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Relapsed Non Hodgkin LymphomaPhase 1/2NCT03778619

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

A Phase 1/2 study testing Rituximab, Fludarabine and Cyclophosphamide in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by GC Cell Corporation at 3 sites in South Korea.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

To determine the efficacy and safety of combined therapy of determined MG4101 dose and Rituximab. Read more about this study

Who is it for?
Ages 20 to 80 years
What is being tested?
Rituximab, Fludarabine and Cyclophosphamide
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
9 participants
Where
3 sitesSouth Korea
Study dates
28 Nov 2018to 30 Oct 2020
Phase
Phase 1/2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
  • 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:
  • Relapse/Progression and is not considered as a candidate for autologous stem-cell transplantation or high-dose immuno-chemotherapy with allogenic antibody transplantation.
  • Or Relapsed/progressed after high-dose immuno-chemotherapy with autologous stem-cell transplantation.
  • 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
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  • 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.
  • Eastern Cooperative Oncology Group score 0 or 1
  • 20 years or older. Age limit for Phase 1 is 65 and for Phase 2a 80.
  • Expected lifespan ≥ 3 month
  • Patients signed Informed consent form
  • Earlier documented result that showed that the patient is positive for CD20 via immunophenotyping within 6 months of C1V1
  • Toxicities due to prior therapy must be stable and recovered to ≤ Grade 1 (except for clinically non-significant toxicities such as alopecia)
  • Those patients who satisfied with following criteria in blood testing, kidney function test and liver function test:
  • Absolute neutrophil count: Absolute Neutrophil Count ≥ 1,000/ µL (Growth factor support at least 2 weeks prior to C1V1)
  • Haemoglobin level ≥ 8g/㎗ (Blood transfusion at least 2 weeks prior to C1V1)
  • Platelet count ≥75,000/µL (Growth factor support/blood transfusion at least 2 weeks prior to C1V1)
  • Total bilirubin < 3.0㎎/㎗
  • Aspartate aminotransferase(AST) or Alanine Aminotransferase(ALT) ≤ 2.5 x upper normal limit (UNL)
  • Creatinine clearance (as estimated by Cockcroft Gault) ≥ 30 mL/min

Who cannot join

  • Patients considered appropriate to have stem-cell transplantation after high-dose chemotherapy as salvage therapy.
  • Patient with Central Nervous System(CNS) lymphoma or any involvement of the CNS.
  • Patients who had a prior history of another malignancy over the last 5 years.
  • Patients with impaired organ functions deemed as significant by investigators.
  • Patients who had prior allogeneic Natural Killer cell treatment.
  • Chronic or active infectious diseases required to be treated at the time of Investigational Product administration, including Cytomegalovirus(CMV) prophylactic therapy.
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  • Had human immunodeficiency virus (HIV)-positive serology.
  • HBsAg or Hepatitis B virus(HBV) DNA positive or had Hepatitis C virus(HCV) antibodies
  • Patients who received anti-CD20 cancer chemotherapy or immunoglobulin within 4 weeks of C1V1.
  • Patients who received another investigational drug within 4 weeks of C1V1.
  • Patients with acute graft-versus-host disease(GvHD) ≥Grade 3 or extensive chronic GvHD within 2 weeks of C1V1.
  • High-dose stem cell support treatment carried out within 6 months of C1V1.
  • Radioimmunotherapy within 4 weeks of C1V1.
  • Patients with major surgery within 4 weeks of C1V1.
  • Patients required to have treatment as having severe diseases such as severe heart failure or uncontrolled severe heart disease and considered not to be appropriate to participate in this trial by investigator's decision.
  • Patients on enzyme inducing agents.
  • Patients who have a plan to have vaccination during the trial.
  • Patients with sensitivity to Interleukin-2, cyclophosphamide or fludarabine.
  • Patients with urinary outflow obstruction
  • Patients with history of abnormal cardiac or pulmonary function tests in 6 months prior to screening visit (Clinically Significant)
  • Patients with history of solid organ allografts
  • Patients with pre-existing or initial presentation of autoimmune disease or inflammatory disorders, such as Crohn's disease, scleroderma, thyroiditis, inflammatory arthritis, diabetes mellitus, oculo-bulbar myasthenia gravis, crescentic Immunoglobulin A(IgA) glomerulonephritis, cholecystitis, cerebral vasculitis, Stevens-Johnson syndrome and bullous pemphigoid, due to possible exacerbation with IL-2
  • Concomitant treatment with other cardiotoxic inducing agents
  • Patients who are allergic to Rituximab, Rituximab's excipient (sodium citrate, polysorbate 80, sodium chloride, sodium hydroxide, hydrochloric acid) or other proteins same as Rituximab.
  • From the day of participation of this trial to 12 months from the day of final administration of Investigational Product, patients who are unable or unwilling to use appropriate contraceptive methods. (Condom, diaphragm, Intrauterine Device, hormonal oral contraceptive use, or male partner with vasectomy)
  • Pregnant or lactating women. (Breast-feeding cannot be done within 12 months after final Investigational Product administration)
  • Patients suspected to have currently known or suspected alcohol abuse or drug abuse according to investigator's decision.
  • According to investigator's judgement, protocols cannot be followed.

