Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
LUCAR-DKS1 NK cells · 1 trial · 1 indication
≥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. * ...
LUCAR-DKS1 NK cells is an investigational cell therapy being developed for relapsed/refractory autoimmune diseases. It is currently in early Phase 1 clinical development and has not been approved by any regulatory authority.
LUCAR-DKS1 NK cells is being developed by Legend Biotech Corporation, which trades on the NASDAQ under the ticker LEGN. The company is conducting a Phase 1 trial of this investigational therapy in China.
LUCAR-DKS1 NK cells is in early Phase 1 clinical development. It is an investigational therapy and has not been approved for commercial use. A Phase 1 trial is currently recruiting participants in China.
LUCAR-DKS1 NK cells is being studied in a single early Phase 1 trial with the identifier NCT07095075. This open-label, uncontrolled study is recruiting 36 participants with relapsed/refractory autoimmune diseases in China.
LUCAR-DKS1 NK cells is not FDA approved. It is an investigational therapy currently in early Phase 1 clinical development, and its safety and efficacy have not been established.