Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The investigators propose a nonrandomized, Phase I study to assess the safety of infusion of NK cells that will be selected from sibling donors and infused to patients with hematological malignancies early following allogeneic stem cell transplantation.
Allogeneic hematopoietic stem cell transplantation (HSCT) is a very effective treatment for a number of hematological malignancies but relapse remains a major problem, especially in patients with high risk disease. Natural killer (NK) cells are immune cells that recognize and kill virally infected cells and tumor cells. NK cells are identified by the expression of the CD56 surface antigen and the lack of CD3. Their ability to kill tumor cells makes them promising to evaluate as effector cells for immunotherapy.
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Infusion of donor derived ex-vivo selected NK cells to patients after transplant | Procedure | Infusion of donor derived ex-vivo selected NK cells to patients after transplant | ||
| Haematology / Blood chemistry sampling | Procedure | Haematology / Blood chemistry sampling, collection of blood for ancillary lab research |
| Measure | Description | Time Frame |
|---|---|---|
| Safety and toxicity donor CD56+CD3- NK cells | To evaluate the safety and toxicity of escalating doses of ex vivo selected donor CD56+CD3- NK cells, adoptively infused on day 7 following sibling allogeneic stem cell transplantation in patients with hematological malignancies. We will specifically look for the proportion of patients who develop infusion related toxicity. Toxicity will be defined as per the Common Terminology Criteria for Adverse Events v3.0 (CTCAE). | Day 28 post NK cell infusion |
| Measure | Description | Time Frame |
|---|---|---|
| Donor neutrophil and platelet engraftment | Donor neutrophil engraftment (Neut > 0.5 x10^9/L) and platelet engraftment (Plt > 20 x10^9/L) | Day 28 post stem cell infusion |
| Rates of acute GVHD (grade 2-4) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Katy Rezvani, MD | Imperial College Healthcare NHS Trust | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hammersmith Hospital | London | W12 0HS | United Kingdom |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Risk of acute GVHD
| Day 100 post stem cell infusion |
| Relapse rate | Relapse | 1 year post stem cell infusion |
| ID | Term |
|---|---|
| D007938 | Leukemia |
| D019337 | Hematologic Neoplasms |
| ID | Term |
|---|---|
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D006402 | Hematologic Diseases |
| D006425 | Hemic and Lymphatic Diseases |
| D009371 | Neoplasms by Site |
Not provided
Not provided