A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
NCT ID: NCT06373991
Last Updated: 2024-06-17
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
PHASE1
12 participants
INTERVENTIONAL
2024-07-24
2027-04-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
• 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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Safety, Efficacy and Cellular Metabolic Dynamics of ct1192 in Patients With Moderate to Severe Refractory SLE
NCT07031713
A Study of CAR-T Cells in Subjects With Systemic Lupus Erythematosus
NCT06900764
A Clinical Study Exploring the Safety, Efficacy and Cell Metabolic Dynamics of Universal CD19 / 20 Car-t Cell Injection in Moderate to Severe Refractory Systemic Lupus Erythematosus
NCT07339332
Clinical Study Evaluating the Safety and Efficacy of IC19 CAR-T Cell Therapy for Refractory Systemic Lupus Erythematosus
NCT06886919
A Clinical Study of CD19 CAR-T in Active Systemic Lupus Erythematosus
NCT06106906
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
ATHENA CAR-T Arm
A conditioning chemotherapy regimen will be administered followed by investigational treatment of ATHENA CAR-T
ATHENA CAR-T
Phase 1 dose escalation (3+3): dose 1 and dose 2.
Fludarabine
Intravenous injection of fludarabine.
Cyclophosphamide
Intravenous injection of cyclophosphamide.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
ATHENA CAR-T
Phase 1 dose escalation (3+3): dose 1 and dose 2.
Fludarabine
Intravenous injection of fludarabine.
Cyclophosphamide
Intravenous injection of cyclophosphamide.
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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.
Exclusion Criteria
* 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;
* 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.
18 Years
65 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
The First Affiliated Hospital of Henan University of Science and Technology
OTHER
Changping Laboratory
OTHER
EdiGene Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Xiaofei Shi, MD
Role: PRINCIPAL_INVESTIGATOR
The First Affiliated Hospital of Henan University of Science and Technology
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, China
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Muchen Liu
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
EDI-901-SLE01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.