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MT-601 · 1 trial · 7 indications
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)
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.
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.
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.
| Arm | Type | Description |
|---|---|---|
| Single Arm Study | EXPERIMENTAL | Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose |
| Name | Type | Description |
|---|---|---|
| MT-601 | DRUG | Multi-antigen specific CD4+ andCD8+ T cells |
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...
MT-601 is an investigational small molecule being developed for the treatment of Non-Hodgkin Lymphoma in adults. It is currently being studied in patients with relapsed or refractory lymphoma, including both Non-Hodgkin and Hodgkin lymphoma subtypes, as part of a Phase 1 clinical trial.
MT-601 is being developed by Marker Therapeutics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MRKR. The company is currently conducting a Phase 1 clinical trial to evaluate the safety and preliminary efficacy of MT-601 in patients with relapsed or refractory lymphoma.
MT-601 is currently in Phase 1 clinical development. It is an investigational drug and has not been approved by the FDA. The ongoing Phase 1 trial is recruiting patients to assess the safety and preliminary efficacy of MT-601 in adults with relapsed or refractory lymphoma.
MT-601 is being evaluated in a single Phase 1 clinical trial with the identifier NCT05798897. The trial, titled 'Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma,' is currently recruiting participants in the United States and aims to enroll 79 patients aged 18 years and older.
MT-601 is a small molecule therapeutic being developed for oncology indications. The specific molecular target of MT-601 has not been disclosed in the available clinical trial information. The ongoing Phase 1 study is focused on evaluating its safety and preliminary efficacy in patients with relapsed or refractory lymphoma.