LUCAR-G79D T cells: Prior to infusion of the LUCAR-G79D T cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine.
Study summary
This is a prospective, single-arm, open-label and dose-escalation investigator initialed study to evaluate LUCAR-G79D in adult subjects with r/r SLE and r/r IIM.
Eligibility
Sex
ALL
Min age
18 Years
Max age
70 Years
Healthy volunteers
No
Inclusion Criteria:
1. Subjects voluntary agreement to provide written informed consent.
2. Aged 18 to 70 years, either sex.
3. Adequate organ function meet screening criteria.
4. Positive test for cluster of differentiation antigen 19 (CD19).
SLE:
* Have been diagnosed of SLE at least 6 months before screening.
* At screening, antinuclear antibody, and/or anti-dsDNA antibody, and/or anti-Smith antibody should be positive.
* Fulfill relapsed/refractory SLE conditions.
IIM:
* Have been diagnosed of IIM before screening.
* Positive test for myositis-associated antibodies or myositis-specific antibodies at screening.
* Fulfill relapsed/refractory IIM conditions.
Exclusion Criteria:
1. Active infections such as hepatitis and tuberculosis.
2. Other autoimmune diseases.
3. Serious underlying diseases such as tumor, uncontrolled diabetes.
4. Female subjects who were pregnant, breastfeeding.
5. Those with a history of major organ transplantation.
Primary outcome measure(s)
Incidence, severity, and type of treatment-emergent adverse events (TEAEs) — 2 years after LUCAR-G79D infusion (Day 1)
Incidence of dose-limiting toxicity (DLT) — 2 years after LUCAR-G79D infusion (Day 1)
Maximum concentration (Cmax) in peripheral blood — 2 years after LUCAR-G79D infusion (Day 1)
Time of maximum concentration (Tmax) in peripheral blood — 2 years after LUCAR-G79D infusion (Day 1)
Area under the concentration-time curve (AUC) in peripheral blood — 2 years after LUCAR-G79D infusion (Day 1)
Recommended Dose regimen finding — 2 years after LUCAR-G79D infusion (Day 1)
Trial sites (5)
Facility
City
Region
Status
The Third The People's Hospital of Bengbu
Bengbu
Anhui
Recruiting
Nanfang Hospital
Guangzhou
Guangdong
Not Yet Recruiting
Xiangya Hospital of Central South University
Changsha
Hunan
Not Yet Recruiting
The Affiliated Hospital of Xuzhou Medical University
Xuzhou
Jiangsu
Recruiting
The First Affiliated Hospital of Nanchang University
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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