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CART123 Cells

Phase 1

Relapsed AML | Monoclonal antibody | Oncology |Novartis AG|Last Updated: Jan 16, 2026

Success Probability

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Market & Valuation

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Trial Design

CONTROLLEDDMCBiomarker
Total Trials1
Total Enrollment12

FDA Designations

No designations recorded

Clinical trial landscape

CART123 Cells · 1 trial · 2 indications

Phase 1 1
NCT06768476CART123 + Ruxolitinib in Relapsed/Refractory AMLRelapsed AML
ACTIVE NOT_RECRUITING12 Analytics
PHASE1ACTIVE NOT_RECRUITING
CART123 + Ruxolitinib in Relapsed/Refractory AML
Relapsed AMLUnlock trial analytics

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 to 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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Frequently asked questions about CART123 Cells

What is CART123 Cells used for?

CART123 Cells is an investigational cell therapy being studied for the treatment of relapsed or refractory acute myeloid leukemia (AML). It is currently in Phase 1 clinical development and is not yet approved by regulatory authorities.

Who makes CART123 Cells?

CART123 Cells is being developed by Novartis AG, a multinational pharmaceutical company traded on the New York Stock Exchange under the ticker symbol NVS.

What phase is CART123 Cells in?

CART123 Cells is in Phase 1 clinical development. It is an investigational therapy, meaning it has not been approved by the FDA or other regulatory agencies and is still undergoing clinical trials to evaluate its safety and efficacy.

What clinical trials is CART123 Cells in?

CART123 Cells is being studied in a Phase 1 clinical trial with the identifier NCT06768476. This trial, titled "CART123 + Ruxolitinib in Relapsed/Refractory AML," is active but not recruiting participants and is being conducted in the United States.

Is CART123 Cells the same as any other drug?

CART123 Cells is a distinct investigational cell therapy product. No alternative names for this drug have been reported in the available clinical trial information.