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

Phase 1

Completed

• Conditions: Malignant Lymphomas; Solid Tumors
• Interventions: Biological: Allogeneic NK cells

• Registration Number: NCT01212341
• Lead Sponsor: Seoul National University Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-09
• Study First Submitted: 2010-09-18
• Study First Submitted QC: 2010-09-29
• Study First Posted: 2010-09-30
• Primary Completion: 2012-08
• Study Completion: 2013-03
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-15
• Last Update Posted: 2013-08-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Singe-dose infusion	Allogeneic NK cells	Cohort 1: 1x10\^6 cells/kg Cohort 2: 1x10\^7 cells/kg
Repeated dose infusion	Allogeneic NK cells	Cohort 3: 1x10\^6 cells/kg Cohort 4: 3x10\^6 cells/kg Cohort 5: 1x10\^7 cells/kg Cohort 6: 3x10\^7 cells/kg

Primary Outcome Measures

Name	Time	Method
To determine the MTD of allogenetic NK cells	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

Secondary Outcome Measures

Name	Time	Method
To evaluate the safety	4 -5 weeks	NCI-CTCAE v3.0
To evaluate the pharmacokinetics of allogeneic NK cells	4-5 weeks	To quantify the persistence of donor NK cells in recipients
To determine the overall response rate	4-5 weeks	RECIST v1.1 for solid tumor or revised response criteria for malignant lymphoma

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of