Clinical Trials in China / NCT07331272
Recruiting
Phase 1
A Study of LUCAR-G79D in Subjects With Relapsed/Refractory Systemic Lupus Erythematosus (r/r SLE) and Idiopathic Inflammatory Myopathies (r/r IIM)
NCT07331272 · tracked via the Priya Life Science China tracker
Condition(s) studied
Systemic Lupus Erythematosus (SLE)Idiopathic Inflammatory Myopathies(IIM)
Investigational drug(s) / intervention(s)
LUCAR-G79D T cells
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
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 | Nanchang | Jiangxi | Not Yet Recruiting |
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Official registry record
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.
View NCT07331272 on ClinicalTrials.gov ↗ ← All trials in China