Trial locations and contacts

3 sites in 1 country.

South Korea3 sites

  • Asan Medical Center

    Seoul

  • Samsung Medical Center

    Seoul

  • Seoul National Univ. Hospital

    Seoul

Other trials in South Korea

About this study

Official title: 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

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

Read the 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.

Being tested
Rituximab, Fludarabine, Cyclophosphamide, MG4101(allogeneic Natural Killer cell), Interleukin-2
Medical subject headings
Lymphoma, Non-Hodgkin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • RituximabDrug

    Also called Mabthera

    weekly administration of Rituximab 375mg/m2 during cycle 1 and 2, monthly administration from cycle 3(up to cycle 6)

  • FludarabineDrug

    Also called Fludara

    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

  • CyclophosphamideDrug

    Also called Endoxan

    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

  • MG4101(allogeneic Natural Killer cell)Biological

    administration every fortnight for each cycle, beginning with the 1st dose of rituximab for that cycle.

  • Interleukin-2Drug

    Also called proleukin

    1 x 10^6 IU/m2, together with MG4101

Study groups in NCT03778619
Study groupRoleWhat they receive
single armExperimental1. Phase 1 1. MG4101 (Allogeneic Natural Killer cell): i.v bi-weekly * Group 1: 1 x 10^7 cells/㎏ * Group 2: 3 x 10^7 cells/㎏ * Group 3: 9 x 10^7 cells/㎏ 2. Interleukin-2 (IL-2): s.c bi-weekly with MG4101 at 1X10^6 IU/m2 per day. 3. Rituximab: 375mg/m2. i.v. weekly for the first 2 cycles only (8 doses). monthly (3-6 cycle) 4. Lymphodepletion: Fludarabine 20mg/m2 + Cyclophosphamide 250 mg/m2 i.v. D-3, D-2, D-1 of 1st, 3rd, and 5th cycle 2. Phase 2a Administration of recommended dosage of MG4101 determined from Phase 1 will be applied in Phase 2a. Dosage regimens for lymphodepletion, IL-2 and Rituximab will be the same as Phase 1.
Receives: Drug: Rituximab; Drug: Fludarabine; Drug: Cyclophosphamide; Biological: MG4101(allogeneic Natural Killer cell); Drug: Interleukin-2

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Phase I - Maximum Tolerated Dose of the dose of MG4101 in combination with Rituximab

    Dose-Limiting Toxicity assessment

    Measured: 28 days

  2. Phase II - Objective Response Rate

    central review by Positron Emission Tomograph-CT

    Measured: up to 3 years

Secondary outcomes (6)

  1. Phase I - Objective Response Rate

    investigator review by Positron Emission Tomograph-CT

    Measured: 1 years

  2. Phase II - Complete Response

    Complete Response Rate

    Measured: up to 3 years

  3. Phase II -Partial Response

    Partial Response rate

    Measured: up to 3 years

  4. Phase II - Overall Survival

    every 12 weeks after End Of Treatment

    Measured: up to 3 years

  5. Phase II - Time To Progression

    every 12 weeks after End Of Treatment

    Measured: up to 3 years

  6. Phase II - Time to Response

    every 12 weeks after End Of Treatment

    Measured: up to 3 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Dec 2018
  2. Study start28 Nov 2018
  3. Primary completion20 Apr 2020
  4. Study completion30 Oct 2020 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 1/2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
9 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03778619
Sponsor's protocol ID
MG4101-NHL-P1
Status last verified
Jul 2020
First submitted
7 Nov 2018
Last updated
28 Jul 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Rituximab, Fludarabine and Cyclophosphamide in people with Relapsed Non Hodgkin Lymphoma and Refractory Non-Hodgkin Lymphoma, run by GC Cell Corporation at 3 sites in South Korea.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 20 inclusion and 28 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 28 Jul 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Phase I - Maximum Tolerated Dose of the dose of MG4101 in combination with Rituximab (time frame: 28 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03778619.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jul 2020.

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