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CD33/CLL1 dual CAR-NK cell

Phase 1

AML, Adult | Small molecule | Other |China Pharma Holdings, Inc.|Last Updated: Feb 11, 2026

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
CONTROLLEDBiomarker
Total Trials1
Total Enrollment2
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05987696Natural Killer(NK) Cell Therapy in Acute Myeloid LeukemiaPHASE1 COMPLETED 2 — — Jul 31, 2023Jan 17, 2025Feb 11, 20261 China
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Study Endpoints
Primary Endpoints
Incidence of Treatment-Emergent Adverse Events [Safety and Tolerability]
28 Days from first dose of iPSC NK cell infusion
Incidence of subjects with Dose Limiting Toxicities within each dose level cohort
28 Days from first dose of iPSC NK cell infusion
Secondary Endpoints
Overall Response Rate(ORR)
Up to approximately 2 years after last dose of iPSC NK cell infusion
MRD negative rate
28 Days from first dose of iPSC NK cell infusion
Event-free survival
Up to approximately 2 years after last dose of iPSC NK cell infusion]
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
CD33/CLL1 dual CAR-NK cellEXPERIMENTALCLL1/CD33 dual CAR-NK cell therapy in Adult subjects with r/r AML
CD33 CAR-NK cellEXPERIMENTALCD33 CAR-NK cell therapy in Adult subjects with r/r AML
super NK cellEXPERIMENTALsuper NK cell therapy in Adult subjects with AML MRD
Interventions
NameTypeDescription
CD33/CLL1 dual CAR-NK cellDRUGNK cell therapy
CyclophosphamidDRUGLympho-conditioning Agent
FludarabineDRUGLympho-conditioning Agent
CytarabineDRUGLympho-conditioning Agent
CD33 CAR-NK cellDRUGNK cell therapy
super NK cellDRUGNK cell therapy
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: 1. Provision of signed and dated informed consent form (ICF). 2. ≥18 years old. 3. Eastern Cooperative Oncology Group (ECOG) performance status ≤1 and life expectancy greater than 12 weeks. 4. Diagnosis of r/r AML (Cohort 1 and 2) or AML MRD (Cohort 3). 5. Cohort 1: Both CLL1 an...

Countries:China
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