| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT05798897 | Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma | PHASE1 | RECRUITING | 79 | — | — | Jan 2, 2023 | Feb 28, 2028 | Aug 20, 2025 | 7 | United States |
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...