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MG4101 Plus Rituximab Including Lymphodepletion in Patient With r/r NHL B-cell Origin | Clinical Trials | Clareo Health

UNKNOWNPHASE1/PHASE2

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

NCT03778619•GC Cell Corporation

View on ClinicalTrials.gov

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.

Eligibility

Age

20 - 80 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patients with relapsed or refractory NHL of B-cell origin (mature B cell lymphoma according to WHO)\* who are not considered candidates for intensive anti-lymphoma therapy.
•2. Patients must have received at least 1 prior systemic treatment including anti-CD20 therapy but have received no more than 4 systemic treatments and have:
•1. Relapse/Progression and is not considered as a candidate for autologous stem-cell transplantation or high-dose immuno-chemotherapy with allogenic antibody transplantation.
•2. Or Relapsed/progressed after high-dose immuno-chemotherapy with autologous stem-cell transplantation.
•3. Or Relapsed/progressed after homoplastic stem-cell transplantation performed at least 12 weeks ago from C1V1.
•* For Phase 1 - Any subtype can be enrolled. For Phase 2a - Only below subtype can be enrolled in each group. I. Indolent B-cell NHL: Follicular Lymphoma, Lymphoplasmacytic Lymphoma, Mantle Cell Lymphoma and Marginal Zone Lymphoma II. Aggressive B-cell NHL: Diffuse Large B-cell Lymphoma De novo and Diffuse Large B-cell Lymphoma transformed
•3. According to Positron Emission Tomograph(PET)-CT screening, patients having lesion/nodules ≥1 with major axis longer than 1.5 cm and the boundaries are clearly shown.
•4. Eastern Cooperative Oncology Group score 0 or 1
•5. 20 years or older. Age limit for Phase 1 is 65 and for Phase 2a 80.
•6. Expected lifespan ≥ 3 month
+10 more criteria

Exclusion Criteria

•1. Patients considered appropriate to have stem-cell transplantation after high-dose chemotherapy as salvage therapy.
•2. Patient with Central Nervous System(CNS) lymphoma or any involvement of the CNS.
•3. Patients who had a prior history of another malignancy over the last 5 years.
•4. Patients with impaired organ functions deemed as significant by investigators.
•5. Patients who had prior allogeneic Natural Killer cell treatment.
•6. Chronic or active infectious diseases required to be treated at the time of Investigational Product administration, including Cytomegalovirus(CMV) prophylactic therapy.
•7. Had human immunodeficiency virus (HIV)-positive serology.
•8. HBsAg or Hepatitis B virus(HBV) DNA positive or had Hepatitis C virus(HCV) antibodies
•9. Patients who received anti-CD20 cancer chemotherapy or immunoglobulin within 4 weeks of C1V1.
•10. Patients who received another investigational drug within 4 weeks of C1V1.
+18 more criteria

Locations (3)

Asan Medical Center

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Seoul National Univ. Hospital

Seoul, South Korea

Key Dates

Start Date

November 28, 2018

Primary Completion Date

April 20, 2020

Completion Date

October 30, 2020

Last Updated

July 28, 2020

Enrollment

ACTUAL participants

Conditions

Relapsed Non Hodgkin LymphomaRefractory Non-Hodgkin Lymphoma

Interventions

Rituximab

DRUG

Fludarabine

DRUG

Cyclophosphamide

DRUG

MG4101(allogeneic Natural Killer cell)

BIOLOGICAL

Interleukin-2

DRUG

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: July 28, 2020Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

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