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Also known as LUCAR-DKS1 NK cells
LUCAR-DKS1 · 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 is an investigational cell therapy being developed by Legend Biotech Corporation for relapsed or refractory autoimmune diseases. It is in Phase 1 clinical development and has not been approved by the FDA. It is also known as LUCAR-DKS1 NK cells.
LUCAR-DKS1 is being studied for the treatment of relapsed or refractory autoimmune diseases. The single clinical trial of LUCAR-DKS1 enrolls adults aged 18 years and older with these conditions. It is investigational and has not been approved for any indication.
LUCAR-DKS1 is developed by Legend Biotech Corporation, which trades under the ticker LEGN. Legend Biotech is the sponsor of the Phase 1 study evaluating LUCAR-DKS1 in relapsed or refractory autoimmune diseases.
LUCAR-DKS1 is in Phase 1 clinical development. Its only trial is listed as an early Phase 1 study that is currently recruiting. LUCAR-DKS1 has not been approved by the FDA and remains investigational.
LUCAR-DKS1 is being evaluated in one clinical trial, NCT07095075, titled A Study of LUCAR-DKS1 in Subjects With Relapsed/Refractory Autoimmune Diseases. The trial is an early Phase 1, open-label, uncontrolled study recruiting 36 participants in China.
Yes, LUCAR-DKS1 NK cells is another name for LUCAR-DKS1. Both names refer to the same investigational cell therapy developed by Legend Biotech Corporation for relapsed or refractory autoimmune diseases.