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

NCT03778619 · Status: UNKNOWN · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 9

Last updated 2020-07-28

No results posted yet for this study

Summary

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

Conditions

  • Relapsed Non Hodgkin Lymphoma
  • Refractory Non-Hodgkin Lymphoma

Interventions

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

Sponsors & Collaborators

  • GC Cell Corporation

    lead INDUSTRY

Principal Investigators

  • Won Seog Kim, Dr. · Samsung Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
20 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-11-28
Primary Completion
2020-04-20
Completion
2020-10-30

Countries

  • South Korea

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03778619 on ClinicalTrials.gov