Trial Information
A Phase I Study of Allogeneic NK Cell Therapy in Patients With Refractory/Relapsed Lymphoma or Solid Tumor
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
Type of Study:
Interventional
Study Design:
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
Outcome Measure:
To determine the MTD of allogenetic NK cells
Outcome Description:
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
Outcome Time Frame:
4-5 weeks
Safety Issue:
Yes
Authority:
Korea: Food and Drug Administration
Study ID:
MG4101_P1
NCT ID:
NCT01212341
Start Date:
September 2010
Completion Date:
November 2011
Related Keywords:
- Malignant Lymphomas
- Solid Tumors
- Allogenetic NK cells
- Lymphomas
- Solid tumors
- Lymphoma
- Neoplasms