Cytokine Induced Killer Cells as Post-Transplant Immunotherapy Following Allogeneic Hematopoietic Cell Transplantation

Robert Negrin

Status and phase: Unknown; Phase 1

Conditions: Multiple Myeloma; Blood and Marrow Transplant (BMT)

Treatments: Drug: Cytokine Induced Killer Cells

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT00185757

13644 (Other Identifier)

NCT00185757

BMT162

95070

Details and patient eligibility

About

The purpose of the study is to determine if the use of activated T cells can effectively treat relapsed disease following allogeneic hematopoietic cell transplantation without causing GVHD.

Enrollment: 20 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant

• eligible for DLI
• no evidence of GVHD
• stable immunosuppressive regimen
• adequate renal and liver function Exclusion Criteria:- CML patients who have not received DLI, active infections

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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20 participants in 1 patient group

Cytokine-induced Killer Cells

Experimental group

Description:

The first cohort =1X10 7 cf expanded cells/kg. The second cohort = 5x10 7 expanded cells/kg. The second cohort = 1X10 8 expanded cells/kg.

Treatment:

Drug: Cytokine Induced Killer Cells