About the Trial
PK,PD,Safety and Tolerability of Multiple Dose Regimens of MT-3724 With Gemcitabine and Oxaliplatin for the Treatment of Patients With Relapsed/Refractory Diffuse Large B Cell Non-Hodgkin's Lymphoma
This is a multi-center, open-label two-part study evaluating the safety and tolerability of
MT-3724 in combination with GEMOX in relapsed or refractory B-cell Lymphoma patients.
Part 1: (MT-3724 Dose Escalation) Define the maximum tolerated dose (MTD) of MT-3724 in combination with standard treatment of GEMOX
Part 2: (MTD Expansion Cohort) Confirm the safety and tolerability of the MTD of MT-3724 from Part 1 in the MTD Expansion Cohort, where MT-3724 will be given at the MTD in combination with GEMOX. In addition, the PK, PD, immunogenicity and tumor response at the MTD of MT-3724 in combination with GEMOX will be more thoroughly evaluated in Part 2.
MT-3724 will be administered as intravenous (IV) infusion over 1 hour. In C1, MT-3724 infusion should be administered on Days 1, 3, 5, 8, 10, 12, 15, 22, 29, and 36 of the 42-day cycle.
In Cycle 2 and beyond, MT-3724 will be administered weekly on Days 1, 8, 15, and 22 of each 28-day cycle.
During the first 2 weeks of C1, no more than two MT-3724 doses can be administered on consecutive days. If MT-3724 is administered on consecutive days, then at least 20 hours (more than 5 half-lives of MT-3724 in plasma) must elapse between the start of the 2 infusions.
For Weeks 3 through 6 of C1 and for C2 and beyond, different dosing days within ± 2 days from scheduled weekly doses may be selected at investigator's discretion.
Treatment -Gemcitabine 1000 mg/m2 will be administered as 30-minute IV infusion. In C1, Gemcitabine will be administered on Day 16 and Day 30 of the 42-day cycle.
In Cycle 2 and beyond, Gemcitabine will be administered on Day 2 and Day 16 of each 28-day cycle.
Treatment -Oxaliplatin 100 mg/m2 will be administered as 2-hour IV infusion after Gemcitabine. In C1, Oxaliplatin will be administered on Day 16 and Day 30 of the 42-day cycle.
In Cycle 2 and beyond, Oxaliplatin will be administered on Day 2 and Day 16 of each 28-day cycle. Oxaliplatin infusion will start one hour after the start of Gemcitabine infusion (unless a delay is warranted at the investigator's discretion).
Continued Treatment with MT-3724 in combination with GEMOX will continue for four cycles of until death, disease progression, unacceptable toxicity, withdrawal of consent or another reason for withdrawal.
After four cycles, the subjects who experience clinical benefit can continue MT-3724 treatment with additional cycles of 28 days each (either alone or in combination with GEMOX) if supported by the investigator's assessment of the benefit-risk ratio, after consultation with sponsor and Medical Monitor