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CART123 Cells

Phase 1

Relapsed AML | Monoclonal antibody | Other |Novartis AG|Last Updated: Jan 16, 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
CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT06768476CART123 + Ruxolitinib in Relapsed/Refractory AMLPHASE1 ACTIVE NOT_RECRUITING 12Feb 28, 2025Mar 1, 2045Jan 16, 20261 United States
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Study Endpoints
Primary Endpoints
Evaluate the safety of CART123 cells when given in combination with ruxolitinib
15 Years

Type, frequency, severity, and attribution of AEs/SAEs, including the incidence and severity of IEC-associated adverse events.

Secondary Endpoints
Evaluate study feasibility
3 months
Describe preliminary efficacy of CART123 cells given in combination with ruxolitinib
From enrollment to Day 28, post treatment.
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Study Design & Arms
AllocationNON_RANDOMIZED
MaskingNONE
ModelSEQUENTIAL
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Arm A: DL1EXPERIMENTAL* LD Chemo: Day -6 to Day -4 (±1d) * Ruxolitinib: Daily beginning on Day -6 (±1d) through D14 post CART123 infusion. * CART123 Cells: Single infusion on Day 0
Arm A: DL-1EXPERIMENTAL* LD Chemo: Day -6 to Day -4 (±1d) * Ruxolitinib: Daily beginning on Day -6 (±1d) through D14 post CART123 infusion. * CART123 Cells: Single infusion on Day 0
Arm B: DL-1EXPERIMENTAL* LD Chemo: Day -6 (-1d) to Day -2 (-1d) * Venetoclax: Day -6 (-1d) through Day +7 - Day +14 post-CART123 infusion * Ruxolitinib: Daily beginning on Day -1 through Day +7 post CART123 infusion. * CART123 Cells: Single infusion on Day 0
Interventions
NameTypeDescription
CART123 CellsBIOLOGICAL1.3x10\^8 CART123 cells
Ruxolitinib 10 MGDRUGTwice Daily
Ruxolitinib 5 MGDRUGTwice Daily
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Eligibility Criteria
Age Range18 Years — N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * 1\. Signed informed consent form 2. Male or female age ≥ 18 years. 3. Patients with active acute myeloid leukemia (AML) with no available curative treatment options using currently available therapies. This is specifically defined as one of the following: 1. AML that has no...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 24, 2026NCT06768476studyFirstPostDate: changed