Allogeneic Natural Killer (NK) Cell Therapy in Patients With Lymphoma or Solid Tumor

Solid Tumors Clinical Trial

— MG4101  

Official title:

A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01212341
• Other study ID #: MG4101_P1
• Status: Completed
• Phase: Phase 1
• First received: September 18, 2010
• Last updated: August 15, 2013
• Start date: September 2010
• Est. completion date: March 2013

Study information

• Verified date: August 2013
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Interventional

Clinical 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. MG4101 has anti-tumor activities against various tumors including malignant lymphomas in vitro as well as in vivo tumor model.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: March 2013
• Est. primary completion date: August 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• Pregnancy or lactating woman

• HIV patients

• Prior exposure to cell-based therapy

• Hypersensitivity to interleukin-2

• Patients with autoimmune disease

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Lymphoma
• Malignant Lymphomas
• Solid Tumors

Intervention

Biological:
• Allogeneic NK cells

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (2)

Lead Sponsor	Collaborator
Seoul National University Hospital	Green Cross Corporation

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4-5 weeks	Yes
Secondary	To determine the overall response rate	RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma	4-5 weeks	No
Secondary	To evaluate the safety	NCI-CTCAE v3.0	4 -5 weeks	Yes
Secondary	To evaluate the pharmacokinetics of allogeneic NK cells	To quantify the persistence of donor NK cells in recipients	4-5 weeks	No