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Active, not recruitingNCT06333483CARLYSLEUpdated Jul 31, 2026

Obe-cel in Adolescent [Applicable in UK Only] and Adult Severe, Refractory Systemic Lupus Erythematosus

A Phase 1 interventional study of Obecabtagene autoleucel (obe-cel) in Systemic Lupus Erythematosus, sponsored by Autolus Limited. Active, not recruiting at 6 sites in 2 countries. Open to participants aged 12 Years and older. Per ClinicalTrials.gov, last updated 2026-07-31.

Sponsored by Autolus Limited · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
16
Allocation
Not applicable
Ages
12 Years and older
Sex
All
01

Study summary

This is a Phase 1 study of obecabtagene autoleucel (obe-cel), autologous T cells engineered with a chimeric antigen receptor (CAR) targeting CD19, to establish the tolerability, safety, preliminary efficacy, and pharmacokinetics of obe-cel in patients with severe, refractory SLE.

Read the detailed description

This is a single-arm, open-label Phase 1 Study to determine the safety, tolerability, and preliminary efficacy of obe-cel in patients with severe, refractory SLE. Up to a maximum of 18 patients will be treated in a maximum of 3 dose levels.

By using the Bayesian Optimal Interval (BOIN) design for overdose control, the Sponsor will review the Safety Review Committee (SRC) and Independent Data Monitoring Committee (IDMC) recommendation and determine if a dose level is suitable for a subsequent study.

02

Conditions studied

  • Systemic Lupus Erythematosus

Keywords

  • AUTO1
  • Obecabtagene autoleucel (obe-cel)
  • CD19-positive chimeric antigen receptor T cell
  • CAR-T
03

Who can participate

Ages eligible
12 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

-Key Inclusion Criteria-

  • Women or men ≥ 18 years at screening [Spain only] or patients 12 to 65 years of age (inclusive) at the time of signing the informed consent [UK only]
  • Diagnosis of SLE fulfilling the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria for Systemic Lupus Erythematosus
  • Positive for at least one of the following autoantibodies: antinuclear antibodies (ANA) at a titer of ≥ 1:80, or anti-dsDNA (≥ 30 IU/mL) or anti-Smith (> upper limit of normal [ULN]), anti-histone or anti-chromatin (> ULN)
  • Severe, refractory SLE

Exclusion criteria

Exclusion Criteria:

-Key Exclusion Criteria-

  • Medications

    • Within 2 months of leukapheresis: use of anti-CD20 therapy
    • Prior treatment with anti-CD19 therapy (including bispecifics), adoptive T cell therapy or any prior gene therapy product (e.g., CAR T cell therapy)
    • Immunization with a live or attenuated vaccine within 2 months of leukapheresis

  • SLE and Autoimmunity:

    • Recurrent neuropsychiatric lupus or active, severe or unstable neuropsychiatric lupus within 2 years from screening
    • Diagnosis of drug-induced SLE rather than idiopathic SLE
    • Any acute, severe lupus-related flare during screening that needs immediate treatment and/or makes the immunosuppressive washout impossible; thus, making the patient ineligible for CD19 CAR T therapy as judged by the Investigator or Sponsor
    • Significant, likely irreversible organ damage related to SLE (e.g., end-stage renal disease) that in the opinion of the Investigator renders CD19 CAR T cell therapy unlikely to benefit the patient
    • Diagnosis of another non-SLE autoimmune disease (e.g., dermatomyositis, polymyositis, scleroderma, rheumatoid arthritis) or overlap syndrome

  • Medical History:

    • History or presence of: (Within 3 months before screening visit)

      • Clinically relevant central nervous system (CNS) pathology such as epilepsy, paresis, aphasia, or stroke
      • Evidence of deep venous thrombosis or pulmonary embolism
    • History or presence of severe brain injuries, dementia, Parkinson's disease, cerebellar disease, organic brain syndrome, uncontrolled mental illness, or psychosis
    • Clinically significant, uncontrolled heart disease not due to SLE (New York Heart Association Class III or IV heart failure, uncontrolled angina, severe uncontrolled cardiac arrhythmia, or electrocardiographic evidence of acute ischemia or Grade 3 conduction system abnormalities unless the patient has a pacemaker) or a recent (within 12 months of screening) cardiac event
    • Active or uncontrolled fungal, bacterial, viral (including COVID-19), or other infection requiring systemic antimicrobials for management
    • Active or latent hepatitis B or active hepatitis C
    • Human immunodeficiency virus, human T-cell leukemia virus (HTLV)-1, HTLV-2 or syphilis positive test at screening
    • History of malignant neoplasms unless disease free for at least 24 months (basal cell or squamous cell carcinoma in situ, or in situ breast cancer on hormonal therapy allowed)
    • History of heart, lung, kidney, liver transplant or hematopoietic stem cell transplant
    • Pregnancy or lactating

