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CD123 targeted CAR-NK cells

Phase 1

Acute Myeloid Leukemia | Monoclonal antibody | Oncology |Precision BioSciences, Inc.|Last Updated: Aug 30, 2023

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDBiomarker
Total Trials1
Total Enrollment36

FDA Designations

No designations recorded

Clinical trial landscape

CD123 targeted CAR-NK cells · 1 trial · 4 indications

Phase 1 1
NCT06006403Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell NeoplasmAcute Myeloid Leukemia
RECRUITING36 Analytics
PHASE1RECRUITING
Safety and Efficacy of CD123-targeted CAR-NK for Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm
Acute Myeloid LeukemiaUnlock trial analytics

Study Endpoints

Primary Endpoints

To evaluate the safety of CAR-NK cell preparations in the treatment of Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm[Safety and Tolerability]
1 month

The incidence of adverse events after CD123 CAR-NK cell infusion was assessed by the National Cancer Institute's Common Terminology Criteria for Adverse Events (CTCAE, version 5.0)

To evaluate the efficacy of CAR-NK cell preparations in the treatment of Relapsed/Refractory Acute Myeloid Leukemia or Blastic Plasmacytoid Dendritic Cell Neoplasm[Effectiveness]
1month,3months

Objective response rate at 4W±7D and 3M±7D after CAR-NK infusion (Objective response rate includes CR, CRi)

Secondary Endpoints

AUCS of CD123 CAR-NK cells [Cell dynamics]
3 months
CMAX of CD123 CAR-NK cells [Cell dynamics]
3 months
TMAX of CD123 CAR-NK cells[Cell dynamics]
3 months
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Study Design & Arms

AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Acute Myeloid LeukemiaEXPERIMENTALInfusion of CD123-targeted CAR-NK cells by dose of 1-10x10\^6 cells/kg
Blastic Plasmacytoid Dendritic Cell NeoplasmEXPERIMENTALInfusion of CD123-targeted CAR-NK cells by dose of 1-10x10\^6 cells/kg

Interventions

NameTypeDescription
CD123 targeted CAR-NK cellsBIOLOGICALAdministration method: intravenous infusion; Subjects will receive conditioning therapy by Fludarabine and Cyclophosphamide before cell infusion.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Gender is not limited, age 18-75 years old (including the threshold value); 2. The expression of CD123 in tumor cells was detected by flow cytometry. 3. Patients with relapsed/refractory AML or BPDCN diagnosed with CD123 positive: 1) AML: a. Recurrent: After complete response...

Countries:China
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Frequently asked questions about CD123 targeted CAR-NK cells

What is CD123 targeted CAR-NK cells used for?

CD123 targeted CAR-NK cells is an investigational cell therapy being developed for acute myeloid leukemia (AML). It is also being studied in blastic plasmacytoid dendritic cell neoplasm (BPDCN) and relapsed or refractory leukemia. The therapy is currently in Phase 1 clinical development.

What does CD123 targeted CAR-NK cells target?

CD123 targeted CAR-NK cells targets the CD123 antigen, which is expressed on leukemic cells. The therapy uses natural killer (NK) cells engineered with a chimeric antigen receptor (CAR) to recognize and attack CD123-positive cells. This mechanism is being evaluated in patients with acute myeloid leukemia.

Who is developing CD123 targeted CAR-NK cells?

CD123 targeted CAR-NK cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on NASDAQ under the ticker DTIL. The company is conducting a Phase 1 clinical trial of this investigational therapy for acute myeloid leukemia and related conditions.

What phase is CD123 targeted CAR-NK cells in?

CD123 targeted CAR-NK cells is in Phase 1 clinical development. It is an investigational therapy and has not been approved by regulatory authorities. The ongoing Phase 1 trial is recruiting patients to evaluate the safety and efficacy of the treatment.

What clinical trials is CD123 targeted CAR-NK cells in?

CD123 targeted CAR-NK cells is being studied in a Phase 1 clinical trial registered as NCT06006403. This trial is recruiting patients with relapsed or refractory acute myeloid leukemia or blastic plasmacytoid dendritic cell neoplasm. The study is being conducted in China and aims to enroll 36 participants aged 18 years and older.