Blood and Marrow Transplant (BMT), Multiple Myeloma
Conditions
Brief summary
This is a phase 1 dose escalation study evaluating the use of activated T-cells to treat relapsed malignancy (cancer) following allogeneic hematopoietic cell transplantation, without causing GvHD.
Detailed description
This study did not advance to dose expansion.
Interventions
CIK cell dose escalation will be performed in cohorts of three patients per group. The initial dose utilized will be 1x107 expanded cells/kg. Previously, unmanipulated donor lymphocytes administered at this dose did not result in significant GVHD 7. The expansion of the CIK cell population is expected to diminish the T cell subsets responsible for GVHD further reducing the risk of GVHD to recipients. The dose will be increased to 5x107 expanded cells/kg and 1x108 expanded cells/kg in successive escalations based on no significant infusional toxicity or GVHD in the recipients
Sponsors
Stanford University
National Institutes of Health (NIH)
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine the feasibility of expanding allogeneic cytokine induced killer cells suitable for clinical application using a continuous perfusion culture system. | 21 to 28days before infusion |
| To determine the infusional toxicity of ex vivo expanded allogeneic CIK cells in patients with recurrent or refractory disease following allogeneic hematopoietic cell transplantation. | day of infusion up to 24 hours after infusion |
| To determine the incidence of Graft-versus-Host Disease (GVHD) following infusion of allogeneic CIK cells. | first 100 days after infusion |
| To determine the maximum tolerated dose (MTD) of expanded CIK cells for infusion. | day plus 100 after infusion |
Secondary
| Measure | Time frame |
|---|---|
| o determine the incidence of disease response following treatment with allogeneic CIK cells. | one year |
| To assess donor-specific chimerism before and after treatment with allogeneic CIK cells. | 3 months |
| To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system. | 21-28 days |
Countries
United States
Contacts
PRINCIPAL_INVESTIGATORRobert S Negrin
Stanford University
Outcome results
None listed