  • Laboratory and Organ Function:

    • Left ventricular ejection fraction \< 45% (or \< institute's lower limit of normal) confirmed by echocardiogram
    • Oxygen saturation (SpO2) \< 90% in the absence of oxygen support
    • B cell aplasia
04

Study design

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

Study arms

  • Experimental
    AUTO1

    Biological: Obecabtagene autoleucel (obe-cel)

Interventions

  • BiologicalObecabtagene autoleucel (obe-cel)

    Following lymphodepletion with chemotherapy (cyclophosphamide and fludarabine) patients will be treated with a single dose of obe-cel

05

What researchers measure

Primary outcomes

  1. Dose-limiting toxicities

    Percentage of patients receiving obe-cel who experience dose-limiting toxicities (DLTs)

    Time frame: Up to 28 days from obe-cel infusion

  2. Adverse events

    Adverse event (AE) type, frequency, severity, and relationship with obe-cel and lymphodepletion of AEs

    Time frame: Up to Month 12

Secondary outcomes

  1. Remission rate according to Definition of Remission in SLE (DORIS)

    Remission rate as specified by Definition of Remission in SLE (DORIS)

    Time frame: Up to Month 12

  2. Response over time according to Definition of Remission in SLE (DORIS)

    Response over time as specified by Definition of Remission in SLE (DORIS)

    Time frame: Up to Month 12

  3. Time to response according to Definition of Remission in SLE (DORIS)

    Time to response as specified by Definition of Remission in SLE (DORIS)

    Time frame: Up to Month 12

  4. Change over time in Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K)

    Change compared to baseline in the Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K) score. The total score is the sum of all marked SLE-related descriptors. A total score can fall between 0 and 105, with a higher score representing a more significant degree of disease activity.

    Time frame: Up to Month 12

  5. Change over time in Physician's global assessment (PGA)

    Change compared to baseline in physician's global assessment (PGA) of average SLE disease severity on a visual analog scale (VAS) between 0 and 3 where 0 represents no disease, 1 represents mild disease activity, 2 represents moderate disease activity, and 3 represents a severe disease activity (highest and most severe possible disease activity). At least 10% change improvement or worsening in PGA to be clinically significant compared to baseline

    Time frame: Up to Month 12

  6. Pharmacokinetics (maximum serum concentration [Cmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood

    Detection of CAR T cells measured by PCR in the peripheral blood after obe-cel infusion

    Time frame: Up to Month 12

  7. Pharmacokinetics (time to reaching maximum serum concentration [Tmax]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood

    Detection of CAR T cells measured by PCR in the peripheral blood after obe-cel infusion

    Time frame: Up to Month 12

  8. Pharmacokinetics (area under the curve [AUC]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood

    Detection of CAR T cells measured by PCR in the peripheral blood after obe-cel infusion

    Time frame: Up to Month 12

  9. Pharmacokinetics (last observed quantifiable concentration [Clast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood

    Detection of CAR T cells measured by PCR in the peripheral blood after obe-cel infusion

    Time frame: Up to Month 12

  10. Pharmacokinetics (time to reach last observed quantifiable concentration [Tlast]): Detection of CAR-T cells by polymerase chain reaction (PCR) in peripheral blood

    Detection of CAR T cells measured by PCR in the peripheral blood after obe-cel infusion

    Time frame: Up to Month 12

  11. Pharmacodynamics: B cell aplasia

    Depletion of circulating B cells in the peripheral blood

    Time frame: Up to Month 12

06

Study locations

6 sites
  • Hospital Universitari Vall Hebrón
    Barcelona, 08035, Spain
  • Hospital Universitari i Politecnic La Fe
    Valencia, 106046026, Spain
  • Addenbrookes Hospital
    Cambridge, CB2 0QQ, United Kingdom
  • University College London Hospitals NHS Foundation Trust
    London, NW1 2PG, United Kingdom
  • Great Ormond Street Hospital
    London, WC1N 3JH, United Kingdom
  • Manchester Royal Infirmary, Manchester University NHS Foundation Trust,
    Manchester, M13 9WL, United Kingdom
07

Registry details

Key details

Study ID
NCT06333483
Lead sponsor
Autolus Limited
Responsible party
Sponsor
First posted
Mar 27, 2024
Start date
Feb 2, 2024
Primary completion
Sep 2027 (estimated)
Completion
Sep 2027 (estimated)
Last update
Jul 31, 2026

Oversight

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

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