MT-401

Zedenoleucel

DEVELOPMENT STEP phase-1

SPONSOR MATRIX Marker Therapeutics [MRKR]

MECHANISM TARGET // UNMAPPED_TARGET

[THERAPEUTIC_PROFILE]

Target Indications

Acute Myeloid Leukemia

[3D_INTERACTIVE_CONFORMATION]

 // NO_VALID_STRUCTURAL_ASSET_IDENTIFIERS 

[CLINICAL_TRIALS_REGISTRY]

TOTAL EXTRACTED2

RECRUITING STATUS1

COMPLETED RUNS0

REGISTRY & PHASE

TESTED CONDITION

STUDY TITLE & LIFECYCLE TIMELINES

STATUS

➔

P-2NCT04511130

Acute Myeloid LeukemiaStem Cell Transplantation

N=92Est. Finish: 2024-03-01

Efficacy of MT-401 in Patients With AML Following Stem Cell Transplant

terminated

ENROLLMENT PATIENT CAPACITY92 Patients(actual)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2020-10-14(actual)

Primary End:2024-03-01(actual)

Study Finish:2024-03-01(actual)

OFFICIAL PROTOCOL TITLE

A Phase 2 Study of Donor-Derived Multi-Tumor-Associated Antigen Specific T Cells (MT-401) Administered to Patients With Acute Myeloid Leukemia (AML) Following Hematopoietic Stem Cell Transplantation

[INVESTIGATORS_&_FACILITY_ROSTER]

Nishan Rajakumaraswamy, MDSTUDY DIRECTOR — Marker Therapeutics

[PRIMARY_SUCCESS_ENDPOINTS]

Safety Lead-In

Analysis Window: Baseline through Cycle 1 (28 Days)

Phase 2 Adjuvant Group

Analysis Window: Up to 24 months after the first participant is randomized

Phase 2 Active Disease Group

Analysis Window: Up to 12 months

Phase 2 Active Disease Group

Analysis Window: Up to 24 months

[SECONDARY_SUCCESS_ENDPOINTS]

// NO_EXPLICIT_SECONDARY_OUTCOMES_DUMPED

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

MT-401 following HSCT

EXPERIMENTAL

Treatment with MT-401 at 90 days following HSCT

Standard of Care following HSCT

NO_INTERVENTION

Standard of Care

MT-401 following relapse

EXPERIMENTAL

Treatment with MT-401 following relapse after first HSCT

[DOSING_&_INTERVENTION_SPECIFICITIES]

MT-401DRUG

MT-401 (zedenoleucel) is an allogeneic multi-tumor-associated antigen (MultiTAA)-specific T cell product manufactured under Good Manufacturing Practice (GMP) using donor-derived T cells obtained from apheresis.

➔

P-1NCT06552416

Acute Myeloid Leukemia, in RelapseMDS

N=40Est. Finish: 2029-09

Safety of MT-401-OTS in Patients With Relapsed AML or MDS

recruiting

ENROLLMENT PATIENT CAPACITY40 Patients(estimated)

ESTIMATED RUN COMPLETION MILESTONES

Start Date:2025-06-16(actual)

Primary End:2029-09(estimated)

Study Finish:2029-09(estimated)

OFFICIAL PROTOCOL TITLE

A Phase 1 Study of Allogenic Off-the-Shelf Multi-Tumor-Associated Antigen-Specific T Cell Products (MT-401-OTS) Administered to Patients With Relapsed Acute Myeloid Leukemia or Myelodysplastic Syndromes (RAPID)

[INVESTIGATORS_&_FACILITY_ROSTER]

Stephanie KastenCONTACT — City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)

Shukaib Arslan, MDPRINCIPAL INVESTIGATOR — City of Hope Center (City of Hope National Medical Center, City of Hope Medical Center)

Sarah StarrCONTACT — Moffitt Cancer Center

Nelli BejanyanPRINCIPAL INVESTIGATOR — Moffitt Cancer Center

Rafaela NelsonCONTACT — KU Cancer Center

Haitham AbdelhakimPRINCIPAL INVESTIGATOR — KU Cancer Center

Patricia Allison, BSCONTACT — Marker Therapeutics, Inc.

Beth Lepping, BSNCONTACT — Marker Therapeutics, Inc.

[PRIMARY_SUCCESS_ENDPOINTS]

Safety of MT-401-OTS

Analysis Window: Through study completion. Approximately 5 years

Tolerability of MT-401-OTS

Analysis Window: Through study completion. Approximately 5 years

[SECONDARY_SUCCESS_ENDPOINTS]

To assess the efficacy of MT-401-OTS in participants with high-risk or very-high-risk MDS per IPSS-M who have evidence of disease following at least 4 cycles of a HMA

Analysis Window: Following conclusion of the disease assessment of last MDS subject treated. Approximately 2 years

To assess the efficacy of MT-401-OTS in participants with intermediate or high-risk AML per 2022 ELN criteria who have evidence of disease following induction therapy or at least 4 cycles of nonintensive treatment

Analysis Window: Following conclusion of the disease assessment of last AML subject treated. Approximately 2 years

[COHORT_ARMS_ARCHITECTURE_BREAKDOWN]

Cohort -1

EXPERIMENTAL

50 × 106 cells flat dose, 1 dose infused on Day 0

Cohort 1

EXPERIMENTAL

100 × 106 cells flat dose, 1 dose infused on Day 0

Cohort 2

EXPERIMENTAL

200 × 106 cells flat dose, 1 dose infused on Day 0

Cohort 3

EXPERIMENTAL

400 × 106 cells flat dose, 1 dose infused on Day 0

Cohort 4 (optional)

EXPERIMENTAL

up to 400 × 106 cells flat dose TBD based on data from Cohorts 1-3; may include split dosing, dosing with or without lymphodepleting conditioning regimen, or dosing with or without HMA

[DOSING_&_INTERVENTION_SPECIFICITIES]

MT-401-OTSDRUG

MT-401-OTS is an off the shelf cellular therapy product given by IV infusion through either a peripheral or central line.

[BIOCHEMICAL_STRUCTURE_REGISTRY]

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