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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
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment30
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06690827Clinical Trial of CD123-targeted CAR-NK Therapy for Relapse/refractory AML or BPDCNPHASE1 RECRUITING 30Nov 13, 2024Oct 30, 2028Nov 15, 20241 China
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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 — 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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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06690827studyFirstPostDate: changed