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Systemic Lupus ErythematosusPhase 1CARLYSLENCT06333483

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

A Phase 1 study testing Obecabtagene autoleucel (obe-cel) in people with Systemic Lupus Erythematosus, run by Autolus Limited at 6 sites in 2 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial 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 more about this study

Who is it for?
Ages 12 years and older
Conditions the study is for
Systemic Lupus Erythematosus
What is being tested?
Obecabtagene autoleucel (obe-cel)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
16 participants
Where
6 sitesin 2 countries
Study dates
2 Feb 2024to Sep 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 12 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • -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

Who cannot join

  • -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:
Show all 27Show fewer
  • 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

Trial locations and contacts

6 sites in 2 countries.

6 sites in 2 countries

United Kingdom4 sites

  • Addenbrookes Hospital

    Cambridge, CB2 0QQ

  • University College London Hospitals NHS Foundation Trust

    London, NW1 2PG

  • Great Ormond Street Hospital

    London, WC1N 3JH

  • Manchester Royal Infirmary, Manchester University NHS Foundation Trust,

    Manchester, M13 9WL

Other trials in United Kingdom

Spain2 sites

  • Hospital Universitari Vall Hebrón

    Barcelona, 08035

  • Hospital Universitari i Politecnic La Fe

    Valencia, 106046026

Other trials in Spain

About this study

Official title: A Single-Arm, Open-Label, Phase I Study to Determine the Safety, Tolerability and Preliminary Efficacy of Obecabtagene Autoleucel in Patients With Severe, Refractory Systemic Lupus Erythematosus

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.

Being tested
Obecabtagene autoleucel (obe-cel)
Keywords
AUTO1, Obecabtagene autoleucel (obe-cel), CD19-positive chimeric antigen receptor T cell, CAR-T
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.

  • Obecabtagene autoleucel (obe-cel)Biological

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

Study groups in NCT06333483
Study groupRoleWhat they receive
AUTO1ExperimentalNot described
Receives: Biological: Obecabtagene autoleucel (obe-cel)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Dose-limiting toxicities

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

    Measured: 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

    Measured: Up to Month 12

Secondary outcomes (11)

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

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

    Measured: 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)

    Measured: 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)

    Measured: 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.

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: 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

    Measured: Up to Month 12

  11. Pharmacodynamics: B cell aplasia

    Depletion of circulating B cells in the peripheral blood

    Measured: Up to Month 12

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2024
  2. Study start2 Feb 2024
  3. Primary completionSep 2027 (estimated)
  4. Study completionSep 2027 (estimated)

Resources

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
16 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06333483
Sponsor's protocol ID
AUTO1-SL1
Other IDs
2023-508236-60-00, 2023
Acronym
CARLYSLE
Status last verified
Jul 2026
First submitted
6 Mar 2024
Last updated
31 Jul 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 1 study testing Obecabtagene autoleucel (obe-cel) in people with Systemic Lupus Erythematosus, run by Autolus Limited at 6 sites in 2 countries.

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 5 inclusion and 27 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: under way, not looking for participants, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 6 sites in United Kingdom, Spain. 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?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicities (time frame: Up to 28 days from obe-cel infusion). 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?

On the ClinicalTrials.gov record for NCT06333483.

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 31 Jul 2026.

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