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cemacabtagene ansegedleucel

Phase 2

Large B-cell Lymphoma | CAR-T | Oncology |Allogene Therapeutics, Inc.|Trials Updated: Oct 2, 2026

cemacabtagene ansegedleucel development status

Highest phase Phase 2
Registered trials 1 across 1 sponsor since Jul 2024

cemacabtagene ansegedleucel target and mechanism

Molecular targetCD19
Target class-Cel (Cell Tx)
ModalityCAR-T

Also known as cema-cel

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLEDDMC
Total Trials1
Total Enrollment250

FDA Designations

RMATFAST_TRACK

cemacabtagene ansegedleucel clinical trials

cemacabtagene ansegedleucel · 1 trial · 1 indication

Phase 2 1
NCT06500273Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCLLarge B-cell Lymphoma
RECRUITING250 Analytics
PHASE2RECRUITING
Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL
Large B-cell LymphomaUnlock trial analytics

Study Endpoints

Primary Endpoints

Event-free survival per independent review committee assessment
Up to 60 months

Secondary Endpoints

Progression-free survival per independent review committee assessment
Up to 60 months
Overall survival
Up to 60 months
Incidence and severity of adverse events and their relationship to cemacabtagene ansegedleucel and ALLO-647
Up to 60 months
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Study Design & Arms

AllocationRANDOMIZED
MaskingNONE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
cemacabtagene ansegedleucelEXPERIMENTALParticipants receive cemacabtagene ansegedleucel following lymphodepletion regimen comprised of fludarabine and cyclophosphamide.
ObservationOTHERParticipants do not receive any study treatments. They are observed as per the current standard of care.

Interventions

NameTypeDescription
cemacabtagene ansegedleucelGENETICAn allogeneic CAR T cell therapy targeting CD19
FludarabineDRUGChemotherapy for lymphodepletion
CyclophosphamideDRUGChemotherapy for lymphodepletion
Foresight CLARITY™ IUO MRD test, powered by PhasED-Seq™DEVICEA diagnostic test intended to identify patients with minimal residual disease at the end of first line treatment for LBCL.
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites85

Key Inclusion Criteria: 1. LBCL per WHO 2017 including diffuse large B-cell lymphoma, high-grade B-cell lymphoma, and primary mediastinal B-cell lymphoma histologically confirmed by pathology report. 2. Participant has completed a full course of standard first line therapy (e.g., R-CHOP, dose-adjus...

Countries:United StatesAustraliaCanadaSouth Korea
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Recent Changes (Last 90 Days)

LOWOct 2, 2026NCT06500273lastUpdatePostDate: changed
LOWOct 2, 2026NCT06500273lastUpdatePostDate: changed
LOWAug 31, 2026NCT06500273lastUpdatePostDate: changed
LOWAug 31, 2026NCT06500273lastUpdatePostDate: changed
LOWJul 30, 2026NCT06500273lastUpdatePostDate: changed
LOWJul 30, 2026NCT06500273lastUpdatePostDate: changed

Frequently asked questions about cemacabtagene ansegedleucel

What is cemacabtagene ansegedleucel used for?

Cemacabtagene ansegedleucel is an investigational CAR-T cell therapy being studied in large B-cell lymphoma. It is being evaluated as consolidation treatment for patients who achieve a first-line remission but remain positive for minimal residual disease, meaning low levels of cancer cells are still detectable after initial therapy.

What does cemacabtagene ansegedleucel target?

Cemacabtagene ansegedleucel targets CD19, a protein found on the surface of B cells and on most large B-cell lymphoma cells. It is a CAR-T therapy, meaning the patient's own T cells are engineered to recognize and attack cells expressing CD19.

Who is developing cemacabtagene ansegedleucel?

Cemacabtagene ansegedleucel is being developed by Allogene Therapeutics, Inc., which trades on the Nasdaq under the ticker ALLO. The company is running the clinical program for the drug in large B-cell lymphoma.

What phase is cemacabtagene ansegedleucel in?

Cemacabtagene ansegedleucel is in Phase 2 clinical development. It is an investigational therapy and has not been approved by the FDA. The FDA has granted it Regenerative Medicine Advanced Therapy (RMAT) and Fast Track designations.

What clinical trials is cemacabtagene ansegedleucel in?

Cemacabtagene ansegedleucel is being studied in the Phase 2 trial NCT06500273, titled Consolidation of First-Line MRD+ Remission With Cema-cel in Patients With LBCL. The trial is recruiting approximately 250 adults with large B-cell lymphoma across the United States, Australia, Canada, and South Korea.

Is cemacabtagene ansegedleucel the same as cema-cel?

Yes, cema-cel is a shorthand name for cemacabtagene ansegedleucel. Both names refer to the same investigational CD19-directed CAR-T cell therapy being developed by Allogene Therapeutics for large B-cell lymphoma.