MT-601 for Relapsed/Refractory Lymphoma
This study is testing a new treatment called MT-601 for people with lymphoma that has come back (relapsed) or hasn't responded to other treatments (refractory). MT-601 is a type of cell therapy using your own immune cells (CD4+ and CD8+ T cells) to fight the cancer. The study aims to find out how safe MT-601 is and if it helps treat lymphoma. You could be eligible if you are 18 to 100 years old and have non-Hodgkin lymphoma or Hodgkin lymphoma. The study will look at how many people respond to the treatment and how long that response lasts. The current recruitment status is unclear, but the study plans to enroll up to 79 participants.
- Study design
- This is a Phase 1, multicenter, open-label study with two parts: Dose Escalation and Dose Expansion. It plans to enroll up to 79 participants.
- What's involved
- Not specified in the trial record.
- Compensation
- Not stated in the trial record.
- Follow-up
- Participants will be followed for at least 12 months after receiving the first dose of MT-601 to assess treatment response.
AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.
Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
At a glance
Conditions
Where it's being run
7 sites across 6 statesWho to contact
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Do you actually qualify for this trial?
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Exclusion
What this trial measures
- Dose EscalationAfter 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.