- To evaluate the safety and tolerability of ATHENA CAR-T.
After screening, participants will be subjected to lymphodepletion regimen. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.
Detailed description
This study is a single center, one-arm, open label, phase I study aimed at evaluate the safety and effectiveness of ATHENA CAR-T treating moderate to severe SLE patients.
A traditional "3+3" design is used with two doses. DLT is monitored. Safety and effectiveness are followed up until 24 months post infusion of ATHENA CAR-T. Besides safety monitoring, efficacy is evaluated via SLEDAI-2000, BILAG-2004, PGA.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ATHENA CAR-T Arm | Experimental | Biological: ATHENA CAR-T, Drug: Fludarabine, Drug: CyclophosphamideA conditioning chemotherapy regimen will be administered followed by investigational treatment of ATHENA CAR-T |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Male or Female, between 18 and 56 years old;
- diagnosed with SLE according to 2019 EULAR/ACR SLE classifications;
- anti-Nuclear Antigen Ab positive (titer NLT 1:80) and/or dsDNA ab positive and/or Anti-Sm ab positive at screening;
- at screening, SLEDAI-2000 scoring NLT 8 points, if low complement scoring and/or anti-dsDNA ab scoring is available, the SLEDAI-2000 scoring except low complement and anti-dsDNA ab should be NLT 6 points;
- should be subjected to at least 6 months of standard treatment for SLE, and disease active at least two months before screening;
Key exclusion criteria (10 listed)
- Had or has active malignancy;
- had been subjected to treatment by CD19 targeted therapy or CAR-T therapy or any gene therapy;
- within 8 weeks before screening, had CNS disease caused by SLE or non-SLE diseases;
- within 8 weeks before screening, had lupus crisis;
- has following kidney diseases: within 8 weeks before randomization, had SLE with serious kidney involvement or need treatment using medications prohibited by protocol to treat active nephritis, or need hemodialysis or need treatment by prednisone MT 100mg/d for longer than 14d or equivalent therapy;
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 |
|---|---|---|
| ATHENA CAR-TAlso: ET-901Phase 1 dose escalation (3+3): dose 1 and dose 2. | Biological | ATHENA CAR-T Arm |
| FludarabineAlso: Fludarabine Phosphate for InjectionIntravenous injection of fludarabine. | Drug | ATHENA CAR-T Arm |
| CyclophosphamideAlso: Cyclophosphamide for InjectionIntravenous injection of cyclophosphamide. | Drug | ATHENA CAR-T Arm |
Primary outcome
Dose Limiting Toxicity
Time frame: 0~28 day after treatment
Dose Limiting Toxicity (DLT) is defined as AEs related to ATHENA CART from infusion till 28 days post infusion.
Frequency of AEs, SAEs, lab abnormalities, AESIs
Time frame: 0 day to 24 months after treatment
Monitor grade and frequency of Adverse Events (AEs), Severe Adverse Events (SAEs), abnormal laboratory findings and Adverse Events of Special Interest (AESI).
7 secondary outcomes
Efficacy: Percent of patients achieved SRI-4
Time frame: 0 to 16 weeks after treatment
Efficacy: Patients SLEDAI-2000 change compared with baseline
Time frame: 0 to 16 weeks after treatment
Efficacy: Patients BILAG-2004 change compared with baseline
Time frame: 0 to 16 weeks after treatment
Efficacy: Percent of patients' PGA not worsen
Time frame: 0 to 16 weeks after treatment
Percent of patients responded by BILAG-2004
Time frame: 0 to 16 weeks after treatment
Efficacy: Immunologic parameters
Time frame: 0 day to 24 months after treatment
Efficacy: Immunologic parameters (cont)
Time frame: 0 day to 24 months after treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 2024.
- Individual participant dataSharing planned: No. No plan to share IPD.
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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.
Xiaofei Shi, MD principal investigator
The First Affiliated Hospital of Henan University of Science and Technology
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 ATHENA CAR-T, Fludarabine and Cyclophosphamide in people with Lupus Erythematosus, Systemic, run by EdiGene Inc. 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 8 inclusion and 10 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: opening soon, as of the sponsor's last update on 17 Jun 2024. 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?
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?
Contact Chao Liu ((86)-10-80733899 ext. 8039, cliu@edigene.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dose Limiting Toxicity (time frame: 0~28 day after treatment). 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 17 Jun 2024.