A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus
A Phase 1 Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Moderate or Severe Systemic Lupus Erythematosus
1 other identifier
interventional
12
1 country
1
Brief 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. After recovery, participants will be injected with ATHENA CAR-T injection and followed up to 24 months.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_1
Started Jul 2024
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
April 9, 2024
CompletedFirst Posted
Study publicly available on registry
April 18, 2024
CompletedStudy Start
First participant enrolled
July 24, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 30, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 30, 2027
June 17, 2024
April 1, 2024
2.8 years
April 9, 2024
June 14, 2024
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Dose Limiting Toxicity
Dose Limiting Toxicity (DLT) is defined as AEs related to ATHENA CART from infusion till 28 days post infusion.
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).
0 day to 24 months after treatment
Secondary Outcomes (7)
Efficacy: Percent of patients achieved SRI-4
0 to 16 weeks after treatment
Efficacy: Patients SLEDAI-2000 change compared with baseline
0 to 16 weeks after treatment
Efficacy: Patients BILAG-2004 change compared with baseline
0 to 16 weeks after treatment
Efficacy: Percent of patients' PGA not worsen
0 to 16 weeks after treatment
Percent of patients responded by BILAG-2004
0 to 16 weeks after treatment
- +2 more secondary outcomes
Other Outcomes (5)
PK characteristics
0 day to 24 months after treatment
PK characteristics (cont)
0 day to 24 months after treatment
PK characteristics (cont)
0 day to 24 months after treatment
- +2 more other outcomes
Study Arms (1)
ATHENA CAR-T Arm
EXPERIMENTALA conditioning chemotherapy regimen will be administered followed by investigational treatment of ATHENA CAR-T
Interventions
Phase 1 dose escalation (3+3): dose 1 and dose 2.
Intravenous injection of fludarabine.
Intravenous injection of cyclophosphamide.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- EdiGene Inc.lead
- The First Affiliated Hospital of Henan University of Science and Technologycollaborator
- Changping Laboratorycollaborator
Study Sites (1)
The First Affiliated Hospital of Henan University of Science and Technology
Luoyang, Henan, 471003, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Xiaofei Shi, MD
The First Affiliated Hospital of Henan University of Science and Technology
Central Study Contacts
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
April 9, 2024
First Posted
April 18, 2024
Study Start
July 24, 2024
Primary Completion (Estimated)
April 30, 2027
Study Completion (Estimated)
April 30, 2027
Last Updated
June 17, 2024
Record last verified: 2024-04
Data Sharing
- IPD Sharing
- Will not share
No plan to share IPD.