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Systemic Lupus Erythematosus (SLE)Phase 1NCT06980597

A Study of OL-108 in Relapsed/Refractory Autoimmune Diseases

A Phase 1 study testing OL-108 in people with Systemic Lupus Erythematosus (SLE) and Idiopathic Inflammatory Myopathy (IIM), run by Beijing GoBroad Hospital at 2 sites in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases. Read more about this study

Who is it for?
Ages 18 to 65 years
What is being tested?
OL-108
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
44 participants
Where
2 sitesChina
Study dates
Jun 2025to Dec 2028
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 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • General:
  • Adults aged 18-65 years old
  • ECOG 0-2
  • Adequate organ function
  • Females of childbearing potential (FCBP) must have a negative pregnancy test at screening and must agree to use a highly effective contraceptive method starting from the time of lymphodepletion and for 2 years after dosing of the IMP
  • SLE specific:
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  • Fulfilling the 1997 ACE SLE criteria/ 2012 SLICC criteria/ 2019 ACR/EULAR classification criteria of SLE; b) A positive ANA titer (≥ 1:80) and/or presence of anti-dsDNA, or anti-Sm antibodies; c) Active disease at screening, defined as SLEDAI-2K≥8 AND clinical SLEDAI-2K≥6, AND ≥1 organ system with a British Isles Lupus Assessment (BILAG) A score (severe disease activity) or ≥2 organ systems with a BILAG B score (moderate disease activity), AND PGA≥ 1; OR biopsy proven 2003 ISN/RPS class III/IV +/- class V lupus nephritis; d) relapsed or refractory to at least one immunosuppressant or biologic.
  • IIM specific:
  • Fulfilling the 2017 ACR/EULAR classification criteria for DM, PM, ADM, ASS and IMNM; b) Active disease as defined by at least one of the following criteria: at least one muscle enzyme > ULN in the past 4 weeks, active disease by EMG/muscle biopsy/MRI in the past 3 months, active DM rash; c)MMT < 142 and 2 of the following criteria: VAS patients Global ≥ 2 cm, VAS physician Global ≥ 2 cm, HAQ > 0.25, at least one muscle enzyme > 1.5x ULN, MDAAT ≥ 2 ; d) CDASI ≥14 if with skin involvement; e) At least one myositis-specific or associated antibody positive; f)relapsed or refractory to at least one immunosuppressant or biologic.
  • SSc specific:
  • a)Fulfilling the 2013 ACR/EULAR classification criteria of SSc; b) Active disease as defined by one of following: new or progressing skin manifestation/vital organ involvement within 6 months prior to screening, CRP≥6 mg/L, ESR≥28 mm/h, platelet ≥330 × 10⁹/L; c) mRSS score >10; d)relapsed or refractory to at least one immunosuppressant or biologic.
  • AAV specific:
  • Fulfilling the 2022 ACR/EULAR classification criteria for MPA/GPA; b) Presence of ANCA to either proteinase 3 or myeloperoxidase; c)At least one major or three non-major items or at least two renal items of hematuria and proteinuria on the BVAS; d)relapsed or refractory to at least one immunosuppressant or biologic.

Who cannot join

  • Active uncontrolled infection
  • Serologic evidence of chronic hepatitis B virus (HBV) infection and unable or unwilling to receive standard prophylactic antiviral therapy or with detectable HBV viral load
  • Serologic evidence of hepatitis C virus (HCV) infection without completion of curative treatment or with detectable HCV viral load
  • HIV antibody positive
  • Syphilis antibody positive
  • Active tuberculosis, untreated or inadequately treated latent tuberculosis infection (LTBI)
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  • History of serious infection within 3 months prior to screening (defined as requiring hospitalization or intravenous antimicrobial therapy), or history of oral antimicrobial therapy within 1 month prior to screening (e.g., viral infections, opportunistic infections, including but not limited to severe cytomegalovirus or herpes virus infections)
  • Congenital long QT syndrome or a corrected QTcF interval of ≥480 ms at screening (unless secondary to pacemaker or bundle branch block)
  • Uncontrolled hypertension (blood pressure ≥160/100 mm Hg repeatedly), unstable angina, congestive heart failure (greater than New York Heart Association class II), electrocardiographic evidence of acute ischemia, coronary angioplasty or myocardial infarction within 6 months prior to screening, uncontrolled atrial or ventricular cardiac arrhythmia, poorly controlled diabetes or other endocrine diseases, severe chronic pulmonary disease, or other serious medical condition which is likely to significantly impair the patient's ability to tolerate the study treatment
  • history of organ transplant
  • Pregnancy or lactating women
  • Use of any other experimental medication within 4 weeks or 5 half-lives prior to start of study drug
  • Use of biologics within 3 months, stem cell transplant or CAR-T within 6 months prior to the start of study drug
  • Received live or attenuated vaccine within 4 weeks of Cycle 1 Day 1
  • Presence of other autoimmune or auto-inflammatory diseases that may affect study assessments, such as rheumatoid arthritis, gout, or active fibromyalgia syndrome.
  • Limited to patients diagnosed with SLE: patients with active neuropsychatric SLE
  • Limited to patients diagnosed with IIM: Severe involvement of respiratory muscles affecting ventilatory function; permanent muscle weakness related to IIM; other inflammatory or non-inflammatory myopathy: inclusion body myositis, infectious myopathy, metabolic myopathy, muscular dystrophy or a family history of muscular dystrophy, drug-induced or endocrine-induced myositis, and juvenile myositis
  • Limited to patients diagnosed with SSc: at risk for scleroderma renal crisis; SSc-associated gastric antral vascular ectasia; Severe gastrointestinal involvement leading to malabsorption or intestinal failure
  • Limited to patients diagnosed with AAV: Central nervous system vasculitis; Alveolar hemorrhage requiring invasive pulmonary ventilation

