MT-601

Neldaleucel

DEVELOPMENT STEP phase-1

SPONSOR MATRIX Marker Therapeutics [MRKR]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

Relapsed / Refractory Lymphoma, Pancreatic Cancer

Mechanism Abstract

MT-601 is an autologous multi-tumor associated antigen (TAA)-specific T cell immunotherapy product that depending on the patient’s endogenous precursors recognizes cancer cells expressing at least one of the 6 TAAs via native T cell receptors (TCRs), which interact with class I and II major histocompatibility complex (MHC also known as HLA [human leukocyte antigen]) presenting the antigenic peptides. The interaction between TCRs and the tumor antigen epitopes leads to T cell activation, proliferation, and acquisition of effector functions (e.g., secretion of inflammatory cytokines and/or chemokines and cytotoxicity). This sequence of events leads to killing of tumor cells expressing these antigens as well as the activation of other immune cells in the tumor microenvironment.

[3D_INTERACTIVE_CONFORMATION]

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[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED2

RECRUITING STATUS1

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-1NCT06549751

Pancreas CancerPancreatic Cancer Metastatic+1 more

N=38Est. Finish: 2028-09-16

MT-601 Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer

not yet recruiting

ENROLLMENT PATIENT CAPACITY38 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2026-07-16(estimated)

Primary End:2028-07-16(estimated)

Study Finish:2028-09-16(estimated)

OFFICIAL PROTOCOL TITLE

A Phase 1 Study With Expansion of Patient-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-601) Administered To Patients With Locally Advanced Unresectable or Metastatic Pancreatic Cancer (PANACEA)

[INVESTIGATORS_&_FACILITY_ROSTER]

Patricia Allison, BSSTUDY DIRECTOR — Marker Therapeutics

Kaylor HopkinsCONTACT — Marker Therapeutics, Inc.

[PRIMARY_SUCCESS_ENDPOINTS]

During Dose Escalation - determine the MTD, recommended expansion dose, or MPD of MT-601 administered during maintenance capacitabine following treatment with FOLFIRINOX (FFX) or NALIRIFOX (NLX).

Analysis Window: Through study completion. Approximately 24 months

[SECONDARY_SUCCESS_ENDPOINTS]

During Dose Expansion - evaluate the safety profile of MT-601

Analysis Window: Through study completion. Approximately 2.5 years

During Dose Escalation and Dose Expansion - determine the Efficacy of MT-601

Analysis Window: Through study completion. Approximately 2.5 years

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

Cohort 1 / MT-601 dose 400 million cells

EXPERIMENTAL

MT-601 dose 400 million cells

Cohort 3 / MT-601 1200 million cells

EXPERIMENTAL

MT-601 dose 1200 million cells

Cohort 2 / MT-601 800 million cells

EXPERIMENTAL

MT-601 dose 800 million cells

Cohort -1 / MT-601 dose 200 million cells

EXPERIMENTAL

Experimental: Cohort -1 / MT-601 dose 200 million cells

Dose Expansion

EXPERIMENTAL

The Dose Expansion portion will begin after completion of the Dose Escalation portion with recommended dose of MT-601.

[DOSING_&_INTERVENTION_SPECIFICITIES]

MT-601 dose 200 million cellsDRUG

MT-601 Dose 200 million cells

MT-601 dose 400 million cellsDRUG

MT-601 Dose 400 million cells

MT-601 dose 800 million cellsDRUG

MT-601 Dose 800 million cells

MT-601 dose 1200 million cellsDRUG

MT-601 Dose 1200 million cells

➔

P-1NCT05798897

Non-Hodgkin Lymphoma, AdultNon-Hodgkin Lymphoma, Refractory+5 more

N=79Est. Finish: 2028-02-28

Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

recruiting

ENROLLMENT PATIENT CAPACITY79 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2023-01-02(actual)

Primary End:2028-02-28(estimated)

Study Finish:2028-02-28(estimated)

OFFICIAL PROTOCOL TITLE

A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)

[INVESTIGATORS_&_FACILITY_ROSTER]

Geoffrey Shouse, DO, PhDCONTACT — City of Hope

Elizabeth NguyenCONTACT — City of Hope

Manali Kamdar, MDCONTACT — University of Colorado

Celeste CanelCONTACT — University of Colorado

Luke Mountjoy, DOCONTACT — Colorado Blood Cancer Institute (Sarah Cannon)

Mallori BureshCONTACT — Colorado Blood Cancer Institute (Sarah Cannon)

Cari StockardCONTACT — University of Kansas Medical Center

Haitham Abdelhakim, MDPRINCIPAL INVESTIGATOR — University of Kansas Medical Center

Nicole SantosCONTACT — Cornell

Samuel Yamshon, MDPRINCIPAL INVESTIGATOR — Cornell

+6 more registered trial investigators

[PRIMARY_SUCCESS_ENDPOINTS]

Dose Escalation

Analysis Window: After 3 or 6 patients in each dose cohort have been treated with MT-601 and have had the opportunity to be followed for 28 days.

Dose Expansion (ORR)

Analysis Window: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

Dose Expansion (DOR)

Analysis Window: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

Dose Expansion (CR)

Analysis Window: 12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

[SECONDARY_SUCCESS_ENDPOINTS]

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[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

Single Arm Study

EXPERIMENTAL

Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose

[DOSING_&_INTERVENTION_SPECIFICITIES]

MT-601DRUG

Multi-antigen specific CD4+ andCD8+ T cells

[BIOCHEMICAL_STRUCTURE_REGISTRY]

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