This study aims to characterize the safety, tolerability, pharmacokinetics, and preliminary efficacy of OL-CD19-GDT in relapsed/refractory autoimmune diseases.
This is an open-label, single-arm, clinical study to evaluate the efficacy and safety of CAR-T therapy OL-CD19-GDT in the treatment of Relapsed/ Refractory Autoimmune Diseases such as SSc and pSS.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
44
OL-CD19-GDT will be given through IV bolus with ascending dose levels to determine the RDE and RP2D as specified in the protocol
Beijing GoBroad Hospital
Beijing, China
RECRUITINGDose-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)
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
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 years
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 years
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 years
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 years
Serum cytokines
The levels of cytokines will be measured, such as IL-6.
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Time frame: From lymphodepletion till day 90
Level of Immunogenicity
To assess the presence of antibodies to OL-CD19-GDT (ADA)
Time frame: Baseline through study completion, up to 2 years
Level of RCR
To determine whether Replication Competent Retrovirus (RCR) is present in patients that receive OL-CD19-GDT
Time frame: Baseline through study completion, up to 2 years