Trial locations and contacts

2 sites in 1 country. Contact the study team or a site near you to ask about taking part.

Kai Hu contact

+86 150 1039 0336

huk@gobroadhealthcare.com

China2 sites, 2 recruiting

  • Beijing Boren Hospital

    Beijing

    Yajing Zhang, +8618601333856, zhangyj3@gobroadhealthcare.com

    Yajing Zhang

    Recruiting

  • Beijing GoBroad Hospital

    Beijing

    Kai Hu, +86 150 1039 0336, huk@gobroadhealthcare.com

    Kai Hu

    Recruiting

Other trials in China

About this study

Official title: An Open-Label, Phase I Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Allogeneic CAR-T Cell Therapy (OL-108) in the Treatment of Relapsed/Refractory Autoimmune Diseases

This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-108 in relapsed/refractory autoimmune diseases.

Read the detailed description

This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-108 in the treatment of Relapsed/ Refractory Autoimmune Disease such as SLE, IIM, SSc and AAV.

Being tested
OL-108
Medical subject headings
Lupus Erythematosus, Systemic, Myositis, Scleroderma, Systemic, Anti-Neutrophil Cytoplasmic Antibody-Associated Vasculitis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • OL-108Biological

    OL-108 will be given through IV bolus with ascending dose levels to determine the maximum tolerated dose (MTD)

Study groups in NCT06980597
Study groupRoleWhat they receive
OL-108ExperimentalNot described
Receives: Biological: OL-108

What is being measured

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

  1. Dose-limiting toxicity (DLT)

    Adverse events will be assessed based on the CTCAE 5.0

    Measured: After OL-108 administration up to 30 days (Day 1-Day 30)

  2. Treatment emergent adverse event (TEAE) incidence and severity

    Adverse events will be assessed based on the CTCAE 5.0

    Measured: From lymphodepletion through study completion, up to 2 years

Secondary outcomes (7)

  1. Overall Response Rate

    The efficacy outcome variable, Overall Response Rate (ORR), is defined as the ratio between the number of subjects experiencing a response at weeks 12, 24 and 52 and the total number of enrolled subjects.

    A response to treatment will be considered as:

    • SLE: Fulfillment of DORIS remission/LLDAS criteria of SLE.
    • SSc: Fulfillment of mCRISS criteria
    • IIM: 2016 ACR/EULAR Total Improvement Score.
    • AAV: Birmingham vasculitis activity score (BVAS) of 0.

    Measured: Baseline through study completion, up to 2 years

  2. Cmax of OL-108

    The maximum concentration of the CAR-T cells will be measured to assess OL-108 in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  3. Tmax of OL-108

    The time of the maximum concentration will be measured to assess OL-108 in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  4. AUC 0-28 days of OL-108

    Area under the curve will be measured to assess OL-108 in vivo expansion and persistence.

    Measured: Baseline through study completion, up to 2 years

  5. Serum cytokines

    The levels of cytokines will be measured, such as IL-6 and ferritin.

    Measured: From lymphodepletion till day 90

  6. Level of Immunogenicity

    To assess the presence of antibodies to OL-108 (ADA)

    Measured: Baseline through study completion, up to 2 years

  7. Level of RCR

    To determine whether Replication Competent Retrovirus (RCR) is present in patients that receive OL-108

    Measured: Baseline through study completion, up to 2 years

Timeline

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

  1. First posted20 May 2025
  2. Study startJun 2025 (estimated)
  3. Primary completionDec 2027 (estimated)
  4. Study completionDec 2028 (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
44 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06980597
Sponsor's protocol ID
OL-108-001
Status last verified
May 2025
First submitted
12 May 2025
Last updated
20 May 2025
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 OL-108 in people with Systemic Lupus Erythematosus (SLE) and Idiopathic Inflammatory Myopathy (IIM), run by Beijing GoBroad Hospital at 2 sites in China.

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 13 inclusion and 19 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: looking for participants now, as of the sponsor's last update on 20 May 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in China. 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?

Contact Kai Hu (+86 150 1039 0336, huk@gobroadhealthcare.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Dose-limiting toxicity (DLT) (time frame: After OL-108 administration up to 30 days (Day 1-Day 30)). 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 NCT06980597.

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 20 May 2025.

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