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

ConditionsSystemic Lupus Erythematosus (SLE)Idiopathic Inflammatory Myopathy (IIM)Systemic Sclerosis (SSc)ANCA Associated Vasculitis (AAV)
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing GoBroad Hospital

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Single group

Treatments tested in this trial

  • OL-108

    Biological/Vaccine

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

Treatment groups

44 Participants
are divided into 1 treatment group
Group A: OL-108Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

Dose-limiting toxicity (DLT)

Adverse events will be assessed based on the CTCAE 5.0

Time frame
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

Time frame
From lymphodepletion through study completion, up to 2 years

Secondary outcomes

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.

Time frame
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.

Time frame
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.

Time frame
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.

Time frame
Baseline through study completion, up to 2 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Beijing GoBroad Hospital

Lead sponsor

Source ClinicalTrials.gov
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