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MT-601

Phase 1

Non-Hodgkin Lymphoma, Adult | Small molecule | Oncology |Marker Therapeutics, Inc.|Last Updated: Aug 20, 2025

Success Probability
Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
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Market & Valuation
rNPV $3.2B
Market Size $9.4B
Revenue Basis $1.6B
Competitors 6
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Trial Design
UNCONTROLLEDBiomarker
Total Trials1
Total Enrollment79
FDA Designations
No designations recorded
Clinical Trials (1)
NCT IDTitlePhaseStatusEnrollmentVelocityDesignStartCompletionLast UpdatedSitesCountries
NCT05798897Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory LymphomaPHASE1 RECRUITING 79Jan 2, 2023Feb 28, 2028Aug 20, 20257 United States
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Study Endpoints
Primary Endpoints
Dose Escalation
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.

To assess safety and tolerability of escalating doses of MT-601 by the number of participants with MT-601 Dose Limiting Toxicities (DLTs) and Safety events (including but not limited to): treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), deaths, and clinical laboratory abnormalities per National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE, Version 5.0)

Dose Expansion (ORR)
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Objective response rate (ORR) defined as the proportion of treated patients who achieve a best response of complete remission (CR) or partial response (PR) per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for ORR.

Dose Expansion (DOR)
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Duration of response (DOR) defined for patients who attain a best response of CR or PR and is the time between the date of first documented CR or PR and the date of the first observed progression per Lugano Classification. * DOR will be estimated using the Kaplan-Meier (KM) product limit method. The median DOR and corresponding 95% confidence intervals (CI) will be estimated.

Dose Expansion (CR)
12 months after the last patient treated in the Dose Expansion portion of the study receiving the first dose of MT-601.

To assess anti-tumor activity of MT-601 based on Lugano Classification by the following endpoints: * Complete remission (CR) rate defined as the proportion of treated patients who achieve a best response of CR per Lugano Classification. * The Clopper-Pearson method will be used to estimate the two-sided exact 95% confidence interval for CR rate estimates.

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Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
Single Arm StudyEXPERIMENTALSingle arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose
Interventions
NameTypeDescription
MT-601DRUGMulti-antigen specific CD4+ andCD8+ T cells
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Eligibility Criteria
Age Range18 Years — 100 Years
SexALL
Healthy VolunteersNo
Study Sites7

Inclusion Criteria: * All applicable inclusion and exclusion criteria must be met at Screening and at Baseline (re-assessment of eligibility within 14 days prior to group assignment). Participants are eligible to be included in the study only if all of the following criteria apply and the particip...

Countries:United States
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Recent Changes (Last 90 Days)
LOWMay 26, 2026NCT05798897primaryCompletionDate: changed
LOWMay 24, 2026NCT05798897studyFirstPostDate: changed