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Also known as MT-601 dose 200 million cells
MT-601 · 2 trials · 10 indications
Dose-limiting toxicities (DLTs)
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 |
|---|---|---|
| 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. |
| 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 dose 200 million cells | DRUG | MT-601 Dose 200 million cells |
| MT-601 dose 400 million cells | DRUG | MT-601 Dose 400 million cells |
| MT-601 dose 800 million cells | DRUG | MT-601 Dose 800 million cells |
| MT-601 dose 1200 million cells | DRUG | MT-601 Dose 1200 million cells |
| MT-601 | DRUG | Multi-antigen specific CD4+ andCD8+ T cells |
Inclusion Criteria: 1. Informed Consent 2. Age ≥ 18 years 3. ECOG performance status of 0 to 1 4. Cytologically or histologically confirmed, locally advanced, unresectable or metastatic pancreatic adenocarcinoma (pancreatic carcinomas with at least some component of adenocarcinoma included). 5. Mea...
MT-601 is an investigational cell therapy being developed by Marker Therapeutics, Inc. for the treatment of certain cancers, including adult non-Hodgkin lymphoma and pancreatic cancer. It is in Phase 1 clinical development and is not yet approved for commercial use. MT-601 is also referred to as MT-601 dose 200 million cells.
MT-601 is being studied for adult non-Hodgkin lymphoma, including relapsed and refractory cases, and for locally advanced unresectable or metastatic pancreatic cancer. Both are oncology indications. The therapy remains investigational and has not been approved for any use.
MT-601 is being developed by Marker Therapeutics, Inc., a clinical-stage biotechnology company. The company trades on the Nasdaq under the ticker symbol MRKR. Marker Therapeutics is the sponsor of the clinical trials evaluating MT-601 in lymphoma and pancreatic cancer.
MT-601 is in Phase 1 clinical development. It is an investigational therapy and has not received FDA approval. The Phase 1 program includes one active trial in relapsed or refractory lymphoma and one trial in pancreatic cancer that is not yet recruiting.
MT-601 is being evaluated in two Phase 1 trials. NCT05798897 is a recruiting study of MT-601 in patients with relapsed or refractory lymphoma, with an enrollment of 79. NCT06549751 is a not-yet-recruiting study of MT-601 in locally advanced unresectable or metastatic pancreatic cancer, with an enrollment of 38.
Yes. MT-601 dose 200 million cells is an alternative name for MT-601, referring to a specific dose level of the same investigational cell therapy. Both names refer to the product being developed by Marker Therapeutics, Inc. in Phase 1 trials for lymphoma and pancreatic cancer.