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UCART123v1.2

Phase 1

Relapsed/Refractory Acute Myeloid Leukemia | Monoclonal antibody | Oncology |Cellectis S.A.|Last Updated: Aug 7, 2025

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
UNCONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment29
FDA Designations
ORPHAN_DRUG
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT03190278Study Evaluating Safety and Efficacy of UCART123v1.2 in Patients With Relapsed/Refractory Acute Myeloid LeukemiaPHASE1 ACTIVE NOT_RECRUITING 29 — — Jun 19, 2017Dec 1, 2025Aug 7, 20258 United States
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Study Endpoints
Primary Endpoints
Incidence of adverse events (AE)/serious adverse events (SAE)/Dose Limiting Toxicities (DLT) [Safety and Tolerability]
24 Months

Safety of UCART123v1.2 - Incidence, nature, and severity of AE and SAEs throughout the study

Dose escalation and expansion part: Occurrence of DLTs
Up to Day 28 post last UCART123v1.2 infusion
Secondary Endpoints
Investigators assessed overall response rate according to the European Leukemia Net (ELN) Response Criteria
At Day 28, Day 56, Day 84, Month 3, Month 6, Month 9, Month 12, Month 15, Month 18, Month 21 and Month 24
Duration of Response
From the date of the initial response to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
Progression Free Survival
From the first day of study treatment to the date of disease progression or death from any cause, whichever occurs first, assessed up to Month 24
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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Dose EscalationEXPERIMENTALUCART123v1.2 tested at several dose levels with different lymphodepletion regimens to establish Maximum Tolerated Dose (MTD) and identify Recommended Phase 2 Dose (RP2D) Dose Expansion: UCART123v1.2 administered at the RP2D determined from the dose escalation phase
Interventions
NameTypeDescription
UCART123v1.2BIOLOGICALAllogeneic engineered T-cells expressing anti-CD123 Chimeric Antigen Receptor Biological/vaccine: CLLS52 A monoclonal antibody that recognizes the CD52 antigen Other Names: Alemtuzumab
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Eligibility Criteria
Age Range18 Years — 65 Years
SexALL
Healthy VolunteersNo
Study Sites8

Main Inclusion Criteria: * Patients with relapsed or primary refractory AML (as defined in World Health Organization \[WHO\] criteria) with ≥5% bone marrow blasts * Patients with CD123+ blast cells (verified by flow cytometry) * Eastern Cooperative Oncology Group Performance Status (ECOG-PS) of ≤1 ...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT03190278primaryCompletionDate: changed
LOWMay 24, 2026NCT03190278studyFirstPostDate: changed