Malignant LymphomasPhase 1MG4101NCT01212341
Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor
A Phase 1 study testing Allogeneic NK cells in people with Malignant Lymphomas and Solid Tumors, run by Seoul National University Hospital at 1 site in South Korea.
Trial summary
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Malignant Lymphomas, Solid Tumors
- What is being tested?
- Allogeneic NK cells
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSouth Korea
- Study dates
- Sep 2010to Mar 2013
- Phase
- Phase 1
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 years or older
- Histologically or cytologically confirmed malignant lymphoma or solid tumor
- After the failure of standard treatment
- KPS >70 or ECOG PS 0-2
- Adequate bone marrow, renal, and liver functions
- Expected survival at least 3 months
- Informed consent
Who cannot join
- Pregnancy or lactating woman
- HIV patients
- Prior exposure to cell-based therapy
- Hypersensitivity to interleukin-2
- Patients with autoimmune disease
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.
- Conditions
- Malignant Lymphomas, Solid Tumors
- Being tested
- Allogeneic NK cells
- Keywords
- Allogenetic NK cells, Lymphomas, Solid tumors
- Medical subject headings
- Lymphoma
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Allogeneic NK cellsBiological
| Study group | Role | What they receive |
|---|---|---|
| Singe-dose infusion | Experimental | Cohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg Receives: Biological: Allogeneic NK cells |
| Repeated dose infusion | Experimental | Cohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg Receives: Biological: Allogeneic NK cells |
What is being measured
The primary outcome is the main question the study is designed to answer.
To determine the MTD of allogenetic NK cells
DLT is defined as follows:
- Any toxicity at grade 3 or over for 5 days or more
- All grade 4 toxicities
- GVHD at grade 2 or over
Measured: 4-5 weeks
Secondary outcomes (3)
To determine the overall response rate
RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma
Measured: 4-5 weeks
To evaluate the safety
NCI-CTCAE v3.0
Measured: 4 -5 weeks
To evaluate the pharmacokinetics of allogeneic NK cells
To quantify the persistence of donor NK cells in recipients
Measured: 4-5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Sep 2010 (estimated)
- Study startSep 2010
- Primary completionAug 2012
- Study completionMar 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Malignant LymphomasStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- GC Biopharma Corp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01212341
- Sponsor's protocol ID
- MG4101_P1
- Acronym
- MG4101
- Status last verified
- Aug 2013
- First submitted
- 18 Sep 2010
- Last updated
- 19 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor
- ClinicalTrials.gov ID
- NCT01212341
- Acronym / sponsor ID
- MG4101 / MG4101_P1
- Conditions
- Malignant Lymphomas, Solid Tumors
- Keywords
- Allogenetic NK cells, Lymphomas, Solid tumors
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Collaborators
- GC Biopharma Corp
- Study start
- Sep 2010
- Primary completion
- Aug 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 30 Sep 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Allogeneic natural killer (NK) cells (MG4101) were manufactured from normal healthy donor who underwent leukapheresis. These cells were processed based on a novel method for ex vivo activation and expansion using an irradiated and activated autologous feeder cell system. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Singe-dose infusion | Experimental | Biological: Allogeneic NK cellsCohort 1: 1x10^6 cells/kg Cohort 2: 1x10^7 cells/kg |
| Repeated dose infusion | Experimental | Biological: Allogeneic NK cellsCohort 3: 1x10^6 cells/kg Cohort 4: 3x10^6 cells/kg Cohort 5: 1x10^7 cells/kg Cohort 6: 3x10^7 cells/kg |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age 18 years or older
- Histologically or cytologically confirmed malignant lymphoma or solid tumor
- After the failure of standard treatment
- KPS >70 or ECOG PS 0-2
- Adequate bone marrow, renal, and liver functions
Key exclusion criteria (5 listed)
- Pregnancy or lactating woman
- HIV patients
- Prior exposure to cell-based therapy
- Hypersensitivity to interleukin-2
- Patients with autoimmune disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Allogeneic NK cells | Biological | Repeated dose infusion, Singe-dose infusion |
Primary outcome
To determine the MTD of allogenetic NK cells
Time frame: 4-5 weeks
DLT is defined as follows: * Any toxicity at grade 3 or over for 5 days or more * All grade 4 toxicities * GVHD at grade 2 or over
3 secondary outcomes
To determine the overall response rate
Time frame: 4-5 weeks
To evaluate the safety
Time frame: 4 -5 weeks
To evaluate the pharmacokinetics of allogeneic NK cells
Time frame: 4-5 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2013.
Related trials for Malignant Lymphomas
Active, not recruitingPhase 2
Brentuximab Vedotin and Combination Chemotherapy in Treating Patients With CD30-Positive Peripheral T-cell Lymphoma
Adult T-Cell Leukemia/Lymphoma, Anaplastic Large Cell Lymphoma, ALK-Negative
RecruitingPhase 1/2
A Platform Trial Evaluating New Drugs or Combination in R/R Peripheral T-cell Lymphomas
Peripheral T Cells Lymphoma (PTCL), Follicular Helper T-Cell Lymphoma
Active, not recruitingPhase 2
Testing AZD5363 as a Potential Targeted Treatment in Cancers With AKT Genetic Changes (MATCH-Subprotocol Y)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
Active, not recruitingPhase 2
Testing GDC-0032 (Taselisib) as a Potential Targeted Treatment in Cancers With PIK3CA Genetic Changes (MATCH-Subprotocol I)
Advanced Lymphoma, Advanced Malignant Solid Neoplasm
RecruitingPhase 2
At-Home Cancer Directed Therapy Versus in Clinic for the Treatment of Patients With Advanced Cancer
Advanced Anal Carcinoma, Advanced Biliary Tract Carcinoma
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Allogeneic NK cells in people with Malignant Lymphomas and Solid Tumors, run by Seoul National University Hospital at 1 site 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 7 inclusion and 5 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: finished, as of the sponsor's last update on 19 Aug 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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 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.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To determine the MTD of allogenetic NK cells (time frame: 4-5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Aug 2013.