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| ID | Type | Description | Link |
|---|---|---|---|
| BMT162 | Other Identifier | OnCore | |
| 95070 | Other Identifier | Alternate Stanford IRB |
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| Name | Class |
|---|---|
| National Institutes of Health (NIH) | NIH |
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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.
This study did not advance to dose expansion.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Cytokine-induced Killer Cells | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cytokine Induced Killer Cells | Drug | 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 |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Inclusion Criteria:- Evidence of recurrent or persistent hematologic malignancy following HLA matched allogeneic hematopoietic cell transplant
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| Name | Affiliation | Role |
|---|---|---|
| Robert S Negrin | Stanford University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stanford University School of Medicine | Stanford | California | 94305 | United States |
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| ID | Term |
|---|---|
| D009101 | Multiple Myeloma |
| ID | Term |
|---|---|
| D054219 | Neoplasms, Plasma Cell |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D020141 | Hemostatic Disorders |
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|
| To optimize the ex vivo expansion of CIK cells using a continuous perfusion culture system. | 21-28 days |
| D014652 |
| Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D010265 | Paraproteinemias |
| D001796 | Blood Protein Disorders |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D006474 | Hemorrhagic Disorders |
| D008232 | Lymphoproliferative Disorders |
| D007160 | Immunoproliferative Disorders |
| D007154 | Immune System Diseases |