Title
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 Lymphoma (NHL [APOLLO])

Description
This study is a Phase 1, multicenter, open-label study designed to evaluate the safety and efficacy of MT-601 in patients with relapsed or refractory Non-Hodgkin lymphoma (NHL) who either received CD19+ chimeric antigen receptor (CAR) T cell therapy or are ineligible for CD19+ CAR T cell therapy. The study will consist of two portions: 1) Dose Escalation (3+3 design) followed by 2) Dose Expansion. The purpose of the Dose Escalation portion of the study is to test safety and tolerability of higher doses of MT-601 up to 400 x 106 cells. 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.

Objective
Primary Objectives:
Dose Escalation
- To assess safety and tolerability of escalating doses of MT-601
- To determine the preliminary recommended phase 2 dose and schedule (RP2DS)

Dose Expansion
- To assess anti-tumor activity of MT-601 based on 2014 Lugano criteria or other disease specific response criteria

Secondary Objectives (Efficacy):
Dose Escalation
- To assess anti-tumor activity of MT-601 based on 2014 Lugano Classification

Dose Expansion
- To further evaluate anti-tumor activity of MT-601 (TTR, PFS and OS) based on 2014 Lugano criteria or other disease specific response criteria
- To assess anti-tumor activity in participants with NHL or HL based on the 2016 modified Lugano criteria for immunomodulatory therapy

Secondary Objectives (Safety):
- To assess safety and tolerability of MT-601

Treatment Experimental: Single Arm Study
Single arm study evaluating MT-601 investigational product at 200 million cells and 400 million cells per dose
Drug: MT-601
Multi-antigen specific CD4+ andCD8+ T cells

Key Eligibility 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).

Patients are eligible to be included in the study only if all of the following criteria apply and the patient, in the judgement of the Investigator, is an appropriate candidate for experimental therapy:



Cytologically or histologically confirmed diagnosis of Non-Hodgkin Lymphoma (in any subtype where CD19+ T cell therapy is approved, e.g., DLBCL, MCL, FL)

Relapsed or refractory to CD19+ CAR T cell therapy or ineligible for CD19+ CAR T cell therapy (includes patients whose BOR of SD following CD19+ CAR T cell therapy).

Patients who have had only BOR of PR to CD19+ CAR T cell therapy may also enroll

Are >/=18 years of age prior to administration of MT-601

Patients must have patient-derived cells available to make MT-601

Karnofsky/Lansky score of >/=70 or performance status of 0 or 1 on the Eastern Cooperative Oncology Group (ECOG) scale

Life expectancy >/=12 weeks

Adequate blood, liver, and renal function



Blood: Hemoglobin >/=7.0 g/dL (can be transfused)

Liver: Bilirubin
Renal: Serum creatinine /=30mL/min



Sexually active patients must be willing to utilize one of the highly effective birth control methods or practice complete abstinence starting from Screening for T cell infusion until 6 months after the last T cell infusion. Male patients who are sexually active must agree to use a condom during this period

At least 4 half-lives or 1 week has passed after administration of prior therapy or bridging therapy

Dose escalation defined as patients whose prior treatment course does not meet precise eligibility criteria but may still be approved upon review by the Sponsor

Applicable Disease Sites
Lymphoma

Participating Institutions
UW Health University Hospital