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


Phase 1
18 Years
N/A
Open (Enrolling)
Both
Malignant Lymphomas, Solid Tumors

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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

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