Non Hodgkin Lymphoma Clinical Trial
Efficacy of MT-601 in Patients With Relapsed/Refractory Lymphoma
This study is a Phase 1multicenter study with a Dose Escalation and Dose Expansion evaluating safety and efficacy of MT-601 administration to patients with Relapsed or Refractory NHL. The 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 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.
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 ≤1.5X upper limit of normal (ULN) (exception of bilirubin elevation due to Gilbert's syndrome); aspartate aminotransferase ≤3X ULN
Renal: Serum creatinine ≤2X ULN or measured or calculated creatinine clearance ≥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
Patients are excluded from the study if any of the following criteria apply:
Clinically significant or severely symptomatic intercurrent infection (e.g. patients with uncontrolled HIV infection or have active HBV/HCV infection)
Pregnant or lactating
Any other issue which, in the opinion of the treating physician, would make the patient ineligible for the study
Taking systemic corticosteroids (exception: physiological doses of steroids allowed)
Autologous or allogeneic HSCT within 1 month
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There are 4 Locations for this study
Duarte California, 91010, United States More Info
Denver Colorado, 80218, United States More Info
Nashville Tennessee, 37203, United States More Info
Austin Texas, 78704, United States More Info
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