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DRUG:

zedenoleucel (MT-401)

i
Other names: MT-401, multi-antigen targeted autologous cytotoxic T cell therapy for AML, MultiTAA T cell therapy for AML
Associations
Trials
Company:
Marker Therap
Drug class:
T lymphocyte replacement
Associations
Trials
3ms
ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Trial completion date: Jul 2027 --> Aug 2024 | Trial primary completion date: Jul 2024 --> Mar 2024
Trial completion date • Trial primary completion date
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zedenoleucel (MT-401)
8ms
ARTEMIS: Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant (clinicaltrials.gov)
P2, N=180, Active, not recruiting, Marker Therapeutics, Inc. | Recruiting --> Active, not recruiting
Enrollment closed
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zedenoleucel (MT-401)
almost2years
Early Results of MT-401 (Zedenoleucel) in Post-Transplant MRD+ aml Patients (ASH 2022)
Interestingly, the tumor antigen composition by RNASeq identified an antigen expression profile that changes over time and inversely correlates with the presence of antigen-specific T cells, demonstrating the interplay of tumor cell immunogenicity and antigen-specific T cells. Conclusion s : The preliminary ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD- indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial.
Clinical • IO biomarker
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NPM1 (Nucleophosmin 1) • CD8 (cluster of differentiation 8) • RUNX1 (RUNX Family Transcription Factor 1) • WT1 (WT1 Transcription Factor) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma)
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NPM1 mutation
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zedenoleucel (MT-401)
2years
AML-109 Preliminary Results of MT-401 in Post-Transplant Measurable Residual Disease Positive (MRD+) Acute Myeloid Leukemia (AML) Patients. (PubMed, Clin Lymphoma Myeloma Leuk)
The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRD-indicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be beneficial.
Journal • IO biomarker
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NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1) • WT1 (WT1 Transcription Factor) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • PRAME (Preferentially Expressed Antigen In Melanoma)
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NPM1 mutation
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zedenoleucel (MT-401)
2years
Preliminary Results of MT-401 in Post-Transplant Measurable Residual Disease Positive (MRD+) Acute Myeloid Leukemia (AML) Patients (SOHO 2022)
The lead-in portion of the ARTEMIS results showed that administration of MT-401 converted MRD+ patients to MRDindicating that early intervention with MT-401 administration at MRD+ stage in post-transplant AML can be benefi cial.
Clinical • IO biomarker
|
NPM1 (Nucleophosmin 1) • RUNX1 (RUNX Family Transcription Factor 1) • WT1 (WT1 Transcription Factor) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • PRAME (Preferentially Expressed Antigen In Melanoma)
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NPM1 mutation
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zedenoleucel (MT-401)
over2years
Safety Lead-In of Ph2 AML Study Results Using Zedenoleucel (ASGCT 2022)
Zedenoleucel (also known as MT-401) is a non-genetically modified allogeneic multi-tumor associated antigen (mTAA)-specific T cell therapy with selectivity to multiple tumor antigens, PRAME, WT1, NY-ESO-1 and Survivin... Zedenoleucel was successfully manufactured using two different reagent vendors and was safely administered to 6 post-transplant AML patients with no DLTs noted. Preliminary evidence of anti-tumor activity with zedenoleucel was observed in the Safety Lead-in portion of the Phase 2 ARTEMIS study which further supports the promising Phase 1 ADSPAM data using mTAA-specific T cells. Specifically, the ARTEMIS results showed that administration of zedenoleucel converted an MRD+ patient to MRD- and suggests that AML patients could potentially benefit from administration of zedenoleucel.
Clinical • IO biomarker
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CD8 (cluster of differentiation 8) • RUNX1 (RUNX Family Transcription Factor 1) • WT1 (WT1 Transcription Factor) • RUNX1T1 (RUNX1 Partner Transcriptional Co-Repressor 1) • BIRC5 (Baculoviral IAP repeat containing 5) • CTAG1B (Cancer/testis antigen 1B) • CD4 (CD4 Molecule) • PRAME (Preferentially Expressed Antigen In Melanoma)
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zedenoleucel (MT-401)