A Study of OL-CD19-GDT in Relapsed/ Refractory Autoimmune Diseases
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-CD19-GDT in relapsed/refractory autoimmune diseases.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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-CD19-GDT
Biological/VaccineOL-CD19-GDT will be given through IV bolus with ascending dose levels to determine the RDE and RP2D as specified in the protocol
Treatment groups
44 Participants
are divided into 1 treatment groupGroup A: OL-CD19-GDTExperimental 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-CD19-GDT 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 yearsSecondary 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:\*SSc: Fulfillment of mCRISS criteria \*pSS: Achieving ESSDAI response
Time frame
Baseline through study completion, up to 2 years2
Cmax of OL-CD19-GDT
The maximum concentration of the CAR-T cells will be measured to assess OL-CD19-GDT in vivo expansion and persistence.
Time frame
Baseline through study completion, up to 2 years3
Tmax of OL-CD19-GDT
The time of the maximum concentration will be measured to assess OL-CD19-GDT in vivo expansion and persistence.
Time frame
Baseline through study completion, up to 2 years4
AUC 0-28 days
Area under the curve will be measured to assess OL-CD19-GDT in vivo expansion and persistence.
Time frame
Baseline through study completion, up to 2 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Beijing GoBroad Hospital
Lead sponsor
Overland Therapeutics
Collaborator
Source ClinicalTrials.gov