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Not yet recruitingNCT06373991Updated Jun 17, 2024

A Study to Evaluate the Safety and Efficacy of ATHENA CAR-T in Subjects With Systemic Lupus Erythematosus

A Phase 1 interventional study of ATHENA CAR-T and Fludarabine in Lupus Erythematosus, Systemic, sponsored by EdiGene Inc.. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2024-06-17.

Sponsored by EdiGene Inc. · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
12
Allocation
Not applicable
Ages
18 Years to 65 Years
Sex
All
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Study 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.

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.

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Conditions studied

  • Lupus Erythematosus, Systemic

Keywords

  • Adult moderate to serve SLE
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In context

Lupus Erythematosus, Systemic

1,202 studies on the registry are indexed under Lupus Erythematosus, Systemic; 399 are open to participants now.

This study's planned enrollment of 12 is below the median of 50 across 867 interventional studies indexed under Lupus Erythematosus, Systemic.

Browse Lupus Erythematosus, Systemic studies →

Lead sponsor

This is the only study on the registry with EdiGene Inc. as lead sponsor.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • 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.

Exclusion criteria

Exclusion Criteria:

  • 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.
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Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
12 participants (estimated)

Study arms

  • Experimental
    ATHENA CAR-T Arm

    A conditioning chemotherapy regimen will be administered followed by investigational treatment of ATHENA CAR-T

    Biological: ATHENA CAR-T · Drug: Fludarabine · Drug: Cyclophosphamide

Interventions

  • BiologicalATHENA CAR-T

    Phase 1 dose escalation (3+3): dose 1 and dose 2.

    Also known as: ET-901

  • DrugFludarabine

    Intravenous injection of fludarabine.

    Also known as: Fludarabine Phosphate for Injection

  • DrugCyclophosphamide

    Intravenous injection of cyclophosphamide.

    Also known as: Cyclophosphamide for Injection

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What researchers measure

Primary outcomes

  1. Dose Limiting Toxicity

    Dose Limiting Toxicity (DLT) is defined as AEs related to ATHENA CART from infusion till 28 days post infusion.

    Time frame: 0~28 day after treatment

  2. 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).

    Time frame: 0 day to 24 months after treatment

Secondary outcomes

  1. 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).

    Time frame: 0 to 16 weeks after treatment

  2. 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.

    Time frame: 0 to 16 weeks after treatment

  3. 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.

    Time frame: 0 to 16 weeks after treatment

  4. 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.

    Time frame: 0 to 16 weeks after treatment

  5. 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.

    Time frame: 0 to 16 weeks after treatment

  6. Efficacy: Immunologic parameters

    Evaluate the change of immunological parameters. Including of concentration of IgG, IgA, IgM, C3, C4, unit g/L.

    Time frame: 0 day to 24 months after treatment

  7. Efficacy: Immunologic parameters (cont)

    Evaluate the change of immunological parameters. Including concentration of anti-dsDNA antibody, unit IU/ml.

    Time frame: 0 day to 24 months after treatment

Other outcomes

  1. PK characteristics

    Evaluate main PK parameters of ATHENA CAR-T, including Cmax, unit CAR+ T cell/l.

    Time frame: 0 day to 24 months after treatment

  2. PK characteristics (cont)

    Evaluate main PK parameters of ATHENA CAR-T, including Tmax, unit day.

    Time frame: 0 day to 24 months after treatment

  3. PK characteristics (cont)

    Evaluate main PK parameters of ATHENA CAR-T, including AUC0-28d and AUC0-last, both unit are day\*CAR+T cell/l.

    Time frame: 0 day to 24 months after treatment

  4. PD characteristics

    Evaluate change of CD19+ cell number, unit CD19 cell/l, before and after infusion of ATHENA CAR-T.

    Time frame: 0 day to 24 months after treatment

  5. PD characteristics (cont)

    Evaluate change of serum cytokine level, including but not limited to TNF-alpha and IFN-gamma, unit pg/ml, before and after infusion of ATHENA CAR-T.

    Time frame: 0 day to 24 months after treatment

07

Study locations

1 site
  • The First Affiliated Hospital of Henan University of Science and Technology
    Luoyang, Henan 471003, China
    • Muchen Liu · Contact · (86)-13663884080
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References and documents

Individual participant data

Plan to share: No — No plan to share IPD.

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 17, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06373991
Lead sponsor
EdiGene Inc.
Collaborators
The First Affiliated Hospital of Henan University of Science and Technology, Changping Laboratory
Responsible party
Sponsor
First posted
Apr 18, 2024
Start date
Jul 24, 2024 (estimated)
Primary completion
Apr 30, 2027 (estimated)
Completion
Apr 30, 2027 (estimated)
Last update
Jun 17, 2024

Study contacts

Chao Liu
Contact
cliu@edigene.com
(86)-10-80733899 ext. 8039
Yiding Zhao, PhD
Contact
ydzhao@edigene.com
(86)-10-80733899 ext. 8103
Xiaofei Shi, MD
principal investigator · The First Affiliated Hospital of Henan University of Science and Technology

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is not yet recruiting, as verified in Apr 2024. You cannot join it, but the record below documents what was studied.

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