NCT03778619

MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin

Multi-center, Open-label, Phase 1/2a Clinical Trial to Evaluate the Efficacy and Safety of Combination Therapy With MG4101 Plus Rituximab in Patient With Relapsed/Refractory Non-Hodgkin's Lymphoma of B-cell Origin

• Status: Unknown
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 9 (actual)
• Sponsor: GC Cell Corporation · Industry
• Sex: All
• Age: 20 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

To determine the efficacy and safety of combined therapy of determined MG4101 dose and Rituximab.

Detailed description

This trial will consist of 3 parts; Phase 1 Maximum Tolerated Dose, Phase 1 extended cohort and Phase 2a. For Phase 1, those who have a confirmed diagnosis of relapsed/refractory Non-Hodgkin's Lymphoma (NHL) of B-cell Origin of any subtype will be considered eligible for enrolment. Each cycle last approximately 28 days. Once the dose of MG4101 is determined from Phase 1, Phase 2a will commence whereby two subgroups of patients will be enrolled and will similarly receive up to 6 cycles of treatment with the recommended Phase 2a dose of MG4101. The 2 subgroups are patients with indolent and aggressive NHL of B-cell origin respectively.

Conditions

• Relapsed Non Hodgkin Lymphoma
• Refractory Non-Hodgkin Lymphoma

Interventions

Type	Name	Description
DRUG	Rituximab	weekly administration of Rituximab 375mg/m2 during cycle 1 and 2, monthly administration from cycle 3(up to cycle 6)
DRUG	Fludarabine	administration of fludarabine 20mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
DRUG	Cyclophosphamide	administration of fludarabine 250mg/m2 for 3 consecutive days starting at 3 days before the 1st, 3rd, and 5th cycle of the first rituximab infusion for that cycle
BIOLOGICAL	MG4101(allogeneic Natural Killer cell)	administration every fortnight for each cycle, beginning with the 1st dose of rituximab for that cycle.
DRUG	Interleukin-2	1 x 10\^6 IU/m2, together with MG4101

Timeline

• Start date: 2018-11-28
• Primary completion: 2020-04-20
• Completion: 2020-10-30
• First posted: 2018-12-19
• Last updated: 2020-07-28

Locations

3 sites across 1 country: South Korea