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zamtocabtagene autoleucel

Phase 2

B-Cell Neoplasm | Small molecule | Oncology |Thermo Fisher Scientific Inc|Last Updated: May 5, 2026

Target and mechanism

Target class-Cel (Cell Tx)
ModalitySmall molecule

Also known as zamtocabtagene autoleucel (MB-CART2019.1)

Success Probability

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Market & Valuation

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Trial Design

UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment31

FDA Designations

No designations recorded

Clinical trial landscape

zamtocabtagene autoleucel · 1 trial · 1 indication

Phase 2 1
NCT06508931Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell NeoplasmsB-Cell Neoplasm
RECRUITING31 Analytics
PHASE2RECRUITING
Safety and Efficacy Study of Zamtocabtagene Autoleucel (MB-CART2019.1) in Pediatric Patients With R/R B-Cell Neoplasms
B-Cell NeoplasmUnlock trial analytics

Study Endpoints

Primary Endpoints

BORR, Best Overall Response Rate
From infusion until week 78

The primary efficacy outcome of this study is BORR, defined as the proportion of subjects with at least one partial response (PR) or complete response (CR) from MB-CART2019.1 infusion until progressive disease (PD), start of new anti-lymphoma therapy, lost to follow-up or death, whichever occurs first.

Type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) [Safety and toxicity of the study product]
From infusion until week 78

The primary safety outcome of this study is to evaluate the incidence, type, frequency, and severity of adverse events (AEs), serious adverse events (SAEs), and adverse events of special interest (AESI) associated with the study product.

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Study Design & Arms

AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
zamtocabtagene autoleucel (MB-CART2019.1)EXPERIMENTAL -

Interventions

NameTypeDescription
zamtocabtagene autoleucel (MB-CART2019.1)DRUGTandem CD20-CD19-directed non-cryopreserved CAR-T cell therapy.
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Eligibility Criteria

Age Range6 Months to 17 Years
SexALL
Healthy VolunteersNo
Study Sites5

Inclusion Criteria: 1. Is able to provide age-appropriate assent/consent (as applicable, according to local legislation) and/or have a guardian able to provide consent signed and dated by the parent(s) or by subject's legal guardian before conduct of any study-specific procedures. 2. Has histologic...

Countries:FranceGermanyItalyNetherlands
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Frequently asked questions about zamtocabtagene autoleucel

What is zamtocabtagene autoleucel used for?

Zamtocabtagene autoleucel is an investigational cell therapy being studied for the treatment of B-cell neoplasms, specifically in pediatric patients with relapsed or refractory disease. It is currently in Phase 2 clinical development and is not yet approved by regulatory authorities.

What does zamtocabtagene autoleucel target?

Zamtocabtagene autoleucel is a cell therapy, a class of treatment that uses modified cells to fight cancer. Its specific molecular target is not disclosed in available information, but it is being evaluated for its safety and efficacy in B-cell neoplasms.

Who is developing zamtocabtagene autoleucel?

Zamtocabtagene autoleucel is being developed by Thermo Fisher Scientific Inc, a company traded on the New York Stock Exchange under the ticker symbol TMO. The drug is also known as MB-CART2019.1.

What phase is zamtocabtagene autoleucel in?

Zamtocabtagene autoleucel is in Phase 2 clinical development. It is an investigational drug, meaning it has not been approved by the FDA or other regulatory bodies and is still being studied in clinical trials.

What clinical trials is zamtocabtagene autoleucel in?

Zamtocabtagene autoleucel is being studied in a Phase 2 clinical trial with the identifier NCT06508931. This trial is recruiting pediatric patients with relapsed or refractory B-cell neoplasms and is being conducted in France, Germany, Italy, and the Netherlands.

Is zamtocabtagene autoleucel the same as MB-CART2019.1?

Yes, zamtocabtagene autoleucel is also known as MB-CART2019.1. Both names refer to the same investigational cell therapy being developed for the treatment of B-cell neoplasms.