Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT07095075 | A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases | EARLY_PHASE1 | RECRUITING | 36 | — | — | Oct 14, 2025 | Dec 31, 2029 | Dec 10, 2025 | 5 | China |
≥Grade 1 clinical symptoms, laboratory test abnormalities, and clinical events that are possibly, likely, or definitely related to study treatment. Accessed by CTCAE5.0.
DLTs are severe adverse events that refers to any untoward medical occurred in a subject participated in a clinical investigation, which have a causal relationship with the treatment and will limit the dose escalation.
CAR positive NK cells in peripheral blood after LUCAR-DKS1 infusion, maximum concentration (Cmax).
CAR positive NK cells levels in peripheral blood after LUCAR-DKS1 infusion, time to Cmax (Tmax).
CAR positive NK cells levels in peripheral blood after LUCAR-DKS1 infusion， area under the concentration-time curve (AUC) .
Recommended phase 2 dose regimen established through dose exploratoration finding.
| Arm | Type | Description |
|---|---|---|
| Chimeric antigen receptor NK cells (LUCAR-DKS1), single-dose for each subject. | EXPERIMENTAL | Experimental: chimeric antigen receptor NK cells (LUCAR-DKS1). Dose level1：25 millions /kg Dose level2：50 millions /kg Dose level3：100 millions /kg Dose level4：200 millions /kg Dose level5：400 millions /kg Totally 5 dose groups, each subject will be given a single-dose LUCAR-DKS1 cells infusion at a certain level, subject will be administered at day 1. |
| Name | Type | Description |
|---|---|---|
| LUCAR-DKS1 NK cells | BIOLOGICAL | Prior to the infusion of the LUCAR-DKS1 cells, subjects will receive a conditioning premedication regimen consisting of cyclophosphamide and fludarabine. |
* Inclusion Criteria: 1. Subjects voluntary agreement to provide written informed consent. 2. Aged 18 to 70 years, either sex. 3. Clinical laboratory values meet screening criteria. 4. Positive test for CD19 and/ or BCMA SLE: * Meets at least 1 classification criteria≥6 months for SLE. * ...