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Hodgkin Lymphoma

Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose

Multi-antigen specific CD4+ andCD8+ T cells

MT-601

Monic Stuart, MD

Patricia Allison

Geoffrey Shouse, DO, PhD

Luke Mountjoy, DO

Cari Stockard

Haitham Abdelhakim, MD

Erica Swartout

Samuel Yamshon, MD

Ian Flinn, MD, PhD

Ian Flynn, MD, PhD

Aravind Ramakrishnan, MD

Mariah Endres

Priyanka Pophali, MD

This study is a Phase 1 multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory Lymphoma. The starting dose administered is 200 x 10\^6 cells (flat dosing).

This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in participants with relapsed or refractory (R/R) non-Hodgkin lymphoma (NHL) or Hodgkin lymphoma (HL) who either relapsed or had incomplete response after cluster of differentiation (CD) 19-directed chimeric antigen receptor (CAR) T cell therapy or are CAR T cell therapy naïve (ineligible or refused CD19-directed CAR T cell therapy or for whom CAR T cell therapy is not available). The study will consist of two portions or phases: 1) Dose Escalation with allowance for backfilling cohorts (up to 50 participants) followed by 2) Dose Expansion at the preliminary RP2DS in 1-2 disease specific cohorts of up to 29 participants each. The Dose Expansion portion of this study will begin after completion of the Dose Escalation portion. The purpose of the Dose Expansion portion of the study is to evaluate the clinical efficacy of MT-601 at the dose determined to be safe in the Dose Escalation portion.

Safety and Preliminary Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma

A Phase 1 Study of Patient-Derived Multi-Tumor-Associated Antigen-Specific T Cells (MT-601) Administered to Patients With Relapsed or Refractory Non-Hodgkin and Hodgkin Lymphoma (APOLLO)

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.

Spots Global Cancer Trial Database for hodgkin's lymphoma, relapsed, adult