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Anti-CD123 CAR NK cells

Phase 1

AML (Acute Myeloid Leukemia) | Small molecule | Oncology |Precision BioSciences, Inc.|Last Updated: Nov 15, 2024

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30

FDA Designations

No designations recorded

Clinical trial landscape

Anti-CD123 CAR NK cells · 1 trial · 2 indications

Phase 1 1
NCT06690827Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCNAML (Acute Myeloid Leukemia)
RECRUITING30 Analytics
PHASE1RECRUITING
Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN
AML (Acute Myeloid Leukemia)Unlock trial analytics

Study Endpoints

Primary Endpoints

Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
28 dyas

The incidence of adverse events after CAR-NK cell infusion was assessed by CTCAE, version 5.0.

Objective response rate (ORR), including complete response (CR) and partial response (PR), after CAR-NK infusion
1month, 2 months, 3 months
overall survival (OS) after CAR-NK infusion
2 years
Duration of response (DOR) after CAR-NK infusion
2 years
recurrence free survival (RFS) after CAR-NK infusion
2 years
event free survival (EFS) after CAR-NK cells infusion
2 years

Secondary Endpoints

Dose limited toxicity (DLT) rate after CAR-NK infusion
1 month
Cmax of anti-CD123 CAR-NK cells in humans
1 month
Overall response rate (ORR) after anti-CD123 CAR-NK therapy in relapsed/refractory AML and BPDCN patients
1 year
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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
CD123 CAR-NK cellsEXPERIMENTAL -

Interventions

NameTypeDescription
Anti-CD123 CAR NK cellsDRUGEach patient will receive two CAR-NK cell infusions at D0 and D7, and CAR-NK cells need to be controlled within 70 minutes from thawing to infusion completion.
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Eligibility Criteria

Age Range18 Years to 75 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Patients of any gender, aged between 18 and 75 years (inclusive); 2. Positive expression of CD123 on tumor cells detected by flow cytometry; 3. Patients with a confirmed diagnosis of CD123-positive relapsed/refractory AML or BPDCN: (1) For AML patients: * Relapsed refers to...

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

What is Anti-CD123 CAR NK cells used for?

Anti-CD123 CAR NK cells is an investigational cell therapy being studied for the treatment of acute myeloid leukemia (AML). It is also being evaluated for blastic plasmacytoid dendritic cell neoplasm (BPDCN). The therapy is currently in Phase 1 clinical development.

What does Anti-CD123 CAR NK cells target?

Anti-CD123 CAR NK cells targets CD123, a protein 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, which may help treat AML and BPDCN.

Who is developing Anti-CD123 CAR NK cells?

Anti-CD123 CAR NK cells is being developed by Precision BioSciences, Inc., a biopharmaceutical company traded on the Nasdaq under the ticker symbol DTIL. The company is conducting a Phase 1 clinical trial for this investigational therapy.

What phase is Anti-CD123 CAR NK cells in?

Anti-CD123 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 participants to evaluate the therapy's safety and efficacy.

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

Anti-CD123 CAR NK cells is being studied in a Phase 1 clinical trial with the identifier NCT06690827. This trial is recruiting 30 participants with relapsed or refractory AML or BPDCN in China. The study is open to adults aged 18 years and older.

Is Anti-CD123 CAR NK cells the same as CD123-targeted CAR-NK therapy?

Yes, Anti-CD123 CAR NK cells is also referred to as CD123-targeted CAR-NK therapy. The clinical trial NCT06690827 is titled 'Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCN,' confirming the same investigational therapy.